Student Projects
Evidence Based Clinical Practice Guideline

Premature rupture of membranes at term: An evidenced-based clinical practice guideline for home birth midwives

Susan Karimi

Susan Karimi, CNM
MW21 Critical Inquiry II, Completion of Final Project

Abstract
Premature rupture of membranes (PROM) is defined as the rupturing of the fetal membranes at term, prior to the onset of uterine contractions (Duff, 1996; King, 1994). PROM is a relatively common occurrence, affecting 5% to 10% of pregnancies, with 60% to 80% occurring after the 37th week of gestation (Duff, 1996; King, 1994). Risks associated with PROM include maternal and neonatal infection, cord compression, cord prolapse, and malpresentation (King, 1994). As time passes with no ensuing labor, the risks of problems, particularly of infection, rises. Numerous options for treatment include an immediate induction of labor, the induction of labor after a set number of hours, expectant management while hospitalized, or out-patient expectant management. The best option for the management of PROM remains controversial due to inconsistencies within the literature (Duff, 1996; King 1994; Hannah, Hodnett, Willan, Foster, Di Cesso, & Helewa, 2000). Furthermore, the research to date has been primarily conducted on hospitalized populations. Women who have planned a home birth are often reluctant to initiate the more aggressive treatment options for PROM because of the need for hospitalization. The home environment may offer protective advantages for these women, as common hospital interventions that may increase certain risks, such as vaginal examinations and internal fetal monitoring, are not performed or are not as frequent. The literature review revealed that the risk of infection is low for up to 72 hours after PROM. Existing research also shows that most women will enter spontaneous labor within 72 hours of PROM, and that women planning home birth prefer home care with minimal use of intervention. The exact duration for expectant management of PROM remains the primary area of debate. The conceptual framework - environment affects health - guides this inquiry. An evidenced-based clinical practice guideline is offered out of this inquiry for use in the midwifery management of PROM in home birth.

CHAPTER 1: Introduction to the problem

Premature rupture of membranes (PROM) is commonly defined as the rupturing of the amniotic sac before the onset of uterine contractions and occurring after 37 weeks of gestation (Duff, 1996; King, 1994). The time between membrane rupture and onset of contractions is known as the latency period. Prior to rupture, the amniotic sac serves as a barrier to infectious organisms (King, 1994). The intact amniotic sac also provides a cushion for both the fetal head and maternal tissues, so that pressure from uterine contractions is distributed more evenly and gently (King, 1994). The umbilical cord is cushioned as well, protecting the cord from undue force. When the membranes rupture, these protections are lost. The management of PROM, therefore, is designed to minimize the risk of injury, particularly of infection, for both the woman and the fetus.

There are several possible contributing factors to PROM. Existing infection is one possible cause, with N. gonorrhoea, C. trachomatis, T. vaginalis, and group B-hemolytic streptococci as contributing pathogens (Gabbe, Niebyl, & Simpson, 1996). According to this theory, one or more of these organisms may ascend through the cervix. An inflammatory reaction within the fetal membranes and/or uterus is initiated. As a result, injury to the fetal membranes may occur by the direct production of protease and other enzymes, or indirectly through cytokine production from the maternal immune response. Smoking, inadequate nutritional intake, and coitus within 9 days of delivery may also contribute to PROM. Finally, women with PROM, especially greater than 72 hours, may suffer from a deficiency in prostaglandin production (Enkin et al., 2000). Inadequate prostaglandin production may contribute to delayed labor and result in poor progress of cervical dilation.

Current community standards of care call for medical intervention to begin immediately or within 18 hours of PROM despite research evidence that longer waiting periods may be safe (Duff, 1996; Monzurkewich & Walk, 1997). Such interventions include pharmacological induction of labor and/or the use of intravenous antibiotics. Risks associated with these medications include failed induction, cesarean delivery, antibiotic resistance, and allergic reaction (Keirse, Ottervanger & Smit, 1996). The research to date has been conducted primarily on women treated in hospital environments (Mozurkewich & Walf, 1997). However, this data may not be applicable to women in the home setting due to the absence of virulent hospital microorganisms and the use of fewer medical interventions (Rooks, 1997).

Women who choose home birth, and the midwives who serve them, are philosophically unique (Anderson & Murphy, 1995; Rooks, 1997). Pregnancy and birth are viewed as normal, healthy life processes. The process is believed to develop best when unhindered by artificial rules, medications, and foreign environments. Women consider their social, spiritual, cultural, and economical needs to be as important as the physiological birth process. Freedom of self-expression, control over who will share this most personal experience with them, and cost-effectiveness are sought. Home birth midwives meet these unique needs through provision of individualized care. Hours of time are invested in getting to know women and their significant relationships with others. An intimate relationship develops between the woman and her midwife, thus enabling the midwife to intuitively recognize subtle changes in a woman's biopsychosocial health status. When labor ensues, the midwife stays with the woman, closely monitoring for signs of health or pathology while offering individualized comfort care. Interventions are only used when clearly indicated by medical need. The more naturalistic practices used in the home setting offer a very different, and sometimes controversial, option for birth than is commonly found in hospitals (Rooks, 1997). This article reviews the controversies surrounding PROM management and suggests an evidenced-based clinical practice guideline (EB-CPG) for the midwifery management of PROM in planned home birth.

Scope of the problem

PROM occurs in approximately 5% to 10% of all pregnancies, with 60% to 80% occurring at term (Duff, 1996; King, 1994). Approximately 4 million births occurred in the United States in 2001 with roughly 1% of those taking place in the home setting (National Center for Health Statistics, 2002). Therefore, an estimated 2000 to 4000 cases of PROM in planned home birth will occur annually.

In the 1950s, the primary concern related to PROM was the risk of maternal and/or neonatal infection (Enkin et al, 2000). Such episodes of infection were associated with a high risk of mortality. Therefore, immediate induction of labor was recommended. Today, however, current obstetrical knowledge has evolved. We now know that elimination of vaginal examinations after PROM significantly lowers the incidence of infection (Keirse et al, 1996). Monitoring for clinical signs of infection is also more advanced, with cultures that detect DNA fragments. Monitoring for fetal well-being is also better through fetal surveillance testing such as non-stress testing (NST) and auscultated acceleration testing (Paine et al, 2001). Deaths noted in earlier years primarily occurred after prolonged periods of severe infection, where antibiotic therapy was inadequate by today's standards (Enkin et al, 1996). Such deaths are a rarity today (Keirse et al, 1996; Enkin et al, 1996).

Significance to women's health

Women seeking home birth desire a midwifery model of care that promotes nonintervention, except when clear medical need is demonstrated (Rooks, 1997). Women choosing home birth expect to deliver their babies without medication while in the privacy of their own environments. An otherwise healthy pregnant woman who experiences PROM would suddenly find herself thrust into the world of hospital care and pharmacological intervention by those authors and care providers who promote immediate labor induction or antibiotic prophylaxis, often without listening to and acknowledging women's concerns. Without clear evidence of medical need, such women would potentially feel robbed of their home birth plans. In the event of iatrogenic complication from the recommended interventions, women would also experience avoidable threats to their health and that of their babies. For every woman planning a home birth, provider support for these plans is critical. Recommendations for transfer to the hospital should only be made under clear condition of need so that the woman and her growing family may have the best start possible.

Significance to midwifery

Midwives provide evidenced-based health care that is individualized for each woman served (ACNM, 1989). Clients who utilize midwives thus benefit from safe, cost-effective care (ACNM). An important component of midwifery care includes measures to reduce the use of expensive medications and cesarean surgeries. Specifically, care provided by skilled midwives in the home setting has been shown to be a safe and cost-effective option (ACNM, 2003). The expectant home management of PROM has the potential to dramatically reduce overall health expenses for society. Furthermore, cutting back on the need for induction of labor, along with associated cesarean sections for failures, may help to achieve the Healthy People 2010 goal for a 15% cesarean section rate (Keirse et al., 1996; Healthy People 2010). Establishment of a clear practice guideline for the midwifery management of PROM in home birth is essential.

Gaps between current practice and evidence based practice

The most effective management strategy for term pregnancies experiencing PROM remains uncertain. Some authors recommend immediate induction of labor for all women (Duff, 1998; Garite, 2001). Others have suggested expectant management lasting up to 72 hours as long as there are no signs of infection or fetal distress (King, 1994; Keirse et al., 1996; Shalev, Peleg, Eliyahu, & Nahum, 1995). Due to these inconsistencies in the literature, no definitive clinical guideline has yet been determined.

Current trends, therefore, have been towards immediate induction as a means to decrease the perceived risk of infection (Gabbe et al, 1996). The research actually shows that infection risks are most directly related to the use of invasive vaginal examinations (Keirse et al, 1996; Enkin et al 2001). When vaginal examinations are eliminated, the relationship between infection and the time interval between PROM and birth virtually disappears (Kappy et al, 1982). The gap between the research and current practice is vast.

In order to bridge that gap, we need to eliminate invasive vaginal examinations and weigh any risks of medical induction against a woman's individual risks for PROM related complications. Avoidance of unnecessary and potentially harmful practices is common to home birth midwifery care. Monitoring and risk screening techniques used by midwives in the home setting are historically noninvasive and protective of healthy physiological processes. Simply offering more frequent monitoring to the care that home birth midwives already employ will facilitate safe, evidenced-based expectant home management for PROM.

Theoretical and operational definition of terms

The theoretical definition of PROM (premature rupture of membranes) is the spontaneous rupture of the fetal membranes prior to the onset of regular uterine contractions (Enkin et al, 2001). For the purposes of this inquiry, the operational definition of PROM is the spontaneous rupture of the membranes between 37 and 42 weeks gestation, prior to the onset of regular and/or increasingly intense uterine contractions. The operational definition assumes that the woman has been diagnosed with PROM by sterile speculum examination and/or microscopic evaluation of pooled fluid near the cervix.

Home birth is theoretically defined as a birth that occurs in the mother's usual place of residence. The operational definition of home birth is expanded to include any non-institutional setting in which the mother feels at home, such as her private residence, a family member's residence, the home of a friend, or any outside component of the aforementioned locations. While the operational definition of home birth has been restricted for the purposes of this paper, women and practitioners who want to follow a low intervention policy can do so regardless of birth setting (ie: freestanding birth centers or hospitals) until demonstrated need for induction with pharmaceutical methods. At such point, setting capabilities for emergency response need to be considered.

Assumptions and philosophical approach

The midwifery philosophy of care includes a strong belief that pregnancy and birth are normal processes. The medical model, in contrast, views birth as a risky endeavor. The following table further delineates the differences between the two philosophical approaches (Frye, 1995; Rooks, 1997).

Table 1: Practice models

MIDWIFERY MODEL
MEDICAL MODEL
Client directed carePractitioner directed care
Focused on the person as a whole beingFocused on symptoms
Care provider is an expert in healthCare provider is an expert in pathology
Care provider guidesCare provider treats
Care is woman centeredCare is institution centered
Care is naturalCare is allopathic
Care is low techCare is high tech
Birth is safeBirth has risk

Each health care provider has a unique philosophy and practice style. The comparison of models is a generalized list. But individual practitioners may actually incorporate a variety of the beliefs shown. Overall, midwives believe that women are strong and intelligent people who are capable of making their own decisions about their health. A midwife's job, therefore, is to assist the woman through the various stages of her health events.

When a health care provider believes in client directed, woman centered, natural low tech care, the home is a logical location for birth. The home environment is a most personal aspect of the woman herself. In her own home, the woman demonstrates her unique personality, values, and social circumstances through her choice of decor, food, and guests. Spiritual and cultural components are more easily individualized and incorporated in the woman's birth, because the midwife can readily see evidence of these aspects of the woman's life. Self-determination and autonomy are respected. The home is the woman's sanctuary from the wider world, and is thus considered to be a safe and private domain. The woman feels more in control within this space than anywhere else on earth. In lieu of the evidence, the home also becomes the logical location of the expectant management of PROM. Fewer interventions, common in midwifery practice, offer the lowest risk of infection.

Limitations of the state of the science in this area


Several limitations of the science of PROM management exist. The scientific process is demonstrated most clearly by prospective, randomized clinical trials. A study group and a control group are utilized, with subjects being randomly assigned to one or the other. This random assignment is not amenable to home birth because women and midwives who choose home birth do so out of a strong sense of self-determination. Few women planning home birth would agree to predetermined plans of care based solely on randomized assignment. Therefore, a clinical trial is not an acceptable method for the study of PROM management in home birth.

The science for PROM management in home birth is further limited by hospital-based study. To date, no study has looked prospectively at the differences between complete home management versus hospital management of PROM. Conclusions from such studies cannot be generalized to the home birth setting.


Lastly, the availability of subjects for this study topic is low. Only 1% of births in the United States takes place in the home setting. Even fewer births experience PROM. Finding an adequate number of willing participants to join such a study could pose to be a great challenge, since women choosing home birth tend to view their birth experiences as a most private, intimate event. Some midwives who work in the home setting might also be unwilling, or unable, to participate in a study due to time constraints or legal concerns. Nonetheless, further study should be attempted so that clinical practice can be more reflective of home and midwifery specific evidence.


CHAPTER TWO: Review of the literature

Home birth with midwives is a safe, satisfying, cost effective option for women (ACNM, n.d.). Due to careful risk screening and judicious use of medical technology, the risk of experiencing complications is low (Anderson & Murphy, 1995). In approximately 5% to 10% of all pregnancies, however, premature rupture of membranes (PROM) does occur, and 60% to 80% of these take place at term (Duff, 1996; King, 1994). The length of time allowed between PROM and medical intervention is controversial due to inconsistencies within the literature. As a result, definitive clinical guidelines have not been determined. Since midwifery philosophy includes a belief in the use of intervention only with clear medical indication, home birth midwives are currently handicapped by overly conservative PROM management community standards (Keirse, Ottervanger & Smit, 1996). In order to ensure the safe, evidenced-based midwifery management of PROM for home birth, a thorough review of the literature is necessary.

The literature is being reviewed in order to develop an evidenced-based clinical practice guideline for PROM management in home birth. Relevant studies were analyzed following an on-line search of MEDLINE and CINAHL, using keywords home birth, home birth and safety, PROM, prelabor rupture of membranes, premature rupture of membranes, and PROM and infection. A total of thirty-seven full-text articles were obtained through the Iowa Methodist Hospital Health Sciences Library. For inclusion in this review, each article was required to be a report of actual research. Ten of the most pertinent studies are discussed.


Summary and limitations of the existing literature

This review of the literature reveals interesting information regarding PROM. First, the literature consistently shows that the 80% to 90% of women will enter spontaneous labor within 72 hours of PROM. The risk of clinically significant infection, furthermore, remains low (1.0% to 3.0%) when vaginal examinations are avoided. When frequent vaginal examinations and/or internal fetal monitoring are employed, however, the risk of chorioamnionitis can climb to an alarming 10.1%. Midwives provide a significantly reduced number of vaginal examinations and do not employ internal fetal monitoring at home (Anderson & Murphy, 1995). Women express higher levels of satisfaction with this type of management in the home setting (Anderson & Greener, 1991; Hannah et al., 2000). Yet, no research to date has investigated the exclusive home expectant management of PROM by midwives. This literature review indicates a need for further study of the expectant midwifery management of PROM for women planning home birth. Conceptual Framework

Conceptual frameworks and theories are essential to scientific understanding so that research can be used to guide practice. The type of care provided, along with the manner in which that care is provided, must be clearly described in a systematic way for better understanding of practice. A conceptual framework helps to explain the fundamental concepts or philosophical paradigms of a study. The hypothesis, methodology, and interpretation of study findings emerge from this framework. Theory goes even further. The theory explains the way in which two or more concepts are interrelated (Polit, Becker, & Hungler, 2001). Ultimately, theory is used as the foundation for research, and research can be used to test the worth of a theory.

The conceptual framework guiding this proposal is that environment affects health outcomes. The environment includes the physical surroundings, sociocultural milieu, and the caring efforts provided by the practitioner (Thompson, Burke & Conklin, 1989; Watson & Smith, 2002). Health is defined as the physical, emotional, mental and social well-being of an individual person. Outcomes are the end result of the health event.

The theory for this proposal is that the expectant management of PROM is enhanced by the home environment. The study hypothesis is that expectant midwifery management of PROM is safe in the home environment for up to 72 hours. Variables to be considered include the existence of any preexisting or coexisting risk factors, the duration of expectant management, the type and amount of assessment provided (ie: laboratory analysis, vaginal examinations), the type and amount of intervention utilized (ie: natural efforts to encourage labor vs medication), and the type of practitioner involved. The environment of the home, along with the caring philosophy of midwifery practice, can be utilized to increase the duration for the safe expectant management of PROM.

The home environment is where women feel most safe and secure (Anderson & Murphy, 1995; Hannah et al., 2002). In one's home, a woman's autonomy and sense of control are enhanced because the power dynamics between client and provider are equalized. The provider is an invited guest into the woman's environment. The woman decides what activities to follow, what foods to eat, when to sleep, and who to invite into her presence. The woman's coping abilities are promoted through the presence of her usual nurturing relationships. She enjoys greater levels of privacy, a peaceful atmosphere, and a familiar environment for promotion of her normal physiological processes (Rooks, 1997, p.347). The environment of the woman's home is one of her creation, and helps to shape the type of care given by the midwife. Options for mobility, music, guests, scents, decor...are orchestrated by the woman herself. There is no pressure to conform to the tastes, practices, and procedures of environments that are designed by someone else. Furthermore, the very absence of obstetrical machines, drugs, and surgical suites found in hospitals relieves the woman of the need to consider such things. A women planning home birth anticipates that her perception of safety and security enjoyed throughout her pregnancy will follow into her labor, birth, and through her postpartum experience.

Midwifery is a caring philosophy based on a strong belief that pregnancy and childbirth are healthy, normal life events (Rooks, 1997, p 126). Preventative health screening and wellness education are utilized in order to work with the woman for maximal health outcome. The relationship between women and midwives is one of partnership. This philosophy respects the individuality and autonomy of women. The emphasis is placed on the woman's abilities, rather than on any potential abnormality or health threat. In the event of a challenge to health, such as PROM, the midwife provides continued surveillance and takes steps to reduce risk. Thus, the woman's healthy state is promoted even in times of potential difficulty.

Midwifery practice also includes interventions based on clinical need. The old adage "first do no harm" most accurately describes a midwife's plan of care (Rooks, 1997). Since PROM creates an slight increase of risk for infection, the midwife works to avoid procedures that could introduce bacteria into the uterine environment. Vaginal examinations are not performed. Internal fetal monitoring is avoided unless evidence of fetal compromise is demonstrated. As long as the midwifery assessment reveals health, the midwife encourages the women to continue her regular routine. Caring physical and emotional support is provided by the midwife in order to facilitate continued wellness.

The literature has revealed that expectant management, with minimal or no vaginal examinations, leads to spontaneous delivery without increasing infection for up to 72 hours (Hannah et al., 2000; Kappy et al., 1982; Ladfors, 1996; Ottervanger et al., 1996; & Shalev et al., 1995). Care within the home setting has also been shown to be safe for properly monitored women when interventions are kept to a minimum. Since midwives provide individualized care based on the woman's biopsychosocial needs, PROM management can and should be an option in the home setting. This proposal calls for a prospective study of the expectant midwifery management of term PROM in the home setting in order to develop an evidenced based clinical practice guideline.

Conceptual Map

PROM = premature rupture of membranes
H = home
EM = expectant management
(+)HO = positive health outcomes
EBCPG = evidenced based clinical practice guideline

PROM + H + EM < 72 hours --------> (+)HO-------->EBCPG

CHAPTER THREE: Evidenced Based Clinical Practice Guideline

Premature rupture of membranes is a fairly common problem, affecting 5% to 10% of term pregnancies. There is lack of agreement, however, about the best way to manage this condition in the otherwise low risk woman. The rush to immediate induction may not be in the best interests of women planning birth at home. Creation of an evidenced-based clinical practice guideline (EB-CPG) for PROM management in home birth addresses this problem in the home environment, with implications for management options for those low risk women planning hospital birth as well. Women who seek home birth desire increased autonomy, less medical intervention, seek increased individualization of care, and expect freedom to express their personal identities. These women believe strongly in the spiritual and emotional components of the birth experience. They also are quite willing to accept responsibility for their health care decisions. Home birth midwives become invited guests into the woman's domain, and the woman runs the show (ACNM, 2003; Rooks, 1997). Home birth midwives are also unique. Such practitioners acquire advanced skill in early risk assessment. Screening for abnormalities continues throughout pregnancy. The midwife provides not only physical health care, but addresses psychosocial and emotional/spiritual needs as well. This holistic focus of home birth midwifery leads to decreased use of pharmacologic drugs and surgeries. Promotion of normal life processes through healthy lifestyle choices is the focus. Preventative health may also include nutritional counseling, activity training, and use of traditional or complementary therapies such as herbs and acupressure. As a result of this special care and a high degree of personal responsibility, women enter home birth at maximal health. The need for expensive medical drugs and interventions is thus avoided or reduced to a minimum. Studies to date addressing PROM management have been conducted primarily on hospitalized women (Egarter et al, 1996; Keirse et al, 1996; McCaul et al, 1997; Seaward et al, 1997). Variable methods, interventions, and time frames have been used. Women subject in the studies most often did not receive the type and amount of preventative education and monitoring commonly offered by home birth midwives. Yet, the bulk of these studies have shown that the risks of PROM related complications are low. When vaginal examinations are avoided, the most concerning risk of infection is reduced from approximately 10.1% to between 1% and 3% (Keirse et al, 1996). Vigilant monitoring can greatly enhance the safety of PROM management. In the absence of overt uterine infection, fetal compromise, or malpresentation, PROM can be safely managed expectantly for 72 hours or more. The home setting combined with midwifery care provides an excellent avenue for this longer duration of expectant management.

Method of development

A. Process used An extensive review of the literature was conducted in order to gather information on home birth, PROM, and related management options. Textbooks were used from midwifery, nursing, and obstetrical disciplines. A search of relevant midwifery, nursing, and medical journals was performed through MEDLINE and CINAHL, using keywords home birth, home birth & safety, PROM, prelabor rupture of membranes, premature rupture of membranes, and PROM & infection. Information regarding PROM management was also harvested from American College of Nurse-Midwives (ACNM) publications, American College of Obstetricians and Gynecologists (ACOG) documents, and from an on-line listserve of American midwives. Over 150 journal titles were identified and their abstracts retrieved. The abstracts were further narrowed to 30 full text articles, obtained through the Iowa Methodist Medical Center library and reviewed. The scientific evidence considered includes prospective and retrospective research studies summarized in tabular format below.

B. Evidence considered
Table 3: EVIDENCE TABLE OF RETROSPECTIVE HOME BIRTH
and/or
MIDWIFE STUDIES
Study
Author / Year
Grade of Evidence
A=true
experiment
B= quasi-
experiment
C= correlation
D= description
Study Design and Validity
-Cohort study
-Case Control
-Case series
-Case reports
-Expert opinion
Statistics Reported
-Odds Ratio
-Relative Risk
-Confidence Interval
-P value
Conclusions/Opinions
Anderson & Murphy (1995)
D
Retrospective
cohort survey
N=11,788 home births.
29 states were represented.
66.2% response.
Transfer rate = 8%.
Cesarean rate = 3%.
PROM = 13.3%.
PROM related maternal infection = 19 out of 905 intrapartum transfers (<0.02%).
Neonatal sepsis of unspecified etiology = 5 out of 905 intrapartum transfers (0.04%) with no related deaths.
Cord prolapse = 8 out of 905 intrapartum transfers (0.07%) with no related deaths.
Intrapartum neonatal mortality = 2/1000 (0.2 per 1000 after anomalies excluded).
No maternal deaths.
Offers important descriptive information regarding CNM attended home birth outcomes. Although this study was not PROM specific, statistical calculations showing PROM related infections were included. Statistical findings show similar outcomes to those in other studies, clearly demonstrating a low risk of infection among the studied home birth population. Findings show relative safety of CNM attended home birth.
Anderson (1999)
D
Retrospective cohort surveyN = 11, 788 intended home births.
N = 11,592 hospital births.
Mean cost of hospital birth in 1991 = $5382.
Mean cost of home birth in 1991 = $1844.
Intrapartum home birth transfer rate = 8%.
Cesarean rate for home birth = 3%.
Cesarean rate for planned hospital birth = 8.3-26.9%).
Neonatal mortality for home birth = 2 / 1000.
Neonatal mortality for hospital birth = 2.2 /1000.
The average financial cost of home birth is 68% less than birth in hospital. Home birth also offers significantly lower rates of cesarean section and neonatal mortality. For women transferred to hospital after intended home birth, total costs were similar to planned hospital births, due to less expensive prenatal midwifery care and fewer intrapartum / postpartum interventions.

This study did not identify PROM and PROM related infections specifically. However, study results do contribute to the data showing home birth as a safe option. Infection rates of non-specified etiology in home birth are similar to rates of infection in hospital birth.
Davidson (2002)
D
Retrospective comparative studyN = 803 high risk subjects.

PROM = 18.6% (<0.3% of the 5487 clinic patients).

Maternal fever = 3%.

Cesarean rate for the high risk CNM births = 17% compared to 21% for national data set.

5 minute Apgar of 7 = 1.7% for CNM high risk births.

5 minute Apgar of 7 = 2.5% for national data set.
The reported incidence of PROM among the total number of clinic patients is similar to rates reported by other studies.

CNM management of high-risk women results in higher numbers of spontaneous births, fewer instrumental births, fewer cesarean sections and higher 5-minute Apgar scores as compared to the national data set.

The authors recommend further research regarding the higher incidence of maternal fever in the midwifery sample, stating frequent overall underreporting within birth certificate data.
The study indicates that CNM care of higher-risk women result in favorable outcomes.
Declercq (1995)
DRetrospective longitudinal studyN = 82,210 home births in the United States from 1989-1992. CNMs attended 12% of the births, physicians attended 20%, and other midwives 30.5%. The attendants for the remaining 37.5% of home births were not identified.
The average home birth client is Caucasian, married, older, para >3, lesser educated, and less likely to abuse substances. Home births are more common in the southwestern and western states.

The health outcomes for babies born at home compared favorably to those born in hospitals.
Durand (1992)
D
Retrospective comparative studyN = 1707 home births.
N = 14,033 hospital births.
Intrapartum transfers from home group = 7.4%.
Cesarean rate = 1.46% home vs16.46% for hospital group.
Assisted delivery = 2.11% home vs 26.60% hospital.
Perinatal death = 1.0% compared to 1.33% for hospital group.
This study reflects statistics for a lay midwifery service that includes home birth care of higher risk populations (breech presentation, multiple gestation, higher parity, and fewer prenatal visits). Perhaps due to this reason, the perinatal mortality rate for the home birth population is higher in this study than in other studies. However, the perinatal mortality rate is comparative to that for the hospital group. Despite the inclusion of higher risk subjects, this outcomes for the home birth population are comparatively safe to the hospital birth group.
Jackson & Bailes (1995)
D
Retrospective Review of international researchN not defined.
Looked at an undefined number of international studies on the safety of home birth with trained attendants, stringent screening criteria, and physician consulting opportunities. No statistical tables were provided.
The studies reviewed, totally tens of thousands of birthing women, consistently demonstrate home birth outcomes to be "at least as good as, if not better than" hospital birth. No study definitively showed that hospitals are safer.
Janssen et al (1994)
D
Retrospective comparative studyN = 6944 licensed midwife (LM) out-of-hospital births.
N = 23,596 physician (MD) attended low-risk hospital births.
N = 14,777 CNM attended low-risk hospital births.
N = 4054 CNM out-of-hospital births. Low birth weights: LM group = 10.9/1000, MD group = 16.5/1000 (RR=0.8, 95% CI 0.6-1.0). CNM in hospital low APARs = 10.1/1000. CNM low Apgars out-of-hospital = 9.9/1000. Neonatal deaths: LM group = 1.7/1000, MD group = 1.0/1000 (RR=1.0, 95% CI 0.7-3.0). Neonatal deaths for CNM in hospital group = 1.6/1000 and for CNM out-of-hospital = 1.7/1000.
The risk for low birthweight was significantly lower for licensed out-of-hospital midwives than for the physician group, and similar to that for nurse-midwives in either setting.

No differences were found in 5-minute Apgar scores, neonatal mortality, or postneonatal mortality between licensed midwives and the other groups.

This study suggests that out-of-hospital births attended by appropriately trained midwives (both LM and CNM) may be as safe as physician or CNM attended hospital birth.
Olsen (1997)
D
meta-analysisN = 24,092 home birth women from 6 controlled observational studies.
No significant differences found for perinatal mortality (OR=0.87, 95% CI 0.54-1.41).
Low Apgar scores were less prevalent for the home birth group (OR = 0.55; 0.41-0.74).
Fewer cesarean sections for the home birth group (0.05-0.31).
No maternal deaths.
Home birth leads to a lower use of medical interventions. There is no evidence among these studies to support a claim that hospital birth is safer than planned home birth. Home birth is a viable option for low-risk women assisted by a skilled practitioner.
Pang et al (2002)
D
Retrospective analysis. Poor validity due to examiner bias (inclusion of statistics from preterm births) and conclusions based solely on birth certificate data.N = 6133 home births.
N = 10,543 hospital births.

Initial analysis included births >34 wks. Results: neonatal mortality = 3.5/1000 home births, 1.7/1000 hospital births (RR 1.99, 95% CI 1.06, 3.73).

Secondary analysis was performed for subjects > 37 wks gestation. Results: neonatal mortality =3.3/1000 home births, 1.7/1000 hospital births (RR 2.09, 95% CI 1.09, 3.97).
The authors concluded that the risk of neonatal death was "almost twice as high for infants born of women intending to deliver at home as for infants born to women delivering in hospitals."

This study is likely biased. The researchers relied only on birth certificate data which does not indicate planned vs unplanned locations of birth. Furthermore, study results included statistics from preterm births (>34 wks) that are not usually accepted in home birth practices. The possibility that unplanned, higher-risk home births were included cannot be ruled out.

Table 4: EVIDENCE TABLE OF PROSPECTIVE HOME BIRTH STUDIES
Study
authors
Grade of Evidence
A=true
experiment
B= quasi-
experiment
C= correlation
D= description
Study design

Sample size and descriptionResearch procedureMeasures used & their reliability & validityStatistics reported
(include type of statistic reported & p value/confidence intervals as indicated)
Study results & midwifery perspective
Murphy & Fullerton
(1998)
D
Prospective descriptive studyN = 1404 intended home births.

One thousand, two hundred twenty-one (1221) remained eligible at onset of labor.
All women accepted into one of 29 CNM home birth practices from 1994 through 1995 were enrolled in this study. Individual CNM practice guidelines were used to determine eligibility for home birth. Uniform data collection forms were developed and pilot tested. Hospital records were reviewed for all women and newborns transferred. Intrarater and interrater reliability were calculated using simple percent agreement, ranging from 92%-96%. Outcomes were compared using x2 and t test procedures. The probability value was set at .05%.

PROM = 4/1404 (<1.0%).
Intrapartum transfer = 8.3%. Of these, 5.2% transferred for PROM and all infants remained well. Two neonates were evaluated for sepsis.
Overall fetal/neonatal mortality for completed home births = 1.8/1000.
Birth can be conducted safely at home, as long as care is provided by qualified CNMs within a system that allows for physician collaboration and hospital transfer, when indicated.

Table 5: EVIDENCE TABLE OF RETROSPECTIVE PROM STUDIES
StudyGrade of Evidence
A=true
experiment
B= quasi-
experiment
C= correlation
D= description
Study Design and Validity
-Cohort study
-Case Control
-Case series
-Case reports
-Expert opinion
Statistics Reported
-Odds Ratio
-Relative Risk
-Confidence Interval
-P value
Conclusions/Opinions
Egarter et al (1996)
D
meta-analysisN = 657 women from seven clinical trials with PPROM between 23 and 34 weeks gestation. Antibiotic treatment most frequently included IV ampicillin 2gm q6H X 24-48H, followed by oral ampicillin.

Odds ratio and 95% confidence interval were calculated for each study separately, then for all studies combined. Statistics testing followed x2distribution with N =1 degree of freedom.

Results: Antibiotic therapy reduced the risk of neonatal sepsis by 68% (OR 0.32, CI 95% 0.16-0.65, p=0.001). There was no effect on neonatal mortality (OR 0.92, CI 95% 0.46-1.81). There was no effect on necrotizing enterocolitis (OR 1.27, CI 95% 0.61-2.62).
The authors of this meta-analysis concluded that antibiotic prophylaxis for preterm PROM does improve neonatal morbidity.

The use of antibiotics for preterm PROM can be beneficial, especially if the medication regimen allows the pregnancy to continue.

Alteration of intestinal flora can be a potentially serious side effect of broad spectrum antibiotic use. This study found no increase of such side effect.

The effect of prophylactic antibiotic administration in term PROM are not known. Due to the lack of impact on neonatal mortality in this metaanalysis, more study is indicated before prophylactic antibiotics in term PROM can be recommended.
Ferguson et al (2002)
C
Ex-post facto, case-controlled study.

Women were recruited for the study on admission to one of three tertiary care hospitals. Populations were matched for gestational age and previous vitamin supplementation. Dietary intake was determined through use of the Block Healthy Habits and History food frequency questionnaire.

This study demonstrates poor validity due to the very small sample size and lack of control over variables.
N = 46 women with PPROM between 23-35.6 weeks gestation. This group was compared with similarly matched women having intact membranes.

There were no differences in homocysteine, red blood cell folate, or vitamin B levels of either group. There were no differences in dietary intake. Lower hemoglobin levels were found in women with PPROM (P<0.001). Women with PPROM were also 3 times more likely to have family incomes < $25,000 (OR 3.1, CI 95%, 1.6-6).
PPROM is associated with lower socioeconomic status. Women with PPROM have lower hemoglobin levels, but show no other differences in nutritional level.

Midwives provide greater amounts of nutritional education, socioeconomic assessments, and counseling. These preventative midwifery activities may reduce some of the variables associated with PPROM by this study.
Mercer (1998)
D
Meta-analysis of 15 controlled trialsN = 2265 women in 15 controlled trials.

Chorioamnionitis: Reduced with IV antibiotic therapy from summary risk of 26.1% to 15.2%. Oral antibiotic therapy prolonged pregnancy, but did not reduce overall maternal infection.

Neonatal sepsis: Intravenous antibiotics reduce neonatal sepsis (summary risk: 7.0 versus 10.5%, OR: 0.65, P = 0.01).

Oral therapy does not reduce maternal or neonatal morbidity.
Intravenous antibiotic therapy can reduce the incidence of chorioamnionitis in PPROM.

Oral antibiotic therapy was not shown to be effective. It may offer benefit to prolongation of pregnancy in PPROM, but does not reduce maternal or neonatal morbidity or mortality.
Mozurkewich & Wolf (1997)
D
Meta-analysis of 23 controlled trialsN = 7493 women from 23 controlled trials reviewed three term PROM management options: immediate oxytocin induction, conservative management (delayed oxytocin), or vaginal PGE2 induction.

Cesarean deliveries: Oxytocin vs conservative (OR 1.24, 95% CI 0.89, 1.73). PGE2 vs conservative (OR 0.67, 95% CI 0.34, 1.29).

Chorioamnionitis: Oxytocin vs conservative (OR 0.91, 95% CI, 0.51, 1.62). PGE2 vs conservative (OR 0.68, 95% CI 0.51, 0.91). PGE2 vs oxytocin (OR 1.55, 95% CI 1.09, 2.21).

Neonatal infection: oxytocin vs conservative (OR 0.73, 95% CI 0.47, 1.13). PGE2 vs conservative (OR 1.06, 95% CI 0.67, 1.66). PGE2 vs oxytocin (OR 1.50, 95% CI 0.91, 2.45).
Results using the Mantel-Haenszel fixed-effects procedure favored oxytocin induction for reduction of chorioamnionitis and endometritis. Results using random-effects procedure showed no statistically significant differences.

Immediate oxytocin induction does slightly increase cesarean deliveries. Although rates of maternal and fetal infections were higher with expectant management, the overall number of infections is too small to be statistically significant.

From a midwifery perspective, women should be informed of the small statistical differences in various risks, then empowered to choose their preferred option.
Peleg et al. (1999)
C
Secondary analysis of TERM PROM study.

Purpose: to identify predictors of cesarean section post PROM at term.
N = 5028.

90.1% delivered vaginally compared to 9.9% delivered by cesarean.

The association between the variables and mode of delivery was tested using x2 univariate analysis. Multivariate analysis was then done by step-wise logistic regression to determine the statistically significant (p<0.05) independent predictors of cesarean delivery.

The strongest predictor of cesarean was country of birth (Sweden < Denmark < United Kingdom < Canada < Australia).

Other strong predictors for cesarean delivery were nulliparity (OR 2.81, 95% CI, 1.95 to 4.05); active labor >12 hours (OR 2.78, 95% CI 2.01 - 3.85), previous cesarean (OR 2.75, 95% CI 1.46 - 5.16), and epidural (OR 2.75, 95% CI 1.94 - 3.65).
Women with PROM were assessed by single sterile vaginal examination for initial diagnosis of PROM. Cervical dilation and effacement were also recorded.

The duration of PROM and/or mode of PROM management were not associated with increased cesarean section rates, according to this secondary analysis.

However, nulliparity and active labor >12 hours were found to have higher cesarean section rates. Therefore, women with less ripe cervices may need longer durations of labor for vaginal delivery to occur.

Variations in the rates of cesarean deliveries were most affected by country. Different settings and environmental factors, then, were shown to impact this birth outcome.

Midwives offering lower intervention care in the home setting may provide a PROM management option that reduces cesarean section rates without increasing infection risk.

Table 6: EVIDENCE TABLE OF PROSPECTIVE PROM STUDIES
Study
authors
Grade of Evidence
A=true
experiment
B= quasi-
experiment
C= correlation
D= description
Study design

Sample size and descriptionResearch procedureMeasures used & their reliability & validityStatistics reported
(include type of statistic reported & p value/confidence intervals as indicated)
Study results & midwifery perspective
Alcalay et al (1996)
A
Prospective randomized trialN = 154 women with PROM at term.

Expectant management (EM) = 80

Oxytocin induction (OI) = 74
Patients with term PROM > 36 wks gestation were randomly assigned to one of the two groups. Sterile speculum exam was used to diagnose PROM, then no further invasive procedures were performed. Preexisting infection was ruled out on admission to the study through amniotic fluid and blood cultures, and temperature monitoring. The study was conducted in the antepartum ward of an European hospital.

Daily monitoring included: WBC, oral & rectal temps, and BPP. Full sepsis workup was performed on neonates with suspected infection, and for those with PROM >48 hours.
Method used included two-tailed Student's t-test and x2testing. P-value of <0.05 was considered significant. Reliability & validity were met.


Mean duration of PROM to delivery: EM group = 27.9H, OI group =14.3 H, P <0.01.

Spontaneous vaginal delivery:
EM = 93.7%, OI = 79.7%, P <0.05.

Fetal distress: EM = 2.5%, OI = 9.5%, P <0.07.

C-section: EM 2.5%, OI 4.1%, P NS.

Chorioamnionitis: EM 2.5%, OI 5.4%, P NS

Neonatal sepsis
(confirmed by culture): EM 1.25%, OI 1.35%, P NS.
The mean period from PROM to delivery was shorter for the induced group. The mean duration of labor was significantly shorter for the expectantly managed group. One infant in each group experienced clinical evidence of infection, with both recovering fully.

This study shows evidence that expectant management of term PROM is safe.
Hannah et al (2000)
A
Secondary analysis of the TERM PROM study. N = 653 managed partially or completely at home, after initial evaluation in hospital.

N = 1017 managed in hospital.
This study did not accurately investigate home management because all subjects received invasive digital examinations in the hospital prior to entry into the study. Some were admitted, then later discharged to home care. Single diagnostic sterile speculum examination in the home along with midwifery home management would prevent patient exposure to such invasive monitoring and potentially more virulent hospital microbes.Multiple logistic regression analysis was used to determine whether adverse effects of expectant management for PROM at term and patient satisfaction were greater in those managed at home.

Reliability and validity were met.
Chorioamnionitis: 10.1% home compared to 6.4% hospital (P=0.006).

Neonatal infection: 3.1% home vs 1.7% hospital (OR 1.97, CI 95% 1.00-3.90, P = 0.05).
Authors conclude that home management of PROM may increase the likelihood of some adverse outcomes, while leading to reduced levels of patient satisfaction.
Hanna et al (1996)
A
Prospective, multi-center randomized controlled trial.N = 5041 women with term PROM were assigned to one of four groups: Induction with IV oxytocin, induction with PGE2, expectant management up to 4 days followed by induction by one of the above.Subjects were recruited from 72 centers internationally. Each was randomly assigned via centralized telephone randomization program. Labor management and monitoring varied according to site, practitioner, and subject allocation. Clinical chorioamnionitis was defined as maternal temperature > 37.5C on two or more occasions, a single temp >38C, or a maternal WBC > 20,000 cells/mm3.

Multiple logistic regression analysis was once again used. Reliability and validity were established.
Outcomes for the groups were similar:

Neonatal infection: Induction-Oxytocin group = 2%, induction-PGE2 = 3.0%, exp mgmt (oxytocin) = 2.8%, exp mgmt (PGE2) = 2.7%.

Chorioamnionitis induction-oxytocin to exp mgmt (oxytocin): 4.0% vs 8.6%, P<0.001.
Women with PROM in this study appeared to have lower risk for infection when induced, as compared to expectant management. The author recommends induction. Women were also reported to have reduced satisfaction when managed at home, possibly due to the requirement for frequent trips to the hospital for testing.

Expectant management with midwives may reduce patient risk and dissatisfaction in a home birth population due to the opportunity for 100% home care.
Hannah et al (1997)
A
Secondary analysis or TERM PROM study. N = 516 total GBS positive women.

N = 121 induced with oxytocin
N = 133 induced with PGE2
N = 149 expectant, then oxytocin
N = 115 expectant, then PGE2.
The rates of maternal antibiotic use, clinical chorioamnionitis, neonatal infection, neonatal antibiotic use, and NICU admission were compared for each of 4 groups.
Multiple logistic regression analysis was used to determine the effect of induction of labor on neonatal infection in GBS + women with PROM.When treatment groups were combined to assess for neonatal infection, the odds ratio was 3.08 (p <0.001) for the induction-oxytocin and expectant-oxytocin groups, 3.31 (p <0.001 for induction-oxytocin and induction PGE2 groups, and 4.45 (P < 0.001) for the induction-PGE2 and expectant-PGE2 groups.GBS status was predictive of neonatal infection for those induced with PGE2 and for those in the expectant management groups. No increase in GBS infection was seen with the oxytocin induced group.

The duration of membrane rupture was not a significant predictor of neonatal infection.
Kappy et al (1982)


A
Prospective controlled trial

.
N = 150 hospitalized women with PROM >36 wks gestation.

N = 112 expectant management group

N = 28 early induction group
Diagnosis made through sterile speculum examination. No SVE allowed. Women with Bishops > 8 were offered induction by oxytocin. All others were managed expectantly until labor ensued or signs of infection developed.
All clients managed expectantly had a daily CBC with diff, temp a4H, daily evaluation of uterine tenderness and daily NST. Clients with signs of chorioamnionitis were treated with IV antibiotics, followed by oxytocin induction.At delivery, all neonates received appropriate bacterial cultures. Microscopic evaluation of placentas were done for those with suspected chorioamnionitis.Duration of expectant management was not time limited. Spontaneous labor: 87% within 48 hours, 3.6% went between 7 and 18 days.

Cesarean rate: 39% for induction group vs 12% for expectant mgmt group (P = < 0.01).

No cases of culture positive sepsis, even for those with 7-18 day PROM.

No maternal or neonatal deaths.
Extended time periods for the expectant management of term PROM with an unfavorable cervix is safe and may reduce the incidence of cesarean section without an increase in infection.
Keirse et al (1996)
D
Meta-analysis of controlled trials.
Inclusion criteria: Trials were limited to random controlled studies that took place over the same period of time.
N = 2441 subjects from a total of 15 studies.Meta-analysisReliability and validity were established.Data show a 30% increase in cesarean section rate for PROM with active induction compared with expectant mgmt (OR 1.3, 95% CI).

Data for infectious morbidity within the expectant management groups ranged from 0-28% for maternal and from 0-16% for neonatal.

Neonatal infectious morbidity did occur less frequently in the active group (N=3/843) than in the expectant groups (N=11/805) (OR 0.37, 95 CI: 0.19 to 0.73).
The studies examined reveal a lack of consistent methodology, wide variations in diagnostic criteria, and large differences in the allotted time limits for expectant management.

There is a high potential for bias within the studies examined because clinical diagnosis of infection was usually made by persons who knew the type of management option applied. Therefore, more cultures may have been collected on neonates with longer durations of PROM, resulting in higher rates of diagnosis.

Overall, the data shows little difference in maternal morbidity between active and expectant management policies. An expectant policy may increase the risk of neonatal morbidity, but the effect (if any) is small and may be impacted by observer bias. PROM by itself should not be an indication for induction. Mothers should be offered a choice among the options.
Kenyon et al (2001)
A
Randomized, blinded, multicenter trialN = 4826 women with PPROM <37 weeks gestation.

Women were randomly assigned to one of four treatment groups:
  • 325 mg Augmentin plus 250 mg erythromycin
  • 325 mg Augmentin plus erythromycin placebo
  • 250 mg Erythromycin plus Augmentin placebo
  • Two placebo
Participants took the trial medicine orally, QID x 10 days or until delivery.

Group assignment was randomly selected by computer, and blinded by sequential numbering system.

Data were collected three times using entry forms and outcome forms: At entry into study, at discharge of the mother after delivery, and at death or discharge of the baby. Endpoint for data collection was hospital discharge.
All data were entered and verified by two people on two separate occasions. Random samples of pediatric data (10%) were checked against source documentation for accuracy.

Statistical analysis was done by use of the Ztest; two-sided p-values were cited throughout. Unpaired ttest was used for normal distributions; Mann-Whitney test otherwise.

Reliability and validity were well established.
There were statistically significant differences between the erythromycin only group & placebo group in regard to positive blood cultures (5.3% vs 7.4%, p = 0.03). No differences in necrotising enterocolitis (NEC) were found.

For Augmentin group: positive blood cultures = 6.8%. NEC = 4.1% vs 2.7% placebo only (p=0.08).

Combined antibiotics: positive cultures = 7.0%, p =0.27. NEC = 3.5%, p=0.23.

There were no appreciable differences for maternal outcomes.
Oral erythromycin alone may reduce the incidence of neonatal infection in PPROM without an increase in necrotizing enterocolitis.

Use of oral Augmentin increases necrotizing enterocolitis without a significant decrease in rates of PROM neonatal sepsis.

For midwives, use of oral erythromycin for home management of PROM may offer some benefit. But, additional study is first needed in order to verify results of this ORACLE trial.
Ladfors et al (1996)
A
Prospective, randomized controlled trialN = 1385 women with PROM between 34 and 42 weeks.

N = 502 to early induction group.

N = 510 to late induction group.
Women were randomized to early induction at 24 hours or late induction at 72 hours after PROM. Digital examinations were avoided until onset of active labor. All labors experienced internal fetal scalp monitoring.

Labor was induced with oxytocin if no spontaneous contractions occurred at the end of the allotted time period, or if signs of chorioamnionitis or fetal distress were detected.
Outcome data tested for included: frequency of spontaneous deliveries, operative deliveries, maternal and neonatal infection, and Apgar scores.

Data were analyzed using Duncan's multiple range test or Tukey's studentised range test HSD. A P-value of < 0.05 was considered significant.

Data were further analyzed for nullipara and multipara sub groups.
80% had spontaneous contractions within 26 hours of PROM. After 50 hours, only 10% were still awaiting labor.

Chorioamnionitis was diagnosed in 2 women with early induction and 4 women with late induction (0.8% overall). There were no differences in the rates of neonatal infection among the groups.
Expectant management for up to 72 hours offers benefit of reduced cesarean section rates without a statistically significant rise in maternal or neonatal infection, especially for nulliparous women.
McCaul et al, 1997)
A
Prospective, randomized, controlled trialN = 96 women with PROM and an unfavorable cervix between 36-42 weeks gestation.

Three treatment groups:

N = 25 PGE2 induction

N = 35 oxytocin induction

N = 31 expectant management
On admission to hospital, PROM was diagnosed by microscopic examination of pooling of amniotic fluid. Fetal monitoring was used to exclude persistent uterine activity and/or fetal distress.

Inclusion criteria: women aged 16-35 years, cervical dilation < 3cm, effacement < 75% determined by SVE, cephalic singleton fetus, PROM < 24 hours duration.

Random selection was via computer. Daily NST and AFI were used to monitor the expectant group.
Chi-square, Fisher's Exact Test, and ANOVA were used in statistical analysis A P value of < 0.05 was considered significant.

Sample size was small. Reliability was well established, but validity is questionable.
Study results showed no differences in neonatal infection, maternal febrile morbidity, or in cesarean section. There was a 13% incidence of variable decelerations in the expectant management group, but no associated adverse outcomes. This study failed to establish PGE2 as superior to oxytocin induction. The authors demonstrated bias through via their interpretation of isolated EFM data. The authors felt that evidence of variable decelerations signifies increased risk of cord accident for the expectant management group. Longer hospital stays during the latency period were also identified as potential client deterrents, without evidence of such.

Expectant management was not shown to increase morbidity or mortality rates. Concern about client satisfaction provides rationale for home expectant management with midwives.
Naef et al (1998)
A
Prospective randomized controlled trialN = 120 women between 34 and 36 6/chorioamnionitis.

N = 57 immediate induction with oxytocin

N = 63 expectant management
Sterile speculum examination was used to confirm pooled amniotic fluid, along with microscopic confirmation. No SVE were performed.

Blinded computer-generated random assignment was utilized. Patients were monitored by continuous EFM for 2-4 hours, then those in the expectant management group were transferred to the antepartum unit and monitored every 8 hours. GBS prophylaxis was done for all GBS positive patients.

The active management group received oxytocin IV until active labor was established.

Neonatologists were not blinded to perinatal clinical course.
Outcomes measured included: chorioamnionitis, type of delivery, birth weight, Apgar scores, RDS, NICU admission, and sepsis.

Statistical analysis of group differences was done through use of the x2 test and Fisher's exact test for discrete data; and the Student t test for continuous data. P < 0.05 was accepted as significant.

Reliability was established. The small sample size threatens applicability of findings.
Chorioamnionitis was higher for those managed expectantly (16% vs 2%, p - 0.007).

Neonatal sepsis was slightly more common in the expectant management group (0% vs 5%, p = 0.151). All recovered completely.

Cesarean section was slightly lower in the expectant management group (7% vs 5%, p = 0.444)).

There were no other significant differences in outcome measures.
The authors recommend active induction of PROM labor due to this study's finding of higher chorioamnionitis in the expectant management group. However, the study's percentage of difference does not concur with the rates found in previous studies, perhaps due to overdiagnosis and small sample size used. This study cannot be used as justification for immediate induction.
Seaward et al. (1997)
A
Secondary analysis of TERM PROM study to determine predictors of clinical chorioamnionitis.
N = 5028.

Spontaneous labor occurred in 2225 (44%).

Internal fetal monitoring was used in 1541 (30%) of patients.
Univariate analysis and multivariate analysis were used. X2and Fisher's exact test were used to test categoric data. Student's ttest was used for data not normally distributed. Logical regression analysis was performed. All p values were based on two-tailed tests with p<0.05 identified as statistically significant.Variables found to be associated with chorioamnionitis include: number of digital vaginal examinations >8, 7 to 8, 5 to 6, 3 to 4, (OR 5.07, 3.80, 2.62, 2.06); duration of labor >12, 9 to < 12, 6 to < 9, (OR 4.12,2.94,1.97); meconium-stained fluid (OR 2.28); parity of 0 (OR 1.80); time frame from PROM to active labor >48, 24 to <48 (OR 1.76, 1.77); and GBS colonization (OR 1.71).This study demonstrates that vaginal examinations lead to significant increases in the rates of chorioamnionitis.

The authors claimed the IFM was not associated with chorioamnionitis, but no specific data showing multiple logistic regression analysis for this variable were included in the report. With 30% of women exposed to IFM, the impact of this invasive procedure needs to be further addressed.

Avoidance of vaginally invasive iatrogenic procedures seems prudent in light of these findings. Midwives providing expectant management of PROM in the home setting may be the best option, since home midwifery care is known for reduced rates of intervention.
Ottervanger et al. (1996)
A
Prospective, randomized controlled trialN = 123 hospitalized women with PROM between 37 and 42 weeks gestation.

N = 62 expectant management up to 48 hours

N = 61 immediate oxytocin induction
Women presenting to the hospital with PROM were randomly assigned to one of the two study groups. PROM was diagnosed by history, loss of fluid and occasionally sterile speculum exam. Cervical swabs were taken at first vaginal examination. Cultures were taken from the baby at delivery, and a cord section was sent for pathological examination.

Those in expectant care were monitored with EFM, daily WBC, temp qid. Ambulation was not restricted. After 48 hours with no labor, IV oxytocin induction was offered.
Randomization was conducted in blocks of 20 with an interim analysis after 120 patients had been entered. Outcome measures reviewed included: cesarean section, operative delivery, use of analgesia, infectious morbidity of mother and/or newborn, and infant hospitalization after discharge.

Women were excluded if they presented with obstetrical problems such as infection, abnormal FHT, or HTN. Random assignment was performed by means of sealed envelopes.

Reliability and validity were met.
Fifty-eight (one-sided) to 71 (two-sided) women were required per group to demonstrate statistical significance (p<0.05) with a power of 0.08.

55% went into spontaneous labor within 24 hours, an additional 16% within the next 24 hours, for a total of 81% by study endpoint.

Cesarean sections: 15.0% induction group vs 5.2% expectant management group.

Instrumental delivery: 16.4% induced vs 6.4% exp mgmt (OR 9.9 95% CI -1.2 to 21.1).

Positive initial cervical cultures (timing unspecified): 15 induced vs 16 exp mgmt.

Maternal clinical infection: 1.6% induced vs 3.2% exp mgmt (OR -1.6, 95% CI -7.0 to 3.8).

Positive culture of gastric aspirate = 37, but none showed clinical sepsis.
No differences were found in the rate of infectious morbidity, use of antibiotics, or positive cervical cultures.

Expectant management for up to 48 hours can decrease cesarean rates without increasing infectious morbidity.

Further study is needed using longer durations of expectant management to determine maximal duration of benefit.
Shalev et al (1995)
A
Prospective, controlled trialN = 566 women with PROM between 37 and 42 weeks.PROM was confirmed by a single sterile speculum examination and nitrazine testing. Existing infection was ruled out through blood and amniotic fluid cultures. No vaginal examinations were permitted.

Women were assigned to either a 12-hour or 72-hour expectant management plan. All women were placed on bedrest during this time. After the designated time period, women not in labor were induced with IV oxytocin. At birth, cultures were taken from the fetal membranes, placenta, and newborn oral cavity.
Results were analyzed using x2 and Yates correction and Student t test methods.

Reliability and validity were met.
83% in the 72-hour group entered spontaneous labor, compared to 43% in the 12-hour group.

There were no significant differences in the number of uterine infections or in the number of cesarean sections.

There were no differences in neonatal Apgar scoring or in rates of neonatal sepsis.
72-hour periods of expectant management for PROM can produce higher rates of spontaneous labor without increasing infectious morbidity or mortality. Women may be more comfortable during this time in their own homes.
Sperling et al. (1993)
A
Prospective randomized controlled trialN = 362 women with PROM > 36 weeks were invited into the study.

N = 62 induced at 6 hours after PROM

N = 62 induced after 24 hours of PROM

238 declined participation due to desire for autonomy over management option and/or desire for "natural birth."
PROM was confined by history and by midwife performed SVE. WBC and mid-stream urine culture were taken at admission to study.

Women were randomized to one of two IV oxytocin induction groups: Early induction at 6 H after PROM or later induction at 24 H after PROM. Pulse, temp and FHT were recorded every 6 hours. Labor monitoring was performed by IFM. Vaginal examinations were allowed, but minimized until active labor. After delivery, the placenta and membranes were sent to pathology. Newborns skin cultures were taken for PROM > 24 H.
Statistical analysis used the Mann-Whitney U-test for variables in labor, and the Chi-square-test (x2, two-tailed) was used for frequency of obstetrical interventions.
Jonckheere-Terpstra Test was used to evaluate rates of chorioamnionitis in relation to duration of PROM and length of labor.

P < 0.05 was identified as statistically significance.
N participants = 124.

40% entered spontaneous labor within 12 hours. 68% entered spontaneous labor within 24 hours.

Two primiparas developed chorioamnionitis at 14.7 hours and 18.9 hours respectively. One of the newborns was treated with antibiotics for fever and tachypnea, but cultures were negative.

Spontaneous vaginal delivery occurred for 71% in the early induction group and 69% in the late induction group.

Cesarean sections rates: 10% in the early induction group (all primiparous) and 13% in the late induction group (OR 0.72. 95% CI 0.33 to 1.60, p < 0.05).

Intrapartum infection: 0% early induction, 3% late induction (all primiparous).

None of the newborns had positive cultures.
The authors concluded that increasing time spans from PROM to delivery lead to increased maternal infection. However, the study sample and time frame are too small to justify such a conclusion. Furthermore, invasive vaginal examinations and internal fetal monitoring were universally applied. These two practices have been shown in later studies to increase infection rates due to ascending bacteria. The increase found in this study is likely iatrogenic.

This study shows that invasive monitoring procedures may increase the rates of PROM related infection, and are thus preventable.
Theunissen & Van Lierde (1989)
B
Prospective quasi-experimental designN = 215 women with PROM between 24 and 36 weeks gestation.

Each neonate born after PROM was compared with a premature neonate matched for the same birth age and year of birth.

Statistical analysis was done using Chi-square tests of independence.
PROM was diagnosed via history and sterile speculum examination with microscopic examination of pooled fluid for ferning. GBS cultures, US, and EFM were done on admission. Women were confined to bed rest in hospital. The treatment group received IV ampicillin or erythromycin and tocolysis.

Maternal temperature, eval of uterine tenderness, EFM bid, CBC with diff qod, and weekly cervical cultures were utilized.
Outcome measurements included: gestational age at birth, birth weight, Apgar scores, neonatal infection. and neonatal death by age 1 week.

Neonatal infection was diagnosed by central culture (blood, urine, CSF).
Neonatal infection after maternal chorioamnionitis: 23.7%; after absence of chorioamnionitis: 5.6% (p < 0.0001).
This study found no relationship between the latency period and rates of chorioamnionitis or neonatal infection. Even prolonged latency > 7 days did not increase the risk of chorioamnionitis or neonatal sepsis.

Clinical suspicion of chorioamnionitis does increase the risk of neonatal infection.

Therefore, midwives finding no clinical evidence of chorioamnionitis can safely continue expectant management, even > 7 days after PROM.

C. Criteria established for effectiveness For inclusion in the formation of this evidenced-based clinical practice guideline, only articles reported as research are accepted. Studies are further limited to those with a focus on spontaneous PROM and / or home birth issues. For references to be valuable and applicable to this project, each must reflect higher quality research, such as clinical trials and meta-analyses. The discovery of similar results in other studies is also considered evidence of effectiveness. Home birth risk screening criteria and informed consent can be found in Appendices A and B. For PROM specific protocol and informed consent, see Appendices C and D. D. Clinical perspectives represented

Data collected for this project comes from medical, nursing, nurse-midwifery, and traditional midwifery resources. Sources are also international in scope, originating from several different countries. Articles written by large professional and governmental organizations demonstrate additional interest from researchers and policy developers. The clinical perspective is thus representative of interdisciplinary evidence because data were taken from numerous, diverse cultural and professional perspectives.

Population of interest

Census data for the year 2002 reports that 4,021,726 babies were born in the United States (National Center for Health Statistics, 2002). Of these, an estimated 1%, or 40,217 occur in the home setting (ACNM, 2003). With 5% to 10% of term pregnancies experiencing PROM, approximately 2010 to 4021 American women planning home birth will be affected by PROM management decisions. Home birth attendants, primarily midwives, will also be affected by PROM in clinical practice. At present, the exact number of home birth attendants is not known. No single national system currently exists to track all practice locations for the various types of midwives (CNM, CM, DEM, lay). Practices are also fluid and the total number of providers in the home setting is constantly changing. Nonetheless, practitioners offering home birth must be prepared for management of PROM.

Decision support

A. Synthesis of evidence/conclusions
  1. The literature indicates that home birth is safe for healthy women.
  2. Women who seek home birth prefer increased autonomy, decreased intervention, freedom of individual expression, nurturing relationships, and a familiar environment for promotion of normal physiological processes.
  3. Midwives offering home birth have risk-screening skills that are advanced and serve to effectively promote safety in home birth.
  4. Midwives offering home birth use fewer interventions, thus avoiding many of the potential side effects and risks that coincide with alteration of normal, healthy birthing processes.
  5. Home birth with skilled midwives leads to fewer cesarean sections, higher birth weights, and lower maternal and neonatal mortality.
  6. With fewer interventions and healthy birth outcomes, home birth is a cost effective means of health care delivery.
  7. Vaginal examinations are correlated with increased rates of chorioamnionitis, endometritis, and neonatal sepsis.
  8. Although PROM occurs in 5% to 10% of term pregnancies, the actual risk of infectious maternal and/or neonatal morbidity for healthy women remain low (1%-3%), as long as vaginal examinations are avoided.
  9. Expectant management of PROM for at least 72 hours leads to fewer cesarean sections, fewer operative deliveries, and without increasing infection or mortality rates.
  10. Expectant management of PROM for longer than 72 hours might also be safe in environments where vaginal examinations are avoided. Additional study is needed in order to determine the maximal safe duration for this type of expectant management.

B. Summary statement of findings

Five to ten percent of all term pregnancies will experience premature rupture of membranes. Fewer than 3% of these will develop infectious morbidity as long as invasive monitoring procedures, such as vaginal examinations, are avoided. Rushing to immediate labor induction for PROM unnecessarily interrupts the processes that serve to prepare the body for labor and carries risks that include protracted labor, instrumental delivery, and cesarean section. In the home setting, women are better able to avoid iatrogenic risks and may find comfort in opportunities to continue their normal routines. Watchful waiting in an absence of clinical signs of infection or fetal distress is a safe option for low risk women under certain conditions. Both immediate induction and expectant management options carry potential risks and benefits. Therefore, each woman should be fully informed of the choices available so that she can be free to choose the option that best coincides with her individual health concerns, personal value system and goals. This evidenced-based clinical practical practice guideline is a tool that can guide informed consent and standardize the practice of the expectant management of PROM in home birth.

C. Outline of EB-CPG/clinical algorithm

Does client seek home birth with a midwife?

Does client meet home birth risk screening criteria (see Appendix A) and has she signed the home birth informed consent (see Appendix B)? When client develops PROM at term, does client present without signs of infection, fetal distress, or other complications? After review of the potential risks and benefits, does client consent to home birth expectant management (see Appendix C)? Does client remain free of additional risk factors?
Evaluation/Measurement strategy and re-evaluation plan

The management of PROM has varied among practitioners due to inconsistency within the literature. Until now, studies have primarily been limited to hospitalized populations. Interventions such as vaginal examinations and internal fetal monitoring have increased the rates of complications such as infection. Routine collection of cultures has led to probably overdiagnosis of infection for women and neonates lacking clinical symptoms. The review of the literature suggests that expectant management (as offered by the midwifery model of care) for 72 hours or more can be performed safely with little, if any, increase in clinical infection. Since there have been no specific studies to date on the midwifery management of PROM in home birth, more research is needed. An independent committee will be appointed and charged with the duty of performing chart audits of home birth midwifery clients affected by PROM. Client outcomes will be reviewed at 6 months and 12 months, then compared with outcomes of PROM cases occuring prior to implementation of the new guideline. The following outcome criteria will be considered:
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Appendix A
HOME BIRTH RISK SCREENING FORM

Name________________________DOB/Age____________EDD_____________
Initial Risk Screening (date _____)
Indicates concern / at risk Indicates high risk
___Age <18 or >40 ___Alcohol or drug use in pregnancy
___Asthma, mild and controlled ___Cardiac disease or chronic HTN
___< 1 yr between pregnancies ___Contracted / abnormal pelvis
___Depression, history of or currently mild ___Clotting abnormalities
___Diabetes, history of gestational ___Diabetes melitis
___Hemorrhage - history of mild & easily controlled ___> 3 first trimester SAB, unexplained
___HgB < 11.0 mg/dl before 20 weeks ___Fetal or neonatal death - unexplained
___Onset prenatal care after 20 weeks ___Genetic anomalies in baby, treatable
___Malpresentation at term, history of ___Hepatitis
___Para > 7 deliveries ___HIV
___Partner absent / lack of support ___Isoimmunization
___PIH in previous pregnancy ___Lung disease - uncontrolled or severe
___Previous birth > 4200 gms ___Psychosis or severe psych illness
___Preterm birth / SGA baby, history of ___Refusal to abide by protocols
___Shoulder dystocia, history of ___Renal disease
___STD, history of or current ___TB - active
___Teratogen exposure ___Tobacco use after 1st trimester
___Tobacco use in 1st trimester ___Uterine scar, classical or single closure
___Weight 20% under or over ideal
___ Initial Risk Status
___ ___ No known risk factors: exp mgmt
___ ___ Increased Concern: preventative mgmt
___ ___ High risk list: transfer to hosp provider
___
Continuing evaluation of risk status
Additional concern/ at risk factors Additional high risk factors
___Fatigue, unusual or severe ___Anemia (HgB < 10.0 at 36 wks)
___GBS positive screen ___Bleeding - abnormal & unexplained
___Glucose intolerance ___Cessation of signs of fetal life
___Incompatibility of client & midwife ___Congenital anomaly - known
___Malpresentation after 34 wks ___GDM, insulin dependent
___Term > 41 1/2 weeks ___Herpes - active lesion at term
___PROM ___IUGR
___Varicella exposure, if not immune ___Malpresentation in labor
___Weight- inadequate gain or loss ___Multiple gestation
___ ___Oligo / polyhydramnios
___ ___PIH or preeclampsia
___ ___Placenta previa or abruption
___ ___Postdates >42 completed wks
___ ___PTL or SROM before 37 wks
___Rh sensitization

Re-evaluation of risk at 36 weeks & PRN
Appendix B
STATEMENT OF INFORMED DISCLOSURE FOR HOME BIRTH

Parents have the right and responsibility to be fully informed regarding prospective health care choices. This statement is intended to provide you with information to assist in your birth planning. These decisions are not to be taken lightly. In the state of Iowa, your choices for birth care providers include obstetricians, family practice doctors, certified nurse-midwives, and non-licensed traditional midwives. Each has a specific orientation towards birth. Educate yourselves, ask questions, and evaluate your environment for safety. Explore all of your options so that your choices will be right for you.
Philosophy of BIRTH MATTERS Midwifery Service
We believe that childbirth is a normal life event which, for healthy women, will proceed to an uncomplicated end in most cases. The home birth midwife’s job is to assist the birthing couple in this journey through education, monitoring of normal progress, provision of supportive comfort measures, and through use of midwifery interventions when clinically indicated. Cases involving complications that are outside of the midwife's scope of practice will be referred to the consulting physician.
We also believe that childbirth is a family centered event, and that the midwife’s role is to enhance - not to usurp - the family’s power of unity. Except where there is an issue concerning the safety of the mother or child, we believe that the parents should have the experiences they desire.
We believe that clients must maintain full responsibility for their own health care and for the outcome of the birth. This requires review of all options, superior nutrition, and complete honesty with your health care providers. You must assume the responsibility of maintaining your own excellent health regardless of your chosen location of birth. Home birth clients must take extra responsibility in this area since advanced technological help is not immediately available, as it is for those birthing in the hospital.
Education and Responsibility of Midwife
BIRTH MATTERS Midwifery Service has been established as a private practice, owned and operated by Susan Karimi, ARNP, CNM. Susan is the primary midwife for this practice, attending each birth along with a specially trained birth assistant. Susan’s education includes: certification as a Bradley childbirth educator (1991), accreditation as a La Leche League leader (1991), two years study as a traditional home birth midwife (1991-1993), and graduate of a four year BSN nursing program (1997). Following college, Susan earned her advanced degree in Nurse - Midwifery (2000). All members of the BIRTH MATTERS team maintain certification in CPR and neonatal resuscitation.
As a nurse-midwife, Susan is licensed to:
Services that are not provided include:
As your midwife, Susan Karimi agrees to:
SCREENING AND TRANSFER OF CARE

Natural pregnancy and birth, for healthy women, occurs without complication most of the time. For approximately 12% of first-time mothers and 7% of mothers having repeat births, a condition may occur that is outside of the scope of this home birth midwifery practice. Please be prepared to transfer to a hospital-based practitioner if you develop any of the following conditions. After transfer of care, the hospital-based practitioner...not Susan Karimi, ARNP/CNM...will provide for your health services. Susan will continue to offer emotional support, comfort, advocacy and information.

PREGNANCY
Anemia at term, abnormal bleeding, blood clotting disorders, persistent breech or malpresentation, unresolved high blood pressure, cancer, gestational or insulin dependent diabetes, fetal death, heart disease, hepatitis, kidney disease, psychiatric problems, dishonesty, smoking, alcohol or street drug use, premature labor, prolonged rupture of membranes with demonstrated pathology, prolonged rupture of membranes > 72 hours, fetal growth retardation, Rh or ABO sensitization, client refusal to follow midwifery guidelines, incompatibility between client and midwife, postdates after 42 weeks with proven fetal compromise, multiple gestation (twins etc), or any other condition that the midwife feels indicates a need for physician care.

LABOR & BIRTH
Abnormal bleeding, abnormal fetal heart pattern, active herpes outbreak at start of labor, thick meconium stained fluid, fever over 100.4F, prolonged rupture of membranes > 72 hours, maternal exhaustion or dehydration, prolonged active labor, suspected uterine rupture, estimated fetal weight less than 6 pounds, delayed placenta, or any other condition that the midwife feels indicates need for physician care.

IMMEDIATE POSTPARTUM (birth to 4 hours)
Breathing problems, birth defect or injury in baby, continued bleeding problems in mother, cardiac arrest or shock, high blood pressure, Apgar <7 at 5 minutes of age, unresolved low blood sugar, incomplete delivery of placenta & membranes, fever over 100.4F, perineal tears beyond midwife's ability to suture, or any other condition that the midwife feels indicates need for physician care.

POSTPARTUM ( 4 hours to 6 weeks)
Unresolved feeding problems, unresolved infection, birth defect in baby, jaundice in baby before 24 hours of age or excessive jaundice after 24 hours of age, signs of blood clots, convulsions, unresolved high pitch cry in baby, inadequate weight gain of baby, postpartum depression or psychosis, or any other condition that the midwife feels indicates need for physician care.

Philosophy and Responsibility of Parents
I/We, the parent(s), have chosen to plan for a home birth with BIRTH MATTERS Midwifery Service, based upon what we believe to be a thorough examination of the options. We have discussed the options between ourselves, and with physicians, certified nurse-midwives, and other knowledgeable people to the extent we think necessary. After considering these options, we have decided to plan for a home birth.
I/We have gone over the information on this 4 page Statement of Informed Disclosure, and have discussed the experiences and services of Susan Karimi, ARNP, CNM.
In addition to the statements outlined above, we also fully understand and agree to the following:
  1. The midwife is licensed as a nurse-midwife by the state of Iowa. The midwife is not a doctor.
  2. We realize that it is impossible at a home birth to provide the same type of care that is available in the hospital. In a hospital, there would be more attendants, high-tech monitoring devices, medications, blood products, and surgical facilities. We are fully aware that in the event of complications or an emergency there are fewer technological resources available at a home birth.
  3. We believe that birth is a generally safe process for healthy women. We have, however, discussed some of the potential problems which can arise in childbirth such as: birth defects, bleeding or breathing problems, cerebral palsy, cord accidents, infection, malpresentation, meconium, placenta problems, prolapsed cord, toxemia, shoulder dystocia, and stillbirth. We accept responsibility for the outcome of the pregnancy/birth, and agree to release and hold harmless Susan Karimi, ARNP/CNM and BIRTH MATTERS for less than perfect results.
  4. We understand that the midwife cannot guarantee her attendance at our home for the birth. An unusually fast labor, bad weather, or traffic delays could prevent the midwife from arriving in time. We agree to call the midwife immediately when labor is suspected. If birth appears imminent, we will notify the midwife and seek immediate care from the nearest available resource.
  5. If we or the midwife feel that complications are developing at any time, we agree to transfer to the consulting physician or hospital for medical care. We have been informed that we may decide against home birth at any time.
  6. We agree to accept financial responsibility for any and all debts to BIRTH MATTERS, doctors, nurse-midwives, other health care providers, clinics, laboratories, and hospitals for care delivered to us.

I/We, the parent(s), have read the above information and agree to accept the risks and responsibilities of home birth.

______________________________ _______________________________
mother date father date
Appendix C
INFORMED CONSENT FOR PREMATURE RUPTURE OF MEMBRANES

What is premature rupture of membranes (PROM)?
PROM occurs when the sac of water surrounding your baby breaks and the amniotic fluid leaks out. PROM affects approximately 5% to 10% of pregnancies that are between 37 and 42 weeks gestation. These pregnancies are considered full-term.

Are the waters really gone?
Your body continues to produce fresh amniotic fluid 24 hours a day. PROM can release a slow trickle of the waters, or may result in a large gush of fluid from your vagina.

How is PROM diagnosed?
If you think your waters have broken, pay attention to the color and amount. Then, call your midwife. The midwife will need to perform a gentle vaginal examination with a sterile speculum. A sample of any pooled fluid will be collected with a cotton swab, tested with a special paper and viewed under a microscope. A blood test and urine sample may also be collected to rule out infection.

What are the risks of PROM?
Infection is the main risk of PROM. When the amniotic sac is sealed, it protects your uterus and baby from environmental bacteria. Now that the bag is broken, bacteria can work their way from the lower genital tract into your womb, causing infection around the baby.

Other, less common, risks include cord problems or abnormal positioning of the baby (like breech position). Your midwife will feel the baby's position to make sure he or she is head down. An ultrasound examination may also be done to confirm the baby's position. The midwife will need to listen to your baby's heart more frequently to make sure that the cord is also functioning well.

How long will it take for labor to start naturally?
After PROM, approximately 70% of women will enter labor within 24 hours. By 72 hours, 80% to 90% of be in labor.

What are my options?
As long as there is no sign of infection or problems with the baby, you may choose between immediate induction of labor in the hospital, wait for nature to start labor (known as expectant management), or choose natural methods to encourage labor at home. Each option carries different risks and benefits. These are summarized below:

INDUCTION
EXPECTANT
MANAGEMENT
NATURAL ENCOURAGEMENT
Risks include: Failed induction if the cervix does not respond. This can lead to increased risks of vacuum or forceps delivery OR increased cesarean section.Risks include: No statistically significant increase in infection for the first 3 days, as long as no vaginal penetration (examinations, intercourse, etc) is done. There is also a very small risk for cord problems, prolapsed cord, or poor positioning of the fetus.Risks include: Castor oil causes diarrhea and can be uncomfortable. Herbs and homeopathic medicines may stimulate contraction similar that feel similar to natural labor. There are no known risks to the baby as long as proper dosing is followed.
Benefits include: Lowest risk (1%) for infection as long as minimal or no vaginal examinations are performed.Benefits include: Less intervention means less side effects from drugs or surgery. Home birth is still possible as long as no signs of infection or other problems occur.Benefits include: Labor may start in a more natural way, especially if your body is ready to respond. You avoid the more intense side effects of drug induced labor. If natural encouragement does not work within 4 hours, the option can be stopped to give you adequate rest.

What happens if labor does not start?
If you choose induction, you will be admitted to the hospital under the care of a hospital provider (usually a doctor). If hospital induction does not work, you will be offered cesarean section.

If you choose expectant management and/or natural encouragement at home, you will be monitored daily by your midwife. You will need to take your temperature every 4 hours while you are normally awake, and drink plenty of fluids. If labor is not established within 72 hours, or if you develop any signs of infection or other problems, you will be transferred to the hospital for medical (physician) care.

Please consider your options carefully. Indicate your desired option below.

I/We, the parent(s), have read the above information and choose ___________________________ for the management of premature rupture of membranes. I/We agree to accept the risks and responsibilities for our choice.

______________________________________________________________
mother date father date
Appendix D
PROTOCOL FOR MANAGEMENT OF PROM IN HOME BIRTH

PROM:
  1. H&P with one sterile speculum exam to confirm diagnosis. No digital vaginal examinations.
  2. Tests may include but are not limited to: CBC, UA, fern test, nitrazine test, GBS cultures, STD cultures, NST, ultrasound or BPP. For abnormal test results, refer to applicable practice guideline.
  3. Discuss risks and benefits of expectant management, natural labor encouragement, and medical induction in hospital.

Expectant management:
  1. Temp and pulse every 4 hours while awake. Client to call immediately if T or P increases.
  2. Client to remain at home.
  3. Pelvic rest. Absolutely no vaginal penetration or vaginal examination.
  4. Teach client to maintain pelvic hygiene (hand washing, proper toileting, etc).
  5. NST or AAT testing every 24 hours.
  6. Consider additional laboratory tests and/or ultrasound as indicated.
  7. Maintain adequate hydration.
  8. Encourage diversional activities, laughter, adequate rest, and emotional support.
  9. Consult physician if surveillance testing shows evidence of developing abnormality OR if client is not delivered by 72 hours post-PROM.

Natural Labor Encouragement:
includes the expectant management guideline PLUS one or more of the following:
  1. Castor oil, 2 oz po in orange juice or root beer. May repeat X 1 after four hours.
  2. Homeopathic Caulophyllum 200 C SL and/or Cimicifuga 200C SL. May repeat hourly up to 4 hours.
  3. Blue cohosh tincture and / or black cohosh tincture with continuous midwife surveillance. May administer up to 4 hours. Titrate dose per clinical response.
  4. Nipple stimulation with continuous midwife surveillance, up to 4 hours if stable.
  5. Ambulation.
  6. Balance rest / activity.
  7. Consult physician as indicated.
. . . . . . .