Pitocin or Oral Misoprostol for PROM IOL

Study Overview
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Brief Summary
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Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is not known, particularly among specific subpopulations. The primary aim of this study is to determine if oxytocin (Pitocin) or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with term PROM.

Detailed Description
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Premature rupture of membranes (PROM) occurs in approximately 8% of pregnancies at term.1 Although onset of spontaneous labor is often prompt after membrane rupture, a delay from PROM to labor is associated with an increased risk of intrauterine infection and its associated maternal and fetal complications. For this reason, ACOG endorses induction of labor for PROM if spontaneous labor does not occur near the time of presentation. The optimal method for PROM induction is less clear. Prior literature has examined the use of Pitocin (Oxytocin), vaginal and oral misoprostol, and dinoprost with mixed results. The TermPROM study found an increased risk of chorioamnionitis and NICU admission among women treated with vaginal misoprostol for induction. The postulated link between vaginal misoprostol and chorioamnionitis is the need for vaginal examination for placement of the misoprostol; more vaginal examinations could potentially increase the risk for infection. Utilizing oral misoprostol would eliminate the need for a vaginal exam for administration, thereby potentially mitigating this risk of infection. Currently, vaginal and oral misoprostol as well as oxytocin are used routinely in clinical care based on provider discretion. Among 7 randomized controlled trials examining the use of oral misoprostol as compared to oxytocin, two found oral misoprostol to result in faster induction to delivery, two found oxytocin to result in faster deliveries, and the remaining three found no difference between the two.3-9 These studies are limited by small sample size, inadequate reporting of patient demographics, varied misoprostol and oxytocin protocols, and inconsistent primary outcomes. Therefore, the utility of oral misoprostol in this population has not been established. Furthermore, its efficacy in specific patient populations is unreported in the literature. The primary aim of this study is to determine if oxytocin or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with PROM.

Official Title
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POM PROM: Pitocin or Oral Misoprostol for PROM IOL in Nulliparous Women With Unfavorable Cervical Exams

Conditions
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PROM

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English Speaking PROM </= 24 hours with no evidence of labor >/= 36 weeks gestation Agreeable to induction of labor Nulliparous Singleton pregnancy Vertex presentation Cervical dilation </=2 cm AND Bishop score < 8 Exclusion Criteria: Prior cesarean section Other contraindication to vaginal delivery Intrauterine Fetal Demise Major Congenital Anomaly Intraamniotic infection diagnosed at time of admission 36 weeks - 36 weeks and 6 days with unknown GBS status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Misoprostol<br>Oral misoprostol 50 mcg q4H for up to 6 doses or until cervical ripening is no longer indicated | Drug: Misoprostol<br>* As above<br>|
| Active Comparator: Oxytocin<br>IV Oxytocin 2mU/min, increased by 2mU/min q15 minutes per hospital protocol | Drug: Oxytocin<br>* As above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from IOL to delivery | Time (hours) from start of IOL to delivery | Enrollment to Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Suspected intraamniotic infection | Enrollment to Delivery | 
| Time from PROM to delivery | Time (hours) from PROM to delivery | Enrollment to Delivery | 
| Time from IOL to vaginal delivery | Time (hours) from PROM to delivery | Enrollment to Delivery | 
| Time from PROM to vaginal delivery | Time (hours) from PROM to vaginal delivery | Enrollment to Delivery | 
| Cesarean delivery | Cesarean section rate | Enrollment to Delivery | 
| Maternal morbidity | Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, VTE, hysterectomy, ICU admission, readmission within 1 week, death | Enrollment to 1 week postpartum | 
| Neonatal Morbidity | Composite neonatal morbidity: Neonatal intensive care (ICN) admission > 48 hours, neonatal blood transfusion, hypoxic ischemic encephalopathy, intraventricular hemorrhage grade III or IV, headcooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death | Enrollment to 1 week postpartum |