Pitocin or Oral Misoprostol for PROM IOL

Phase 4

Completed

Conditions: PROM

Interventions: Drug: Misoprostol
Drug: Oxytocin

Registration Number: NCT04028765

Lead Sponsor: University of Pennsylvania

Brief Summary: 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: 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, the American College of Obstetricians and Gynecologists (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 Neonatal Intensive Care Unit (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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 108

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 Group B Strep (GBS) status

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Misoprostol	Misoprostol	-
Oxytocin	Oxytocin	-

Primary Outcome Measures

Name	Time	Method
Time From Induction of Labor (IOL) to Delivery	Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.	Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.

Secondary Outcome Measures

Name	Time	Method
Time From Premature Rupture of Membranes (PROM) to Delivery	Time (hours) from PROM (as reported by patient) to delivery of infant
Neonatal Morbidity	Enrollment to hospital discharge (On average 2-4 days)	Composite neonatal morbidity: NICU admission \> 48 hours, neonatal blood transfusion, hypoxic ischemic encephalopathy, intraventricular hemorrhage grade III or IV, headcooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death
Infection	Enrollment to Delivery	Suspected intraamniotic infection
Time From IOL to Vaginal Delivery	Time from IOL (as defined by receipt of first medication for induction) to vaginal delivery
Cesarean Delivery	Enrollment to Delivery	Cesarean section rate
Time From PROM to Vaginal Delivery	Time (hours) from PROM (as reported by patient) to vaginal delivery
Maternal Morbidity	Enrollment to 4 weeks postpartum	Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, venous thromboembolism (VTE), hysterectomy, Intensive care unit (ICU) admission, readmission within 4 weeks, death