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Completed

NCT Number: NCT04028765

Pitocin or Oral Misoprostol for PROM IOL

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated

Oxytocin

Drug

IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol

Primary outcomes

  1. Time From Induction of Labor (IOL) to Delivery

    Time frame: 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 outcomes

  1. Infection

    Time frame: Enrollment to Delivery

    Suspected intraamniotic infection

  2. Time From Premature Rupture of Membranes (PROM) to Delivery

    Time frame: Time (hours) from PROM (as reported by patient) to delivery of infant

  3. Time From IOL to Vaginal Delivery

    Time frame: Time from IOL (as defined by receipt of first medication for induction) to vaginal delivery

  4. Time From PROM to Vaginal Delivery

    Time frame: Time (hours) from PROM (as reported by patient) to vaginal delivery

  5. Cesarean Delivery

    Time frame: Enrollment to Delivery

    Cesarean section rate

  6. Maternal Morbidity

    Time frame: 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

  7. Neonatal Morbidity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: POM PROM

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 23, 2019
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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