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Pitocin or Oral Misoprostol for PROM IOL (POM PROM)

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ClinicalTrials.gov Identifier: NCT04028765
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa Levine, 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.

Condition or disease Intervention/treatment Phase
PROM Drug: Misoprostol Drug: Oxytocin Phase 4

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, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: POM PROM: Pitocin or Oral Misoprostol for PROM IOL in Nulliparous Women With Unfavorable Cervical Exams
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oral Misoprostol
Oral misoprostol 50 mcg q4H for up to 6 doses or until cervical ripening is no longer indicated
Drug: Misoprostol
As above

Active Comparator: Oxytocin
IV Oxytocin 2mU/min, increased by 2mU/min q15 minutes per hospital protocol
Drug: Oxytocin
As above




Primary Outcome Measures :
  1. Time from IOL to delivery [ Time Frame: Enrollment to Delivery ]
    Time (hours) from start of IOL to delivery


Secondary Outcome Measures :
  1. Infection [ Time Frame: Enrollment to Delivery ]
    Suspected intraamniotic infection

  2. Time from PROM to delivery [ Time Frame: Enrollment to Delivery ]
    Time (hours) from PROM to delivery

  3. Time from IOL to vaginal delivery [ Time Frame: Enrollment to Delivery ]
    Time (hours) from PROM to delivery

  4. Time from PROM to vaginal delivery [ Time Frame: Enrollment to Delivery ]
    Time (hours) from PROM to vaginal delivery

  5. Cesarean delivery [ Time Frame: Enrollment to Delivery ]
    Cesarean section rate

  6. Maternal morbidity [ Time Frame: Enrollment to 1 week postpartum ]
    Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, VTE, hysterectomy, ICU admission, readmission within 1 week, death

  7. Neonatal Morbidity [ Time Frame: Enrollment to 1 week postpartum ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028765


Contacts
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Contact: Whitney R Bender, MD 4342948416 whitney.bender@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Whitney R Bender, MD    434-294-8416    whitney.bender@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania

Publications:

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Responsible Party: Lisa Levine, Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04028765     History of Changes
Other Study ID Numbers: 833536
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Pregnancy Complications
Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents