- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028765
Pitocin or Oral Misoprostol for PROM IOL (POM PROM)
POM PROM: Pitocin or Oral Misoprostol for PROM IOL in Nulliparous Women With Unfavorable Cervical Exams
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Whitney R Bender, MD
- Phone Number: 4342948416
- Email: whitney.bender@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oxytocin
|
IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol
|
Active Comparator: Oral Misoprostol
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Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time from IOL to delivery
Time Frame: Enrollment to Delivery
|
Time (hours) from start of IOL to delivery
|
Enrollment to Delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infection
Time Frame: Enrollment to Delivery
|
Suspected intraamniotic infection
|
Enrollment to Delivery
|
Time from PROM to delivery
Time Frame: Enrollment to Delivery
|
Time (hours) from PROM to delivery
|
Enrollment to Delivery
|
Time from IOL to vaginal delivery
Time Frame: Enrollment to Delivery
|
Time (hours) from PROM to delivery
|
Enrollment to Delivery
|
Time from PROM to vaginal delivery
Time Frame: Enrollment to Delivery
|
Time (hours) from PROM to vaginal delivery
|
Enrollment to Delivery
|
Cesarean delivery
Time Frame: Enrollment to Delivery
|
Cesarean section rate
|
Enrollment to Delivery
|
Maternal morbidity
Time Frame: Enrollment to 1 week postpartum
|
Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, venous thromboembolism (VTE), hysterectomy, Intensive care unit (ICU) admission, readmission within 1 week, death
|
Enrollment to 1 week postpartum
|
Neonatal Morbidity
Time Frame: Enrollment to 1 week postpartum
|
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
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Enrollment to 1 week postpartum
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 188: Prelabor Rupture of Membranes. Obstet Gynecol. 2018 Jan;131(1):e1-e14. doi: 10.1097/AOG.0000000000002455.
- Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
- Al-Hussaini TK, Abdel-Aal SA, Youssef MA. Oral misoprostol vs. intravenous oxytocin for labor induction in women with prelabor rupture of membranes at term. Int J Gynaecol Obstet. 2003 Jul;82(1):73-5. doi: 10.1016/s0020-7292(03)00136-x. No abstract available.
- Crane JM, Delaney T, Hutchens D. Oral misoprostol for premature rupture of membranes at term. Am J Obstet Gynecol. 2003 Sep;189(3):720-4. doi: 10.1067/s0002-9378(03)00768-3.
- Butt KD, Bennett KA, Crane JM, Hutchens D, Young DC. Randomized comparison of oral misoprostol and oxytocin for labor induction in term prelabor membrane rupture. Obstet Gynecol. 1999 Dec;94(6):994-9. doi: 10.1016/s0029-7844(99)00423-8.
- Ngai SW, Chan YM, Lam SW, Lao TT. Labour characteristics and uterine activity: misoprostol compared with oxytocin in women at term with prelabour rupture of the membranes. BJOG. 2000 Feb;107(2):222-7. doi: 10.1111/j.1471-0528.2000.tb11693.x.
- Mozurkewich E, Horrocks J, Daley S, Von Oeyen P, Halvorson M, Johnson M, Zaretsky M, Tehranifar M, Bayer-Zwirello L, Robichaux A 3rd, Droste S, Turner G; MisoPROM study. The MisoPROM study: a multicenter randomized comparison of oral misoprostol and oxytocin for premature rupture of membranes at term. Am J Obstet Gynecol. 2003 Oct;189(4):1026-30. doi: 10.1067/s0002-9378(03)00845-7.
- Mbaluka CM, Kamau K, Karanja JG, Mugo N. EFFECTIVENESS AND SAFETY OF 2-HOURLY 20 MCG ORAL MISOPROSTOL SOLUTION COMPARED TO STANDARD INTRAVENOUS OXYTOCIN IN LABOUR INDUCTION DUE TO PRE-LABOUR RUPTURE OF MEMBRANES AT TERM: A RANDOMISED CLINICAL TRIAL AT KENYATTA NATIONAL HOSPITAL. East Afr Med J. 2014 Sep;91(9):303-10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Obstetric Labor Complications
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Fetal Membranes, Premature Rupture
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Reproductive Control Agents
- Anti-Ulcer Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Oxytocin
- Misoprostol
Other Study ID Numbers
- 833536
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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