POM PROM: Pitocin or Oral Misoprostol for PROM IOL
Study Details
Study Description
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 |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Time from IOL to delivery [Enrollment to Delivery]
Time (hours) from start of IOL to delivery
Secondary Outcome Measures
- Infection [Enrollment to Delivery]
Suspected intraamniotic infection
- Time from PROM to delivery [Enrollment to Delivery]
Time (hours) from PROM to delivery
- Time from IOL to vaginal delivery [Enrollment to Delivery]
Time (hours) from PROM to delivery
- Time from PROM to vaginal delivery [Enrollment to Delivery]
Time (hours) from PROM to vaginal delivery
- Cesarean delivery [Enrollment to Delivery]
Cesarean section rate
- Maternal morbidity [Enrollment to 1 week postpartum]
Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, VTE, hysterectomy, ICU admission, readmission within 1 week, death
- Neonatal Morbidity [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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
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