Pitocin or Oral Misoprostol for PROM IOL

PROM Clinical Trial

— POM PROM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028765
• Other study ID #: 833536
• Status: Completed
• Phase: Phase 4
• Start date: August 12, 2019
• Est. completion date: January 8, 2023

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 8, 2023
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• PROM

Intervention

Drug:
• Misoprostol
Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
• Oxytocin
IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Infection	Suspected intraamniotic infection	Enrollment to Delivery
Secondary	Time From Premature Rupture of Membranes (PROM) to Delivery		Time (hours) from PROM (as reported by patient) to delivery of infant
Secondary	Time From IOL to Vaginal Delivery		Time from IOL (as defined by receipt of first medication for induction) to vaginal delivery
Secondary	Time From PROM to Vaginal Delivery		Time (hours) from PROM (as reported by patient) to vaginal delivery
Secondary	Cesarean Delivery	Cesarean section rate	Enrollment to Delivery
Secondary	Maternal Morbidity	Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, venous thromboembolism (VTE), hysterectomy, Intensive care unit (ICU) admission, readmission within 4 weeks, death	Enrollment to 4 weeks postpartum
Secondary	Neonatal Morbidity	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	Enrollment to hospital discharge (On average 2-4 days)