Pitocin or Oral Misoprostol for PROM IOL

NCT04028765 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 833536
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

PROM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Infection

  Enrollment to Delivery

• Time From Premature Rupture of Membranes (PROM) to Delivery

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

• Time From IOL to Vaginal Delivery

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

• Time From PROM to Vaginal Delivery

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

• Cesarean Delivery

  Enrollment to Delivery

Study Arms (2)

Oral Misoprostol

ACTIVE COMPARATOR

Drug: Misoprostol

Oxytocin

ACTIVE COMPARATOR

Drug: Oxytocin

Interventions

Misoprostol DRUG

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

Oral Misoprostol

Oxytocin DRUG

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

Oxytocin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior cesarean section
• Other contraindication to vaginal delivery
• Intrauterine Fetal Demise
• Major Congenital Anomaly
• Intraamniotic infection diagnosed at time of admission
• weeks - 36 weeks and 6 days with unknown Group B Strep (GBS) status

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

• 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.

  PMID: 29266075 BACKGROUND

• 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.

  PMID: 8598837 BACKGROUND

• 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.

  PMID: 12834947 BACKGROUND

• 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.

  PMID: 14526301 BACKGROUND

• 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.

  PMID: 10576189 BACKGROUND

• 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.

  PMID: 10688506 BACKGROUND

• 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.

  PMID: 14586349 BACKGROUND

• 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.

  PMID: 26866082 BACKGROUND

MeSH Terms

Interventions

Misoprostol; Oxytocin

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Whitney Bender
• Organization: Thomas Jefferson University Health System

whitney.bender@jefferson.edu

4342948416

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: August 12, 2019
• Primary Completion: December 8, 2022
• Study Completion: January 8, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)