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PROMMO Trial: Oral Misoprostol vs IV Oxytocin

NCT04478942 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-08-28

No results posted yet for this study

Summary

This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.

Conditions

  • Premature Rupture of Membrane
  • Induction of Labor Affected Fetus / Newborn

Interventions

DRUG

Misoprostol Oral Product

Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.

DRUG

Intravenous Oxytocin

Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Jacquelyn Adams, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2025-01-14
Completion
2025-01-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04478942 on ClinicalTrials.gov