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Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia

NCT03171480 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2022-01-04

Study results available
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Summary

A randomized controlled trial (RCT) of nitric-oxide donor (NOD) isosorbide mononitrate (IMN) versus placebo as an adjuvant to misoprostol/ intra-cervical Foley bulb for induction of labor to decrease rate of cesarean deliveries in pregnancies complicated by preeclampsia (≥24/0 weeks' gestation)

Conditions

Interventions

DRUG

Monoket Pill

Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor

DRUG

Placebo

The pharmacy has compounded an identical appearing placebo

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Kara Rood, MD · The Ohio State Wexner Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2020-07-01
Completion
2020-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03171480 on ClinicalTrials.gov