NCT03171480

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

Randomized Controlled Trial of Nitric-oxide Donor (NOD) Isosorbide Mononitrate (IMN) Versus Placebo for Induction of Labor in Pregnancies Complicated by Preeclampsia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The investigators are proposing a double blinded, placebo controlled, randomized clinical trial of patients undergoing induction of labor for preeclampsia. Once the decision to induce will be taken, the participants will be randomized to receive either intravaginal IMN (40mg) or identical appearing placebo placed every 4hrs in the posterior vaginal fornix X 3 doses. IMN or placebo will be discontinued when active labor occurs or when the physician decides to proceed with augmentation with oxytocin or AROM. Participants will be induced using the investigators routine induction agents, Misoprostol (25 mcg every 4 hrs for maximum of 6 doses) and an intra-cervical foley bulb will be inserted with 2nd dose of IMN or placebo. Regarding management of labor, physician decides when to proceed with augmentation with oxytocin or AROM.

Conditions

• Preeclampsia
• Labor, Premature

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-10-30
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2017-05-31
• Last updated: 2022-01-04
• Results posted: 2022-01-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study