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Completed

NCT Number: NCT03171480

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

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)

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Ohio State Medical Center Labor and Delivery Unit

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women older than 18 years at the time of induction of labor with the ability to give informed consent
  • Induction of labor for clinical diagnosis of preeclampsia
  • Unfavorable cervix (Bishop's score of less than 6)
  • Cervical dilation 2cm or less
  • Singleton
  • Gestational age ≥ 24 weeks
  • English speaking

Exclusion criteria

  • • Contraindication to vaginal delivery
  • Contraindication to misoprostol
  • Fetal Demise
  • Major fetal anomaly
  • Non-english speaking women
  • HIV
  • Medical conditions requiring assisted second stage
  • Category III tracing
  • Eclampsia
  • Hemolysis Elevated Liver enzymes Low Platelets syndrome
  • DIC or active hemorrhage before randomization
  • Hypersensitivity to isosorbide mononitrate
  • Isosorbide mononitrate should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g following a head trauma and including cerebral hemorrhage.
  • Isosorbide mononitrate should not be used in patients with severe anemia, severe hypotension, closed angle glaucoma or severe hypovolaemia.
  • Isosorbide mononitrate tablets contain lactose and therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Treatment and study plan

Monoket Pill

Drug

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

Other names: Isosorbide mononitrate

Placebo

Drug

The pharmacy has compounded an identical appearing placebo

Primary outcomes

  1. Cesarean Delivery Rate

    Time frame: 7 days

    Rate of cesarean section for those enrolled in study

Secondary outcomes

  1. Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid

    Time frame: during the induction of labor till delivery for all outcomes

    placenta abruption at time of delivery, administration of IV antihypertensive medication for BP >160/110, maternal hypotensive defined as <90/50, Uterine hyperstimulation defined as >3 contractions in 10 minutes and meconium stained amniotic fluid anytime during labor induction/augmentation

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Acronym: NOPE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 31, 2017
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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