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

Phase 4

Completed

• Conditions: Labor, Premature; Preeclampsia
• Interventions: Drug: Monoket Pill; Drug: Placebo

• Registration Number: NCT03171480
• Lead Sponsor: Ohio State University

Brief 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.

Study Timeline

• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-28
• Study First Posted: 2017-05-31
• Study Start: 2017-10-30
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Results First Submitted: 2021-08-05
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-07
• Last Update Submitted: 2021-12-07
• Results First Posted: 2022-01-04
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monoket pill	Monoket Pill	Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris\[1\] and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,
Placebo pill	Placebo	The pharmacy has compounded an identical appearing placebo

Primary Outcome Measures

Name	Time	Method
Cesarean Delivery Rate	7 days	Rate of cesarean section for those enrolled in study

Secondary Outcome Measures

Name	Time	Method
Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid	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

Trial Locations

Locations (1)

The Ohio State Medical Center Labor and Delivery Unit; 🇺🇸 Columbus, Ohio, United States