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

• Status: Completed
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

Criteria

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.