Phase 4
N=176
Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia
Preeclampsia · Labor, Premature
Bottom Line
View on ClinicalTrials.gov: NCT03171480 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Cesarean Delivery Rate — 29; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Monoket Pill (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cesarean Delivery Rate |
29; 22 | — |
| SECONDARY Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid |
0; 0; 29; 32; 9; 8 | — |
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)
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03171480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.