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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2020-07-01

Brief Summary

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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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Detailed Description

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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

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Preeclampsia Labor, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

A double blinded, placebo controlled, randomized clinical trial of patients undergoing induction of labor for preeclampsia. Study drug or identical appearing placebo will be delivered to labor floor by pharmacist, after randomization.

Study Groups

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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,

Group Type EXPERIMENTAL

Monoket Pill

Intervention Type DRUG

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

Placebo pill

The pharmacy has compounded an identical appearing placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The pharmacy has compounded an identical appearing placebo

Interventions

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Monoket Pill

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

Intervention Type DRUG

Placebo

The pharmacy has compounded an identical appearing placebo

Intervention Type DRUG

Other Intervention Names

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Isosorbide mononitrate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No