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



Status:Recruiting
Conditions:Women's Studies, Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 42
Updated:4/17/2018
Start Date:October 30, 2017
End Date:August 2020
Contact:Kara Rood, MD
Email:kara.rood@osumc.edu
Phone:4403210264

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

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.

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.
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Kara M Rood, MD
Phone: 440-321-0264
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mi
from
Columbus, OH
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