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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
176
Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor
The pharmacy has compounded an identical appearing placebo
The Ohio State Medical Center Labor and Delivery Unit
Columbus, Ohio, United States
Cesarean Delivery Rate
Rate of cesarean section for those enrolled in study
Time frame: 7 days
Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid
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
Time frame: during the induction of labor till delivery for all outcomes
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