Randomized Controlled Trial of Nitric-oxide Donor (NOD) Isosorbide Mononitrate (IMN) Versus Placebo for Induction of Labor in Pregnancies Complicated by Preeclampsia
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 42
Healthy Volunteers: f
View:
• 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
Locations
United States
Ohio
The Ohio State Medical Center Labor and Delivery Unit
Columbus
Time Frame
Start Date: 2017-10-30
Completion Date: 2020-07-01
Participants
Target number of participants: 176
Treatments
Experimental: 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,
Placebo_comparator: Placebo pill
The pharmacy has compounded an identical appearing placebo
Authors
Related Therapeutic Areas
Sponsors
Leads: Ohio State University