At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 176 enrolled
Drug / intervention
Monoket Pill +1 moredrug
Likely dose
Monoket (isosorbide mononitrate) intra-vaginal application as cervical ripening agentAI-extracted
Key inclusion· 7
- ✓Women age >18 years able to give informed consent
- ✓Clinical diagnosis of preeclampsia as indication for labor induction
- ✓Unfavorable cervix with Bishop's score <6
- ✓Cervical dilation ≤2 cm
Key exclusion· 12
- ✕Contraindication to vaginal delivery
- ✕Fetal demise or major fetal anomaly
- ✕Eclampsia
- ✕HELLP syndrome (hemolysis, elevated liver enzymes, low platelets)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial of Nitric-oxide Donor (NOD) Isosorbide Mononitrate (IMN) Versus Placebo for Induction of Labor in Pregnancies Complicated by Preeclampsia
In Brief
A Phase 4 clinical trial evaluating Monoket Pill and Placebo for Preeclampsia and Labor, Premature. Completed, enrolled 176 participants across 1 site.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreeclampsia, Labor, Premature
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartOct 2017
Primary CompletionJul 2020
TodayJul 2026
First PostedMay 31, 2017
Enrollment StartOct 30, 2017
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago
Interventions
Monoket Pilldrug
Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor
Placebodrug
The pharmacy has compounded an identical appearing placebo