drugset / Trial / NCT02712125

Nitric Oxide Donors for Treatment of Isolated Oligohydramnios

NCT02712125

Phase 2/3 Completed 100 enrolled Benha University
RandomizedParallel-groupDouble-blindTreatment

Summary

Objective: To assess the influence of maternal isosorbide mononitrate (IMN) vaginal supplementation in improving liquor volume in women with isolated oligohydramnios. Study Design: Prospective randomized interventional study. Materials and Methods: 100 women with singleton pregnancy about 28-36 weeks, with isolated oligohydramnios \[amniotic fluid index (AFI) \< 5\] were enrolled in the study. Before the proposed intervention, the antenatal risk factors were studied. Patients received 20 mg isosorbide mononitrate (IMN) vaginally. Patient were followed after 24 hours then weekly. The treatment was continued till the liquor improved significantly or until delivery. Outcome measures; mean increase in liquor, intervention delivery interval, and neonatal outcome were studied.

Timeline

Start
2013-08
Primary completion
2015-06
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isosorbide Mononitrate Other / unclassified 20 mg Other

Indications