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Nitric Oxide Donors for Treatment of Isolated Oligohydramnios

NCT02712125 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-03-18

No results posted yet for this study

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.

Conditions

  • Isolated (Idiopathic) Oligohydramnios

Interventions

DRUG

isosorbide mononitrate

20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .

DRUG

Placebo

placebo vaginal tablets once daily until delivery

Sponsors & Collaborators

  • Benha University

    lead OTHER

Principal Investigators

  • Ahmed Walid Anwar Murad · Department of Obstetrics and Gynecology, Faculty of Medicine, Banha University,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-06-30
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712125 on ClinicalTrials.gov