Nitric Oxide Donors for Treatment of Isolated Oligohydramnios

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benha University
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Nitric Oxide; Nitric Oxide Donors

Criteria

Inclusion Criteria:

• Singleton pregnancy

• 28-36 weeks gestation,

• Diagnosed isolated oligohydramnios (AFI less than 5 cm).

Exclusion Criteria:

• Multiple pregnancy;

• Fetal chromosomal or congenital abnormalities;

• Signs of fetal distress;

• Preterm rupture of membranes;

• Intrauterine infection;

• Receiving treatment for oligohydramnios ;

• History of maternal heart disease;

• Vasodilator use; sensitivity to NO donors ;

• Pre-existing chronic medical problems.