Clinical Trial: Nitric Oxide Donors for Treatment of Isolated Oligohydramnios

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nitric Oxide Donors for Treatment of Isolated Oligohydramnios: A Pilot Study

Brief 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.

Detailed Summary:

This prospective randomized interventional study was done in Obstetrics and Gynecology Department , Benha University Hospital, Alkalubia, Egypt from August 2013 to August 2015.

The study protocol was approved by the Local Ethics Committee and written informed consents were taken from patients entering the study. The study included 100 women aged 18-35 years with singleton pregnancy about 28-36 weeks gestation, with diagnosed isolated oligohydramnios (AFI less than 5 cm).

Initially, all the participants were subjected to through routine antenatal history taking and examination and by routine ultrasound scan using (Voluson, 730 Pro V, GE Medical System), AFI was assessed. All participants were instructed to take regularly the daily water requirement, especially in the two days before starting the study and throughout the study. Participants were randomly scheduled into two equal groups by computer-generated blocks into a control group received placebo vaginal tablets and a study group received 20 mg isosorbide mononitrate (IMN) vaginally once daily until delivery (Effox, Mina Pharma Co, Egypt; under license of Schwartz Pharma, Germany). Treatment allocation was concealed by using sequentially numbered opaque sealed envelopes, opened sequentially by a third person (study nurse). Amniotic fluid index was rechecked after two days and followed up weekly till delivery by one person to avoid interobserver variability. Drug treatment continues until the volume of the fluid reach the normal value or until delivery. Antenatal vitamins were continued.

Primary outcome measure was the change in AFI.

Secondary outcome measures were the side effect of isosorbide mononitrate if any, indications and mode of delivery, and neonatal outcomes as
Sponsor: Benha University

Current Primary Outcome: The change in amniotic fluid index (AFI)in centimeters. [ Time Frame: Through study completion, up to 40 weeks of gestations ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of participants with isosorbide mononitrate -related adverse events as assessed by CTCAE v4.0. [ Time Frame: Through study completion, up to 40 weeks of gestations ]
• Number of participants with each indication of delivery [ Time Frame: Through study completion, up to 40 weeks of gestations ]
• Number of participants with adverse neonatal outcomes [ Time Frame: At time of delivery. ]
• Number of participants delivered by Cesarean sections or vaginally [ Time Frame: Through study completion, up to 40 weeks of gestations ]

Original Secondary Outcome: Same as current

Information By: Benha University

Dates:
Date Received: March 2, 2016
Date Started: August 2013
Date Completion:
Last Updated: March 14, 2016
Last Verified: March 2016