- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02712125
Nitric Oxide Donors for Treatment of Isolated Oligohydramnios
Nitric Oxide Donors for Treatment of Isolated Oligohydramnios: A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 regard birth weight, still birth or neonatal death, Apgar score and the need for neonatal admission.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: isosorbide mononitrate
Received 20 mg isosorbid mononitrate (IMN) (Effox, Mina Pharma Co, Egypt; under license of Schwartz Pharma, Germany) vaginally once daily until delivery
|
20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .
Other Names:
|
Placebo Comparator: Control
Received placebo vaginal tablets once daily until delivery
|
placebo vaginal tablets once daily until delivery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in amniotic fluid index (AFI)in centimeters.
Time Frame: Through study completion, up to 40 weeks of gestations
|
Technique of AFI measurement
|
Through study completion, up to 40 weeks of gestations
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Through study completion, up to 40 weeks of gestations
|
Number of participants with adverse neonatal outcomes
Time Frame: At time of delivery.
|
At time of delivery.
|
Number of participants delivered by Cesarean sections or vaginally
Time Frame: Through study completion, up to 40 weeks of gestations
|
Through study completion, up to 40 weeks of gestations
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Walid Anwar Murad, Department of Obstetrics and Gynecology, Faculty of Medicine, Banha University,
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Benha-023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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