Nitric Oxide Donors for Treatment of Isolated Oligohydramnios
Primary Purpose
Isolated (Idiopathic) Oligohydramnios
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
isosorbide mononitrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Isolated (Idiopathic) Oligohydramnios
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
isosorbide mononitrate
Control
Arm Description
Received 20 mg isosorbid mononitrate (IMN) (Effox, Mina Pharma Co, Egypt; under license of Schwartz Pharma, Germany) vaginally once daily until delivery
Received placebo vaginal tablets once daily until delivery
Outcomes
Primary Outcome Measures
The change in amniotic fluid index (AFI)in centimeters.
Technique of AFI measurement
Uterus is divided into four imaginary quadrants with linea nigra and umbilicus acting as the vertical and the horizontal axis respectively
The deepest pocket devoid of umbilical cord and fetal parts is measured in the vertical dimension
Measurement of the four pockets is in centimeters
Sum of all the four quadrant measurements is AFI
Normal AFI values range from 5 to 25 cm
Secondary Outcome Measures
Number of participants with isosorbide mononitrate -related adverse events as assessed by CTCAE v4.0.
Number of participants with each indication of delivery
Number of participants with adverse neonatal outcomes
Number of participants delivered by Cesarean sections or vaginally
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02712125
Brief Title
Nitric Oxide Donors for Treatment of Isolated Oligohydramnios
Official Title
Nitric Oxide Donors for Treatment of Isolated Oligohydramnios: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isolated (Idiopathic) Oligohydramnios
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
isosorbide mononitrate
Arm Type
Active Comparator
Arm Description
Received 20 mg isosorbid mononitrate (IMN) (Effox, Mina Pharma Co, Egypt; under license of Schwartz Pharma, Germany) vaginally once daily until delivery
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Received placebo vaginal tablets once daily until delivery
Intervention Type
Drug
Intervention Name(s)
isosorbide mononitrate
Other Intervention Name(s)
Effox 20 mg tablet
Intervention Description
20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo vaginal tablets once daily until delivery
Primary Outcome Measure Information:
Title
The change in amniotic fluid index (AFI)in centimeters.
Description
Technique of AFI measurement
Uterus is divided into four imaginary quadrants with linea nigra and umbilicus acting as the vertical and the horizontal axis respectively
The deepest pocket devoid of umbilical cord and fetal parts is measured in the vertical dimension
Measurement of the four pockets is in centimeters
Sum of all the four quadrant measurements is AFI
Normal AFI values range from 5 to 25 cm
Time Frame
Through study completion, up to 40 weeks of gestations
Secondary Outcome Measure Information:
Title
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
Title
Number of participants with each indication of delivery
Time Frame
Through study completion, up to 40 weeks of gestations
Title
Number of participants with adverse neonatal outcomes
Time Frame
At time of delivery.
Title
Number of participants delivered by Cesarean sections or vaginally
Time Frame
Through study completion, up to 40 weeks of gestations
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Walid Anwar Murad
Organizational Affiliation
Department of Obstetrics and Gynecology, Faculty of Medicine, Banha University,
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Nitric Oxide Donors for Treatment of Isolated Oligohydramnios
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