Isolated (Idiopathic) OligohydramniosPhase 2/3NCT02712125
Nitric Oxide Donors for Treatment of Isolated Oligohydramnios
A Phase 2/3 study testing isosorbide mononitrate in people with Isolated (Idiopathic) Oligohydramnios, run by Benha University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Isolated (Idiopathic) Oligohydramnios
- What is being tested?
- isosorbide mononitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- 28-36 weeks gestation,
- Diagnosed isolated oligohydramnios (AFI less than 5 cm).
Who cannot join
- Multiple pregnancy;
- Fetal chromosomal or congenital abnormalities;
- Signs of fetal distress;
- Preterm rupture of membranes;
- Intrauterine infection;
- Receiving treatment for oligohydramnios ;
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- History of maternal heart disease;
- Vasodilator use; sensitivity to NO donors ;
- Pre-existing chronic medical problems.
About this study
Official title: 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.
Read the 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.
- Conditions
- Isolated (Idiopathic) Oligohydramnios
- Being tested
- isosorbide mononitrate, Placebo
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isosorbide mononitrateDrug
Also called Effox 20 mg tablet
20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .
PlaceboDrug
placebo vaginal tablets once daily until delivery
| Study group | Role | What they receive |
|---|---|---|
| isosorbide mononitrate | Active comparator | Received 20 mg isosorbid mononitrate (IMN) (Effox, Mina Pharma Co, Egypt; under license of Schwartz Pharma, Germany) vaginally once daily until delivery Receives: Drug: isosorbide mononitrate |
| Control | Placebo comparator | Received placebo vaginal tablets once daily until delivery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, up to 40 weeks of gestations
Secondary outcomes (4)
Number of participants with isosorbide mononitrate -related adverse events as assessed by CTCAE v4.0.
Measured: Through study completion, up to 40 weeks of gestations
Number of participants with each indication of delivery
Measured: Through study completion, up to 40 weeks of gestations
Number of participants with adverse neonatal outcomes
Measured: At time of delivery.
Number of participants delivered by Cesarean sections or vaginally
Measured: Through study completion, up to 40 weeks of gestations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startAug 2013
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated (Idiopathic) OligohydramniosStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Walid Anwar Murad, Benha University
- Investigators
- Ahmed Walid Anwar Murad, Principal investigator, Department of Obstetrics and Gynecology, Faculty of Medicine, Banha University,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712125
- Sponsor's protocol ID
- Benha-023
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide Donors for Treatment of Isolated Oligohydramnios: A Pilot Study
- ClinicalTrials.gov ID
- NCT02712125
- Acronym / sponsor ID
- Benha-023
- Conditions
- Isolated (Idiopathic) Oligohydramnios
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isosorbide mononitrate | Active comparator | Drug: isosorbide mononitrateReceived 20 mg isosorbid mononitrate (IMN) (Effox, Mina Pharma Co, Egypt; under license of Schwartz Pharma, Germany) vaginally once daily until delivery |
| Control | Placebo comparator | Drug: PlaceboReceived placebo vaginal tablets once daily until delivery |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- 28-36 weeks gestation,
- Diagnosed isolated oligohydramnios (AFI less than 5 cm).
Key exclusion criteria (9 listed)
- Multiple pregnancy;
- Fetal chromosomal or congenital abnormalities;
- Signs of fetal distress;
- Preterm rupture of membranes;
- Intrauterine infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isosorbide mononitrateAlso: Effox 20 mg tablet20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery . | Drug | isosorbide mononitrate |
| Placeboplacebo vaginal tablets once daily until delivery | Drug | Control |
Primary outcome
The change in amniotic fluid index (AFI)in centimeters.
Time frame: Through study completion, up to 40 weeks of gestations
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Walid Anwar Murad principal investigator
Department of Obstetrics and Gynecology, Faculty of Medicine, Banha University,
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing isosorbide mononitrate in people with Isolated (Idiopathic) Oligohydramnios, run by Benha University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in amniotic fluid index (AFI)in centimeters. (time frame: Through study completion, up to 40 weeks of gestations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.