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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
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Isolated (Idiopathic) Oligohydramnios

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    March 2, 2016
    Last Updated
    March 14, 2016
    Sponsor
    Benha University
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    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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