Nitric Oxide Donors for Treatment of Isolated Oligohydramnios

NCT02712125 | Completed Phase 2 DMC

• 1 other identifier: Benha-023
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Isolated (Idiopathic) Oligohydramnios

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Through study completion, up to 40 weeks of gestations

• Number of participants with each indication of delivery

  Through study completion, up to 40 weeks of gestations

• Number of participants with adverse neonatal outcomes

  At time of delivery.

• Number of participants delivered by Cesarean sections or vaginally

  Through study completion, up to 40 weeks of gestations

Study Arms (2)

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

Drug: isosorbide mononitrate

Control

PLACEBO COMPARATOR

Received placebo vaginal tablets once daily until delivery

Drug: Placebo

Interventions

isosorbide mononitrate DRUG

20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .

Also known as: Effox 20 mg tablet

isosorbide mononitrate

Placebo DRUG

placebo vaginal tablets once daily until delivery

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• weeks gestation,
• Diagnosed isolated oligohydramnios (AFI less than 5 cm).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

MeSH Terms

Conditions

Oligohydramnios

Interventions

isosorbide-5-mononitrate; Tablets

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ahmed Walid Anwar Murad

  Department of Obstetrics and Gynecology, Faculty of Medicine, Banha University,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 18, 2016
• Study Start: August 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03