A Phase 2/3 interventional study of isosorbide mononitrate and Placebo in Isolated (Idiopathic) Oligohydramnios, sponsored by Benha University. Completed. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-03-18.
Sponsored by Benha University · Phase 2/3, Interventional, and Treatment
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.
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.
25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.
This study's enrollment of 100 is close to the median of 91 across 16 interventional studies indexed under Oligohydramnios.
Browse Oligohydramnios studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
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
Received placebo vaginal tablets once daily until delivery
Drug: Placebo
20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .
Also known as: Effox 20 mg tablet
placebo vaginal tablets once daily until delivery
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
Time frame: Through study completion, up to 40 weeks of gestations
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
No study locations are listed for this record.
The record gives a start of Aug 2013, a primary completion of Jun 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Isosorbide mononitrate