Isolated (Idiopathic) Oligohydramnios Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment