Nitric Oxide Donors for Treatment of Isolated Oligohydramnios
Condition: Isolated (Idiopathic) Oligohydramnios
MeSH terms: Oligohydramnios
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): isosorbide mononitrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .; placebo vaginal tablets once daily until delivery
Other intervention name(s): Effox 20 mg tablet
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment