Comparison of the effectiveness of sildenafil plus hydration therapy with the hydration therapy alone on the treatment of oligohydramnios in pregnant women referring to Arash Hospital

The aim of this study was to evaluate the effect of sildenafil on the treatment of oligohydamnios.

This study will be conducted on 52 eligible women with oligohydramnios who have a gestational age greater than 28 weeks. The participants will be randomly divided into two groups of intervention and control.

This is a randomized clinical trial that will be conducted on pregnant women with oligohydramnios at 28 weeks of gestation referred to Arash Hospital. After random allocation, patients will be assigned to control or interventional groups. After being admitted, each patient will receive 2 liters of ringer serum for 24 hours. After 24hr of hydration, AFI will be checked by ultrasound and patients who show at least a 20% improvement in AFI will be discharged from the hospital. After discharge, the intervention group will use 2 liters of water per day plus 25 mg oral sildenafil 3 times a day for 6 weeks. The control group will receive only 2 liters of water per day at the same time. We will perform 2 times a week NST, weekly sonography, and biophysical profile test and will advise mothers to have more rest and count the fetal movements.

Participants should have a singleton pregnancy, gestational age 28 weeks or more, an amniotic fluid index less than 8 centimeters. patients with IUGR, abnormal Doppler or NST, prostaglandin synthase inhibitors treatment, rupture of membranes, active labor, chronic blood pressure, diabetes mellitus and hydration therapy contraindications will be excluded.

Intervention group: sildenafil plus hydration therapy Control group: only hydration therapy

Primary outcome: Amniotic fluid index Secondary outcome: type of delivery; gestational age at delivery; duration of intervention until delivery; fetal weight, APGAR Score, NICU admission

The considered sample size is 52, with 26 people in each group. Block randomization method was designed by the group's epidemiologist using Stata version 13 software. The size of blocks considered is 6. The random allocation list for patients is solely available to the epidemiologist. To hide the random allocation process, 52 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. A 10-digit random code will be written on each packet as the patient's identification number. When the physician announces the eligibility of a patient, the methodologist will provide the envelope.

the statistical analyser will be unaware of the type of intervention performed in the groups.