Sildenafil Citrate Therapy for Oligohydramnios

• Register: ClinicalTrials.gov
• Last refreshed on: 15 February 2016
• Main ID: NCT02372487
• Date of registration: 10/02/2015
• Prospective Registration: Yes
• Primary sponsor: Al Hayat National Hospital
• Public title: Sildenafil Citrate Therapy for Oligohydramnios
• Scientific title: Sildenafil Citrate Therapy for Oligohydramnios
• Date of first enrolment: March 2015
• Target sample size: 184
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02372487
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Egypt, Saudi Arabia

Key inclusion & exclusion criteria

Inclusion Criteria:

Pregnant women will be included if they are of:

1. any age, any parity

2. carrying a singleton pregnancy

3. gestational age (GA) 30 weeks or more (based on the last menstrual period and
confirmed by the results of ultrasound or determined through early pregnancy
sonography)

4. Amniotic fluid index = 5

5. no pregnancy complications such as preeclampsia, gestational hypertension, or
diabetes

6. no prior history of kidney, lung, and heart disease (the use of bolus-fluid therapy
is contraindicated in these patients)

7. intact fetal membranes.

Exclusion Criteria:

1. Mothers treated with prostaglandin synthetase inhibitors

2. well established labor

3. evidence of fetal distress (non-reactive non stress test)

4. fetal complications (intrauterine growth retardation or obvious fetal anomalies)



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy Complication

Intervention(s)

Dietary Supplement: fluid therapy

Drug: sildenafil citrate

Primary Outcome(s)

the values of amniotic fluid index before and after therapy in each group and between both groups [Time Frame: 9 months]

Secondary Outcome(s)

the need for transfer to the neonatal intensive care unit [Time Frame: 9 months]

fetal birth weight [Time Frame: 9 months]

mode of delivery [Time Frame: 9 months]

Apgar scores [Time Frame: 9 months]

gestational age at birth [Time Frame: 9 months]

Secondary ID(s)

ob/gyn 3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Menoufia University