Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses

Not Applicable

Completed

• Conditions: Pregnancy Complication
• Interventions: Drug: sildenafil citrate; Other: placebo

• Registration Number: NCT02362399
• Lead Sponsor: Al Hayat National Hospital

Brief Summary

To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from growth restriction to support its use later as prolonged therapy in those pregnancies at higher risk for such complication.

Detailed Description

Participants were randomized in 1:1 ratio into one of the following drug regime:

Group (I): "sildenafil citrate group" This group consisted of 22 women who received single oral dose of 50 mg sildenafil citrate.

Group (II): "placebo group" This group consisted of 22 women who received single oral dose of placebo. All participants were evaluated by ultrasound once they admitted and again after 2-hours following administration of either of the treatment tablets. One sonographer was allocated to evaluate all mothers included in the study.

Study Timeline

• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-12
• Study Start: 2015-03
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-03
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

Patients were admitted to the study based on the following inclusion criteria:

1. Any age and any party.
2. Body mass index between 25 and 35.
3. Singleton pregnancy.
4. Gestational age of 24 weeks or more. Gestational age was established on the basis of menstrual dates and confirmed by first or second trimester ultrasound for booked patients, however, if a difference of > 7 days or > 10 days during first or second trimester respectively, then ultrasound value was used. For unbooked patients they still have the chance to be included in our study if they can bring a scan that showed gestational age during the same period mentioned before.
5. Idiopathic intrauterine growth restriction.
6. Intrauterine growth restriction due to maternal malnutrition, maternal medical disorder as anemia, pregnancy induced hypertension, or chronic renal disease.
7. Intrauterine growth restriction due to substance abuse (including smoking).
8. With or without past history of intrauterine growth restriction .

Exclusion Criteria

1. Intrauterine growth restriction due to fetal causes as congenital abnormalities, fetal infection, or multiple gestation.
2. Any drug therapy that can affect fetal growth or fetal blood supply.
3. Maternal diseases that contraindicates the use of sildenafil citrate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sildenafil citrate	sildenafil citrate	50 mg single oral dose
placebo	placebo	single tablet of placebo

Primary Outcome Measures

Name	Time	Method
improvement of the Doppler indices following treatment	9 months

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shebin Elkom, Egypt