NCT03475160

Sildenafil Citrate and Recurrent Abortion

Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation. The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard pulsatility index (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications.

Detailed description

Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation. The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (\|IUGR).

Conditions

• Recurrent Abortion

Interventions

Type	Name	Description
DRUG	Sildenafil Citrate vaginal suppositories	Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
DRUG	Placebo vaginal suppositories	Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
PROCEDURE	Uterine artery Doppler before treatment	Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy
PROCEDURE	Uterine artery Doppler after treatment	Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2018-03-23
• Last updated: 2018-03-23