Sildenafil Citrate and Recurrent Abortion

Not Applicable

Completed

• Conditions: Recurrent Abortion
• Interventions: Drug: Sildenafil Citrate vaginal suppositories; Drug: Placebo vaginal suppositories; Procedure: Uterine artery Doppler before treatment; Procedure: Uterine artery Doppler after treatment

• Registration Number: NCT03475160
• Lead Sponsor: Benha University

Brief 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).

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-16
• Last Update Submitted: 2018-03-16
• Study First Posted: 2018-03-23
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Unexplained recurrent spontaneous abortion.

Exclusion Criteria

• Abnormal uterine cavity.
• Luteal phase insufficiency.
• Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus.
• Antiphospholipid syndrome.
• Inherited or acquired thrombophilia.
• Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil Citrate	Sildenafil Citrate vaginal suppositories	Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Sildenafil Citrate	Uterine artery Doppler before treatment	Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Sildenafil Citrate	Uterine artery Doppler after treatment	Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Placebo	Placebo vaginal suppositories	Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Placebo	Uterine artery Doppler before treatment	Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Placebo	Uterine artery Doppler after treatment	Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Primary Outcome Measures

Name	Time	Method
The difference between both groups in live birth	Through study completion, an average of 9 months.	Live birth is defined as an ongoing pregnancy past to the 20th week of gestation

Secondary Outcome Measures

Name	Time	Method
Uterine artery PI at cycle day 21-23 preceding pregnancy	At cycle day 21-23 preceding pregnancy	The difference between both groups regard PI at cycle day 21-23 preceding pregnancy
Uterine artery RI at cycle day 21-23 preceding pregnancy	At cycle day 21-23 preceding pregnancy	The difference between both groups regard RI at cycle day 21-23 preceding pregnancy
Uterine artery PI at the twelfth week of gestation	At the twelfth week of gestation.	The difference between both groups regard PI at the twelfth week of gestation
Uterine artery RI at the twelfth week of gestation	At the twelfth week of gestation.	The difference between both groups regard RI at the twelfth week of gestation