Sildenafil Citrate and Recurrent Abortion

Study Overview
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Brief Summary
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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
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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).

Official Title
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Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion

Conditions
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Recurrent Abortion

Intervention / Treatment
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* Drug: Sildenafil Citrate vaginal suppositories
* Drug: Placebo vaginal suppositories
* Procedure: Uterine artery Doppler before treatment
* Procedure: Uterine artery Doppler after treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sildenafil Citrate<br>Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. | Drug: Sildenafil Citrate vaginal suppositories<br>* Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.<br>* Other names: Sildenafil Citrate;Procedure: Uterine artery Doppler before treatment<br>* Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy<br>Procedure: Uterine artery Doppler after treatment<br>* Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation<br>|
| Placebo Comparator: Placebo<br>Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. | Drug: Placebo vaginal suppositories<br>* Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.<br>* Other names: Placebo;Procedure: Uterine artery Doppler before treatment<br>* Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy<br>Procedure: Uterine artery Doppler after treatment<br>* Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine artery PI at cycle day 21-23 preceding pregnancy | The difference between both groups regard PI at cycle day 21-23 preceding pregnancy | At cycle day 21-23 preceding pregnancy | 
| Uterine artery RI at cycle day 21-23 preceding pregnancy | The difference between both groups regard RI at cycle day 21-23 preceding pregnancy | At cycle day 21-23 preceding pregnancy | 
| Uterine artery PI at the twelfth week of gestation | The difference between both groups regard PI at the twelfth week of gestation | At the twelfth week of gestation. | 
| Uterine artery RI at the twelfth week of gestation | The difference between both groups regard RI at the twelfth week of gestation | At the twelfth week of gestation. |