An interventional study of Sildenafil Citrate vaginal suppositories and Placebo vaginal suppositories in Recurrent Abortion, sponsored by Benha University. Completed. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
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.
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).
102 studies on the registry are indexed under Abortion, Habitual; 21 are open to participants now.
This study's enrollment of 130 is close to the median of 126 across 55 interventional studies indexed under Abortion, Habitual.
Browse Abortion, Habitual studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Drug: Sildenafil Citrate vaginal suppositories · Procedure: Uterine artery Doppler before treatment · Procedure: Uterine artery Doppler after treatment
Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Drug: Placebo vaginal suppositories · Procedure: Uterine artery Doppler before treatment · Procedure: Uterine artery Doppler after treatment
Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Also known as: Sildenafil Citrate
Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Also known as: Placebo
Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy
Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
The difference between both groups in live birth
Live birth is defined as an ongoing pregnancy past to the 20th week of gestation
Time frame: Through study completion, an average of 9 months.
Uterine artery PI at cycle day 21-23 preceding pregnancy
The difference between both groups regard PI at cycle day 21-23 preceding pregnancy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the twelfth week of gestation.
No study locations are listed for this record.
Ran from Dec 2015 to primary completion in Dec 2017, 24 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sildenafil