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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy
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.
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Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation