Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2015-12-01
2017-12-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sildenafil Citrate
Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Sildenafil Citrate vaginal suppositories
Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
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
Uterine artery Doppler after treatment
Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
Placebo
Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Placebo vaginal suppositories
Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
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
Uterine artery Doppler after treatment
Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
Interventions
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Sildenafil Citrate vaginal suppositories
Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Placebo vaginal suppositories
Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
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
Uterine artery Doppler after treatment
Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
35 Years
FEMALE
No
Sponsors
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Benha University
OTHER
Responsible Party
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Ahmed Walid Anwar Murad
Assistant Professor, Department of Obstetrics and Gynecology
Other Identifiers
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18199
Identifier Type: -
Identifier Source: org_study_id
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