Sildenafil Citrate and Recurrent Abortion

NCT ID: NCT03475160

Last Updated: 2018-03-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2017-12-01

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).

Conditions

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Recurrent Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type ACTIVE_COMPARATOR

Sildenafil Citrate vaginal suppositories

Intervention Type DRUG

Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Uterine artery Doppler before treatment

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Group Type PLACEBO_COMPARATOR

Placebo vaginal suppositories

Intervention Type DRUG

Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Uterine artery Doppler before treatment

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Placebo vaginal suppositories

Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Intervention Type DRUG

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

Intervention Type PROCEDURE

Uterine artery Doppler after treatment

Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation

Intervention Type PROCEDURE

Other Intervention Names

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Sildenafil Citrate Placebo

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Walid Anwar Murad

Assistant Professor, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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18199

Identifier Type: -

Identifier Source: org_study_id

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