Sildenafil Citrate and Recurrent Abortion

Benha University

Status: Completed

Conditions: Recurrent Abortion

Treatments: Drug: Placebo vaginal suppositories; Procedure: Uterine artery Doppler after treatment; Drug: Sildenafil Citrate vaginal suppositories; Procedure: Uterine artery Doppler before treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03475160

18199

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 130 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

Sildenafil Citrate

Active Comparator group

Description:

Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Treatment:

Procedure: Uterine artery Doppler after treatment

Procedure: Uterine artery Doppler before treatment

Drug: Sildenafil Citrate vaginal suppositories

Placebo

Placebo Comparator group

Description:

Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Treatment:

Procedure: Uterine artery Doppler after treatment

Procedure: Uterine artery Doppler before treatment

Drug: Placebo vaginal suppositories