Sildenafil Citrate and Recurrent Abortion

Recurrent Abortion Clinical Trial

Official title:

Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475160
• Other study ID #: 18199
• Status: Completed
• Phase: N/A
• First received: March 9, 2018
• Last updated: March 16, 2018
• Start date: December 1, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Recurrent Abortion

Intervention

Drug:
• 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.

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between both groups in live birth	Live birth is defined as an ongoing pregnancy past to the 20th week of gestation	Through study completion, an average of 9 months.
Secondary	Uterine artery PI at cycle day 21-23 preceding pregnancy	The difference between both groups regard PI at cycle day 21-23 preceding pregnancy	At cycle day 21-23 preceding pregnancy
Secondary	Uterine artery RI at cycle day 21-23 preceding pregnancy	The difference between both groups regard RI at cycle day 21-23 preceding pregnancy	At cycle day 21-23 preceding pregnancy
Secondary	Uterine artery PI at the twelfth week of gestation	The difference between both groups regard PI at the twelfth week of gestation	At the twelfth week of gestation.
Secondary	Uterine artery RI at the twelfth week of gestation	The difference between both groups regard RI at the twelfth week of gestation	At the twelfth week of gestation.