Sildenafil Citrate and Recurrent Abortion

Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Abortion
• Intervention / Treatment: Drug: Sildenafil Citrate vaginal suppositories; Procedure: Uterine artery Doppler before treatment; Procedure: Uterine artery Doppler after treatment; Drug: Placebo vaginal suppositories

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sildenafil Citrate; Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.	Drug: Sildenafil Citrate vaginal suppositories; Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.; Other Names: Sildenafil Citrate; 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; Procedure: Uterine artery Doppler after treatment; Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
Placebo Comparator: Placebo; Placebo vaginal suppositories: every 6 hours. 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; Procedure: Uterine artery Doppler after treatment; Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation; Drug: Placebo vaginal suppositories; Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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.

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Abortion, Spontaneous; Recurrence; Abortion, Habitual; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Anticoagulants; Phosphodiesterase Inhibitors; Chelating Agents; Sequestering Agents; Phosphodiesterase 5 Inhibitors; Calcium Chelating Agents; Sildenafil Citrate; Citric Acid; Sodium Citrate
• Other Study ID Numbers: 18199

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No