Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

Recurrent Miscarriage Clinical Trial

Official title:

Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01419392
• Other study ID #: Ahmed-2004
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 17, 2011
• Last updated: April 14, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2012
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether sildenafil citrate is effective in improving uterine artery blood flow and oxidative stress in patients with unexplained recurrent miscarriages

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age 18-35 years

• Three or more recurrent miscarriages before the 24th week of gestation with no apparent cause for their previous losses

• Three or more months have elapsed since the last abortion

• Postmenstrual period

• No other therapy allowed during our treatment course

Exclusion Criteria:

• Concomitant use of organic nitrites, or nitrates

• Severe hepatic, renal, or cardiovascular impairment

• History of stroke or myocardial infarction

• Patients with retinitis pigmentosa.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrent Miscarriage

Intervention

Drug:
• Sildenafil citrate
25 mg orally, 4 times per day for 21 days
• matching placebo
orally, 4 times per day for 21 days

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine arteries blood flow	Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index	21 days	No
Secondary	Nitric oxide serum level as a marked of oxidative stress		21 days	No
Secondary	Total antioxidant capacity serum level as a marker of oxidative stress		21 days	No