Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

Ain Shams University

Status and phase: Unknown; Phase 4

Conditions: Recurrent Miscarriage

Treatments: Drug: matching placebo; Drug: Sildenafil citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01419392

Ahmed-2004

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Sildenafil citrate

Experimental group

Treatment:

Drug: Sildenafil citrate

placebo

Placebo Comparator group

Treatment:

Drug: matching placebo