Viagra for the Treatment of IUGR

Phase 4

• Conditions: IUGR

• Registration Number: NCT00347867
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

It has been suggested that Viagra (or other drugs that inhibit PDE-5, the enzyme that normally inhibits blood vessels' ability to expand) may have beneficial effects in hypertensive pregnancy and, possibly, preeclampsia.The benefits of Viagra were observed without any reduction in maternal blood pressure, thereby dissociating hypertension per se from the loss of NO (nitrous oxide) signaling in the uterine circulation.Following publications, suggesting that sildenafil citrate used as a therapeutic agent may improve myometrial perfusion in IUGR gestations by promoting myometrial small artery vasodilatation, decreasing peripheral resistance and increasing flow within the uteroplacental bed, we intend to administer this medication to parturients where intauterine growth restriction and pregnancy associated hypertension have been diagnosed in an attempt to induce vasodilatation and improved uteroplacental perfusion resulting in improved fetal growth.

Detailed Description

Each participant will receive, after informed consent a 25 mg tablet of Viagra \[sildenafil citrate \]orally. The uteroplacental perfusion will be measured using transvaginal and transabdominal ultrasound Doppler velocimetry studies, before and after 2, 4, and 24 hours of Viagra ingestion. If no significant side effects are recorded, the protocol will be repeated , 48 hours after the first tablet ingestion, but using 50 mg Viagra.In cases of positive and encouraging results and if no serious side effects are detected we shall consider repeated administration of the lowest effcetive dose of viagra in an attempt to prevent prematurity and possibly reach term.our study will evaluate the effects of Viagra on uterine blood flow changes during pregnancy, and possible changes in other systems that contribute to normal fetal growth and development, in parallel to monitoring general and possible deleterious effects on the retina or other possible maternal or fetal organs.

Study Timeline

• Status Verified: 2006-06
• Study Start: 2006-07
• Study First Submitted: 2006-07-03
• Study First Submitted QC: 2006-07-03
• Last Update Submitted: 2006-07-03
• Study First Posted: 2006-07-04
• Last Update Posted: 2006-07-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• IUGR/PET/Pregnancy weeks 24-33.
• Informed consent.

Exclusion Criteria

• Maternal cardiovascular morbidity.
• Usage of any vasodilator medication
• Smoking
• Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Uteroplacental perfusion
Fetal growth
Maternal and fetal safety

Trial Locations

Locations (1)

RAMBAM Health Care Campus; 🇮🇱 Haifa, Israel