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Viagra for the Treatment of IUGR

NCT ID: NCT00347867

Last Updated: 2006-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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IUGR

Keywords

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IUGR PET Pregnancy Viagra Sildenafil citrate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Viagra administration in IUGR/PET pregnancies

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Maternal cardiovascular morbidity.
* Usage of any vasodilator medication
* Smoking
* Diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Principal Investigators

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Zeev Blumenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

RAMBAM Health Care Campus, Technion

Locations

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RAMBAM Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Zeev Blumenfeld, MD

Role: CONTACT

Phone: 972-4-8542577

Email: [email protected]

Facility Contacts

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Zeev Blumenfeld, MD

Role: primary

Other Identifiers

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Viagra.CTIL

Identifier Type: -

Identifier Source: org_study_id