Viagra for the Treatment of IUGR
Primary Purpose
IUGR
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Viagra administration in IUGR/PET pregnancies
Sponsored by
About this trial
This is an interventional treatment trial for IUGR focused on measuring IUGR, PET, Pregnancy, Viagra, Sildenafil citrate
Eligibility Criteria
Inclusion Criteria: IUGR/PET/Pregnancy weeks 24-33. Informed consent. Exclusion Criteria: Maternal cardiovascular morbidity. Usage of any vasodilator medication Smoking Diabetes
Sites / Locations
- RAMBAM Health Care Campus
Outcomes
Primary Outcome Measures
Uteroplacental perfusion
Fetal growth
Maternal and fetal safety
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00347867
Brief Title
Viagra for the Treatment of IUGR
Official Title
Improvement of Utero-Placental Perfusion and Fetal Growth in IUGR and PET by Administration of Sildenafil Citrate in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IUGR
Keywords
IUGR, PET, Pregnancy, Viagra, Sildenafil citrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Viagra administration in IUGR/PET pregnancies
Primary Outcome Measure Information:
Title
Uteroplacental perfusion
Title
Fetal growth
Title
Maternal and fetal safety
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
IUGR/PET/Pregnancy weeks 24-33.
Informed consent.
Exclusion Criteria:
Maternal cardiovascular morbidity.
Usage of any vasodilator medication
Smoking
Diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeev Blumenfeld, MD
Phone
972-4-8542577
Email
z_blumenfeld@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeev Blumenfeld, MD
Organizational Affiliation
RAMBAM Health Care Campus, Technion
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAMBAM Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeev Blumenfeld, MD
Phone
972-4-8542577
Email
z_blumenfeld@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Zeev Blumenfeld, MD
12. IPD Sharing Statement
Learn more about this trial
Viagra for the Treatment of IUGR
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