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Viagra for the Treatment of IUGR

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Information provided by:
Rambam Health Care Campus Identifier:
First received: July 3, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
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.

Condition Intervention Phase
IUGR Drug: Viagra administration in IUGR/PET pregnancies Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Utero-Placental Perfusion and Fetal Growth in IUGR and PET by Administration of Sildenafil Citrate in Pregnancy

Resource links provided by NLM:

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Uteroplacental perfusion
  • Fetal growth
  • Maternal and fetal safety

Estimated Enrollment: 20
Study Start Date: July 2006
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.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Maternal cardiovascular morbidity.
  • Usage of any vasodilator medication
  • Smoking
  • Diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00347867

Contact: Zeev Blumenfeld, MD 972-4-8542577

RAMBAM Health Care Campus Not yet recruiting
Haifa, Israel, 31096
Contact: Zeev Blumenfeld, MD    972-4-8542577   
Principal Investigator: Zeev Blumenfeld, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Zeev Blumenfeld, MD RAMBAM Health Care Campus, Technion
  More Information Identifier: NCT00347867     History of Changes
Other Study ID Numbers: Viagra.CTIL
Study First Received: July 3, 2006
Last Updated: July 3, 2006

Keywords provided by Rambam Health Care Campus:
Sildenafil citrate

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on September 21, 2017