NCT00347867

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 4, 2006

Status Verified

June 1, 2006

First QC Date

July 3, 2006

Last Update Submit

July 3, 2006

Conditions

IUGR

Keywords

IUGRPETPregnancyViagraSildenafil citrate

Outcome Measures

Primary Outcomes (3)

  • Uteroplacental perfusion

  • Fetal growth

  • Maternal and fetal safety

Interventions

Viagra administration in IUGR/PET pregnanciesDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAMBAM Health Care Campus

Haifa, 31096, Israel

Location

Study Officials

  • Zeev Blumenfeld, MD

    RAMBAM Health Care Campus, Technion

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeev Blumenfeld, MD

CONTACT

972-4-8542577z_blumenfeld@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

July 1, 2006

Last Updated

July 4, 2006

Record last verified: 2006-06

Locations

IL(1)