Sildenafil and Uteroplacental Perfusion

NCT ID: NCT01107782

Last Updated: 2011-02-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fetal growth retardation affects up to 8% of all pregnancies and has massive short term (increased fetal morbidity and mortality) and long-term (increased incidence of cardiovascular disorders in adulthood) health implications.

Doppler waveform analysis of these pregnancies suggests compromised uteroplacental circulation and placental hypoperfusion.

Our aim is to assess if sildenafil citrate could improve vasodilatation in FGR pregnancies.

Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental perfusion in FGR.

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil citrate, may improve uterine blood flow .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fetal Growth Retardation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sildenafil

Group Type EXPERIMENTAL

sildenafil

Intervention Type DRUG

50 mg TDS orally until birth

Placebo control

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

50mg tid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sildenafil

50 mg TDS orally until birth

Intervention Type DRUG

placebo

50mg tid

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

viagra placebo tid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* FGR pregnancies in 24-37 weeks of GA

Exclusion Criteria

* vasodilator agents usage
* history of cardiovascular morbidity specially of right heart side
* drug or alcohol abusers
* systolic BP more than 210 mm Hg or diastolic BP more than 120 mm Hg
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tehran University of Medical Sciences

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

marzieh vahid dastjerdi, M.D.

Role: STUDY_CHAIR

Iranian's ministery of health

Sayedeh Afagh Hosseini, MD.

Role: STUDY_DIRECTOR

resident of OB&GYN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tehran UMS

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iran

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

sayedeh afagh hosseini, M.D.

Role: CONTACT

+989188111670

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

sayedeh afagh hosseini, M.D.

Role: primary

+989188111670

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

87-821

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy of Sildenafil in Preterm Preeclampsia
NCT02782559 WITHDRAWN PHASE2/PHASE3
Viagra for the Treatment of IUGR
NCT00347867 UNKNOWN PHASE4
Sildenafil and Outcome of IVF/ICSI Cycles
NCT03192709 UNKNOWN PHASE1/PHASE2
PK Study of Sildenafil in Neonate
NCT02244528 COMPLETED PHASE2
Safety of Sildenafil in Premature Infants
NCT03142568 COMPLETED PHASE2