NCT01107782

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2008

Typical duration for phase_2

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

June 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

2 years

First QC Date

January 13, 2010

Last Update Submit

February 22, 2011

Conditions

Fetal Growth Retardation

Keywords

sildenafilFGR

Outcome Measures

Primary Outcomes (1)

  • Uteroplacental Perfusion

    2 hours after sildenafil ingestion

Secondary Outcomes (3)

  • fetal growth

    after 6 months

  • umbilical artery blood gass assessment

    immediately after birth

  • effect on fetal well being

    2 hours after sildenafil

Study Arms (2)

sildenafil

EXPERIMENTAL
Drug: sildenafil

Placebo control

PLACEBO COMPARATOR
Drug: placebo

Interventions

sildenafilDRUG

50 mg TDS orally until birth

Also known as: viagra
sildenafil
placeboDRUG

50mg tid

Also known as: placebo tid
Placebo control

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • FGR pregnancies in 24-37 weeks of GA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran UMS

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • marzieh vahid dastjerdi, M.D.

    Iranian's ministery of health

    STUDY CHAIR

  • Sayedeh Afagh Hosseini, MD.

    resident of OB&GYN

    STUDY DIRECTOR

Central Study Contacts

sayedeh afagh hosseini, M.D.

CONTACT

+989188111670afahoss@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

April 21, 2010

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

January 1, 2012

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

IR(1)