Sildenafil and Uteroplacental Perfusion | NCT01107782

Studies
Sildenafil and Uteroplacental Perfusion

NCT01107782

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

Feb 23, 2011Estimated

Enrollment

70Estimated

Phase

Phase 2Phase 3

Conditions

Fetal Growth Retardation

Interventions

sildenafil
placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2010Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Jan 13, 2010

First Submission Date that Met QC Criteria

Apr 20, 2010

First Posted Date

Apr 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2011

Last Update Posted Date

Feb 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sildenafil	Experimental		Drug: sildenafil
Placebo control	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sildenafil	Drug	50 mg TDS orally until birth	sildenafil	viagra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uteroplacental Perfusion		2 hours after sildenafil ingestion

Secondary Outcomes

Measure	Description	Time Frame
fetal growth		after 6 months
umbilical artery blood gass assessment		immediately after birth
effect on fetal well being

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sayedeh afagh hosseini, M.D.	Contact	+989188111670		afahoss@yahoo.com

Overall Officials

Name	Affiliation	Role
marzieh vahid dastjerdi, M.D.	Iranian's ministery of health	Study Chair
Sayedeh Afagh Hosseini, MD.	resident of OB&GYN	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tehran UMS	Recruiting	Tehran	Tehran Province		Iran

Condition Browse Module

MeSH Terms

ID	Term
D005317	Fetal Growth Retardation

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068677	Sildenafil Citrate

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided