Fetal Growth RetardationPhase 2/3NCT01107782
Sildenafil and Uteroplacental Perfusion
A Phase 2/3 study testing sildenafil in people with Fetal Growth Retardation, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Jun 2008to Jan 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- FGR pregnancies in 24-37 weeks of GA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Tehran UMS
Tehran, Tehran Province
sayedeh afagh hosseini, M.D., +989188111670, afahoss@yahoo.com
Marzieh Vahid Dastjerdi, MD.
About this study
Official title: Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil
The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.
Read the 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 .
- Conditions
- Fetal Growth Retardation
- Being tested
- sildenafil, placebo
- Keywords
- sildenafil, FGR
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
Also called viagra
50 mg TDS orally until birth
placeboDrug
Also called placebo tid
50mg tid
| Study group | Role | What they receive |
|---|---|---|
| sildenafil | Experimental | Not described Receives: Drug: sildenafil |
| Placebo control | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uteroplacental Perfusion
Measured: 2 hours after sildenafil ingestion
Secondary outcomes (3)
fetal growth
Measured: after 6 months
umbilical artery blood gass assessment
Measured: immediately after birth
effect on fetal well being
when BP score is<8 we repeat it after sildenafil ingestion
Measured: 2 hours after sildenafil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2010 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- marzieh vahid dastjerdi, M.D., Study chair, Iranian's ministery of healthSayedeh Afagh Hosseini, MD., Study director, resident of OB&GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107782
- Sponsor's protocol ID
- 87-821
- Status last verified
- Feb 2011
- First submitted
- 13 Jan 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil
- ClinicalTrials.gov ID
- NCT01107782
- Acronym / sponsor ID
- 87-821
- Conditions
- Fetal Growth Retardation
- Keywords
- sildenafil, FGR
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildenafil | Experimental | Drug: sildenafil |
| Placebo control | Placebo comparator | Drug: placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- FGR pregnancies in 24-37 weeks of GA
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafilAlso: viagra50 mg TDS orally until birth | Drug | sildenafil |
| placeboAlso: placebo tid50mg tid | Drug | Placebo control |
Primary outcome
Uteroplacental Perfusion
Time frame: 2 hours after sildenafil ingestion
3 secondary outcomes
fetal growth
Time frame: after 6 months
umbilical artery blood gass assessment
Time frame: immediately after birth
effect on fetal well being
Time frame: 2 hours after sildenafil
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marzieh vahid dastjerdi, M.D. study chair
Iranian's ministery of health
Sayedeh Afagh Hosseini, MD. study director
resident of OB&GYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sildenafil in people with Fetal Growth Retardation, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sayedeh afagh hosseini, M.D. (+989188111670, afahoss@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uteroplacental Perfusion (time frame: 2 hours after sildenafil ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.