Fetal Growth RestrictionPhase 3NCT03177824
Sildenafil Citrate for Treatment of Growth-restricted Fetuses
A Phase 3 study testing Sildenafil Citrate 25Mg Tab in people with Fetal Growth Restriction, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Fetal Growth Restriction
- What is being tested?
- Sildenafil Citrate 25Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2017to 1 Oct 2017
- Phase
- Phase 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age ranging from 20-40 years.
- Gestational age 28-37 weeks.
Who cannot join
- Obese patients (BMI >30 kg/m2).
- Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
- Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
- Fetal distress.
- Pregnancy of multiple fetuses.
- Congenital fetal malformation or chromosomal abnormalities.
- Diastolic blood pressure more than 110 mmHg.
- Hypersensitivity to the drug.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams matrnity hospital
Cairo
shaimaa mohamed Ezz el Din, MB ChB, +201000484298, dr.shaimaaezz666@gmail.com
About this study
The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.
- Conditions
- Fetal Growth Restriction
- Being tested
- Sildenafil Citrate 25Mg Tab, Placebo Oral Tablet
- 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.
Sildenafil Citrate 25Mg TabDrug
Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
Placebo Oral TabletDrug
Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score
| Study group | Role | What they receive |
|---|---|---|
| S | Experimental | Sildenafil citrate (25mg) Receives: Drug: Sildenafil Citrate 25Mg Tab |
| P | Placebo comparator | placebo oral tablet Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
date of delivery after Sildenafil citrate administration.
the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Measured: for 6 months from the beginning of the study
Secondary outcomes (4)
Expected fetal weight by serial ultrasound after Sildenafil citrate administration
the Expected fetal weight in grams by serial ultrasound is assessed in women with growth redistricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
Measured: every two weeks after drug intake for 6 months from the beginning of the study
Color Doppler changes on umbilical artery
Color Doppler changes on umbilical artery is assessed in women with growth restricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
Measured: weekly after drug intake for 6 months from the beginning of the study
neonatal outcomes as regard birth weight
the study aims to assess neonatal outcomes as regard, birth weight in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Measured: for 6 months from the beginning of the study
neonatal outcomes as regard APGAR score
the study aims to assess neonatal outcomes as regard APGAR score in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Measured: for 6 months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start30 Mar 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ezz el din, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177824
- Sponsor's protocol ID
- 123sc
- Status last verified
- Jun 2017
- First submitted
- 26 Apr 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Citrate for Treatment of Growth-restricted Fetuses
- ClinicalTrials.gov ID
- NCT03177824
- Acronym / sponsor ID
- 123sc
- Conditions
- Fetal Growth Restriction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 6 Jun 2017 (actual)
- 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 aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S | Experimental | Drug: Sildenafil Citrate 25Mg TabSildenafil citrate (25mg) |
| P | Placebo comparator | Drug: Placebo Oral Tabletplacebo oral tablet |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Maternal age ranging from 20-40 years.
- Gestational age 28-37 weeks.
Key exclusion criteria (8 listed)
- Obese patients (BMI >30 kg/m2).
- Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
- Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
- Fetal distress.
- Pregnancy of multiple fetuses.
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 |
|---|---|---|
| Sildenafil Citrate 25Mg TabGroup 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score. | Drug | S |
| Placebo Oral TabletGroup 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score | Drug | P |
Primary outcome
date of delivery after Sildenafil citrate administration.
Time frame: for 6 months from the beginning of the study
the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
4 secondary outcomes
Expected fetal weight by serial ultrasound after Sildenafil citrate administration
Time frame: every two weeks after drug intake for 6 months from the beginning of the study
Color Doppler changes on umbilical artery
Time frame: weekly after drug intake for 6 months from the beginning of the study
neonatal outcomes as regard birth weight
Time frame: for 6 months from the beginning of the study
neonatal outcomes as regard APGAR score
Time frame: for 6 months from the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil Citrate 25Mg Tab in people with Fetal Growth Restriction, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 8 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 9 Jun 2017. 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 Egypt. 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 phase mean?
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 shaimaa mohamed Ezz el Din, MB ChB (+201000484298, dr.shaimaaezz666@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
date of delivery after Sildenafil citrate administration. (time frame: for 6 months from the beginning of the study). 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 9 Jun 2017.