Fetal Growth AbnormalityPhase 3NCT03230162
Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
A Phase 3 study testing Sildenafil and low molecular weight heparin in people with Fetal Growth Abnormality and Fetal Growth Restriction, run by Ain Shams University at 1 site in Egypt.
Trial summary
comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Fetal Growth Abnormality, Fetal Growth Restriction
- What is being tested?
- Sildenafil and low molecular weight heparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 May 2018
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age between 20-35 years.
- Being at a gestational age 28-35wks.
- Singleton pregnancy.
- Fetal growth restriction diagnosed by ultrasound with estimated fetal weight below the 10th percentile, and/or fetal abdominal circumference at or below the tenth percentile.
Who cannot join
- Maternal age less than 20 years or more than 35 years.
- Undetermined gestational age.
- Multiple gestation.
- Chronic diseases with pregnancy e.g. Chronic hypertension, diabetes type 1 or 2.
- Etiologies of FGR other than placental insufficiency as fetal malformations, aneuploidy or infections.
- Suspected fetal compromise requiring emergency delivery.
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- Any contraindication to the use of sildenafil e.g. known significant maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil.
- Any contraindication to the use of LMWH e.g. known bleeding disorder, active antenatal bleeding or at increased risk of major hemorrhage (e.g. placenta praevia), thrombocytopenia, severe renal or hepatic disease.
- Drug or alcohol abuse.
- Patient refusing to participate in the study or unable to consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShams university maternity hospital
Cairo, 02
Radwa R Ali, MD
About this study
comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency
Read the detailed description
One hundred pregnant women with documented intrauterine growth restriction due to placental insufficiency at 28-35 weeks of gestation will be distributed into two groups:
- Group S: 50 women will receive Sildenafil citrate 25 mg tab 3 times daily.
- Group H: 50 women will receive single dose of LMWH subcutaneous daily.
Both groups will undergo strict fetal surveillance in the form of:
Umbilical artery Doppler (UAD) is the primary surveillance tool in the FGR fetus:
middle cerebral artery (MCA) Doppler, ultrasound for (AC, EFW, and deepest vertical pocket (DVP) for amniotic fluid) and non stress test and Biophysical profile (BPP)
- Conditions
- Fetal Growth Abnormality, Fetal Growth Restriction
- Being tested
- Sildenafil, low molecular weight heparin
- 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 Silden EIPICO co.
sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
low molecular weight heparinDrug
Also called tinzaparin, Innohep LEO pharmaceutical products
a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery
| Study group | Role | What they receive |
|---|---|---|
| sildenafil citrate | Experimental | 50 pregnant female will be treated with sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery. Receives: Drug: Sildenafil |
| low molecular weight heparin | Experimental | 50 pregnant female will be treated with a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery according to body weight as follow < 50 kg 3500 units daily 50-90 kg 4500 units daily 91-130 kg 7000 units daily 131-170 kg 9000 units daily > 170 kg 75 u/kg/day Receives: Drug: low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal birth weight in grams
Measured: At time of Delivery
Secondary outcomes (7)
The change in Doppler velocity indices,
Measured: 24 week till 35 weeks
Fetal growth velocity
Measured: weekly till time of delivery
Gestational age at delivery,
Measured: at time of delivery
APGAR score
Measured: at 1 and 5 min of life
Neonatal complication rates
respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion
Measured: The first 28 day of delivery
Neonatal ICU admission rate
Measured: The first 28 day of delivery
the interval between the diagnosis and delivery
Measured: at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Jun 2017
- Primary completion1 May 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth AbnormalityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230162
- Sponsor's protocol ID
- Ain shams university maternity
- Status last verified
- Jul 2017
- First submitted
- 28 May 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
- ClinicalTrials.gov ID
- NCT03230162
- Acronym / sponsor ID
- Ain shams university maternity
- Conditions
- Fetal Growth Abnormality, Fetal Growth Restriction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 26 Jul 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.
comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency
Detailed description
One hundred pregnant women with documented intrauterine growth restriction due to placental insufficiency at 28-35 weeks of gestation will be distributed into two groups:
- Group S: 50 women will receive Sildenafil citrate 25 mg tab 3 times daily.
- Group H: 50 women will receive single dose of LMWH subcutaneous daily.
Both groups will undergo strict fetal surveillance in the form of:
Umbilical artery Doppler (UAD) is the primary surveillance tool in the FGR fetus:
middle cerebral artery (MCA) Doppler, ultrasound for (AC, EFW, and deepest vertical pocket (DVP) for amniotic fluid) and non stress test and Biophysical profile (BPP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildenafil citrate | Experimental | Drug: Sildenafil50 pregnant female will be treated with sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery. |
| low molecular weight heparin | Experimental | Drug: low molecular weight heparin50 pregnant female will be treated with a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery according to body weight as follow < 50 kg 3500 units daily 50-90 kg 4500 units daily 91-130 kg 7000 units daily 131-170 kg 9000 units daily > 170 kg 75 u/kg/day |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Maternal age between 20-35 years.
- Being at a gestational age 28-35wks.
- Singleton pregnancy.
- Fetal growth restriction diagnosed by ultrasound with estimated fetal weight below the 10th percentile, and/or fetal abdominal circumference at or below the tenth percentile.
Key exclusion criteria (10 listed)
- Maternal age less than 20 years or more than 35 years.
- Undetermined gestational age.
- Multiple gestation.
- Chronic diseases with pregnancy e.g. Chronic hypertension, diabetes type 1 or 2.
- Etiologies of FGR other than placental insufficiency as fetal malformations, aneuploidy or infections.
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: Silden EIPICO co.sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery | Drug | sildenafil citrate |
| low molecular weight heparinAlso: tinzaparin, Innohep LEO pharmaceutical productsa single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery | Drug | low molecular weight heparin |
Primary outcome
Neonatal birth weight in grams
Time frame: At time of Delivery
7 secondary outcomes
The change in Doppler velocity indices,
Time frame: 24 week till 35 weeks
Fetal growth velocity
Time frame: weekly till time of delivery
Gestational age at delivery,
Time frame: at time of delivery
APGAR score
Time frame: at 1 and 5 min of life
Neonatal complication rates
Time frame: The first 28 day of delivery
Neonatal ICU admission rate
Time frame: The first 28 day of delivery
the interval between the diagnosis and delivery
Time frame: at time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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 and low molecular weight heparin in people with Fetal Growth Abnormality and 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 4 inclusion and 10 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 26 Jul 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. 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 Radwa R Ali, MD (01283492979 ext. +202, radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal birth weight in grams (time frame: At time of Delivery). 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 26 Jul 2017.