Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
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|ClinicalTrials.gov Identifier: NCT03230162|
Recruitment Status : Unknown
Verified July 2017 by Radwa Rasheedy Ali, Ain Shams University.
Recruitment status was: Recruiting
First Posted : July 26, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fetal Growth Abnormality Fetal Growth Restriction||Drug: Sildenafil Drug: low molecular weight heparin||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||May 1, 2018|
|Estimated Study Completion Date :||May 1, 2018|
Experimental: sildenafil citrate
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.
sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
Other Name: Silden EIPICO co.
Experimental: low molecular weight heparin
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
Drug: low molecular weight heparin
a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery
- Neonatal birth weight in grams [ Time Frame: At time of Delivery ]
- 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 ]respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230162
|Contact: Radwa R Ali, MD||01283492979 ext +firstname.lastname@example.org|
|AinShams university maternity hospital||Recruiting|
|Cairo, Egypt, 02|
|Contact: Radwa R Ali, MD|