NCT03230162

Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Fetal Growth Abnormality
• Fetal Growth Restriction

Interventions

Type	Name	Description
DRUG	Sildenafil	sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
DRUG	low molecular weight heparin	a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2017-07-26
• Last updated: 2017-07-26

Locations

1 site across 1 country: Egypt