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7/26/2018

Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment - Tabular View - ClinicalTrials.gov

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

ICMJE

Study Phase
Study Design

ICMJE

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Condition

ICMJE

Fetal Growth Abnormality
Fetal Growth Restriction

Intervention

ICMJE

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

Study Arms

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.
Intervention: Drug: Sildenafil
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

https://www.clinicaltrials.gov/ct2/show/record/NCT03230162?term=sildenafil%2C+pregnant&rank=1&view=record

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