Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Fetal Growth Abnormality; Fetal Growth Restriction

Treatments: Drug: low molecular weight heparin; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT03230162

Ain shams university maternity

Details and patient eligibility

About

comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency

Full 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)

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

sildenafil citrate

Experimental group

Description:

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.

Treatment:

Drug: Sildenafil

low molecular weight heparin

Experimental group

Description:

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

Treatment:

Drug: low molecular weight heparin