Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

• Status: Unknown status
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Sildenafil Citrate; Tinzaparin

Criteria

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.