Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

NCT ID: NCT03230162

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sildenafil

Intervention Type: DRUG

sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery

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

Group Type: EXPERIMENTAL

low molecular weight heparin

Intervention Type: DRUG

a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery

Interventions

Sildenafil

sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery

Intervention Type: DRUG

low molecular weight heparin

a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery

Intervention Type: DRUG

Other Intervention Names

Silden EIPICO co.; tinzaparin; Innohep LEO pharmaceutical products

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Rasheedy Ali

lecturer of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AinShams university maternity hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Radwa R Ali, MD

Role: CONTACT

radwaebed@yahoo.com

01283492979 ext. +202

Facility Contacts

Radwa R Ali, MD

Role: primary

Other Identifiers

Ain shams university maternity

Identifier Type: -

Identifier Source: org_study_id