Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

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

Study Overview

• Status: Unknown
• Conditions: Fetal Growth Restriction; Fetal Growth Abnormality
• Intervention / Treatment: Drug: Sildenafil; Drug: low molecular weight heparin

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)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Recruiting
    • AinShams university maternity hospital
    • Contact: Radwa R Ali, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Sildenafil; sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery; Other Names: Silden EIPICO co.
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 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neonatal birth weight in grams	At time of Delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Doppler velocity indices,		24 week till 35 weeks
Fetal growth velocity		weekly till time of delivery
Gestational age at delivery,		at time of delivery
APGAR score		at 1 and 5 min of life
Neonatal complication rates	respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion	The first 28 day of delivery
Neonatal ICU admission rate		The first 28 day of delivery
the interval between the diagnosis and delivery		at time of delivery

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: July 23, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 23, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Sildenafil Citrate
• Other Study ID Numbers: Ain shams university maternity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No