Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

Fetal Growth Restriction Clinical Trial

Official title:

Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03230162
• Other study ID #: Ain shams university maternity
• Status: Recruiting
• Phase: Phase 3
• First received: May 28, 2017
• Last updated: July 23, 2017
• Start date: June 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2017
• Source: Ain Shams University
• Contact: Radwa R Ali, MD
• Phone: 01283492979
• Email: radwaebed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Growth Abnormality
• Fetal Growth Restriction
• Fetal Growth Retardation

Intervention

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

Locations

Country	Name	City	State
Egypt	AinShams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal birth weight in grams		At time of Delivery
Secondary	The change in Doppler velocity indices,		24 week till 35 weeks
Secondary	Fetal growth velocity		weekly till time of delivery
Secondary	Gestational age at delivery,		at time of delivery
Secondary	APGAR score		at 1 and 5 min of life
Secondary	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
Secondary	Neonatal ICU admission rate		The first 28 day of delivery
Secondary	the interval between the diagnosis and delivery		at time of delivery