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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03230162
Other study ID # Ain shams university maternity
Secondary ID
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
Health authority
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.

Study Design


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
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