Clinical trial NCT03230162: Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
Official title: Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fetal Growth Abnormality
Fetal Growth Restriction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Neonatal birth weight in grams
timeFrame: At time of Delivery
Secondary outcomes:
measure: The change in Doppler velocity indices,
timeFrame: 24 week till 35 weeks
measure: Fetal growth velocity
timeFrame: weekly till time of delivery
measure: Gestational age at delivery,
timeFrame: at time of delivery
measure: APGAR score
timeFrame: at 1 and 5 min of life
measure: Neonatal complication rates
timeFrame: The first 28 day of delivery
measure: Neonatal ICU admission rate
timeFrame: The first 28 day of delivery
measure: the interval between the diagnosis and delivery
timeFrame: at time of delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
Study officials:
References: