Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.

Official Title
-----------------
Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Conditions
-----------------
Fetal Growth Restriction

Intervention / Treatment
-----------------
* Drug: Sildenafil Citrate 25Mg Tab
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maternal age ranging from 20-40 years. Gestational age 28-37 weeks. Exclusion Criteria: Obese patients (BMI >30 kg/m2). Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss. Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin. Fetal distress. Pregnancy of multiple fetuses. Congenital fetal malformation or chromosomal abnormalities. Diastolic blood pressure more than 110 mmHg. Hypersensitivity to the drug.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S<br>Sildenafil citrate (25mg) | Drug: Sildenafil Citrate 25Mg Tab<br>* Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.<br>|
| Placebo Comparator: P<br>placebo oral tablet | Drug: Placebo Oral Tablet<br>* Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| date of delivery after Sildenafil citrate administration. | the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery. | for 6 months from the beginning of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expected fetal weight by serial ultrasound after Sildenafil citrate administration | the Expected fetal weight in grams by serial ultrasound is assessed in women with growth redistricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery . | every two weeks after drug intake for 6 months from the beginning of the study | 
| Color Doppler changes on umbilical artery | Color Doppler changes on umbilical artery is assessed in women with growth restricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery . | weekly after drug intake for 6 months from the beginning of the study | 
| neonatal outcomes as regard birth weight | the study aims to assess neonatal outcomes as regard, birth weight in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery. | for 6 months from the beginning of the study | 
| neonatal outcomes as regard APGAR score | the study aims to assess neonatal outcomes as regard APGAR score in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery. | for 6 months from the beginning of the study |