Fetal Growth Restriction
Conditions
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.
Interventions
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.
DRUGPlacebo Oral Tablet
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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| date of delivery after Sildenafil citrate administration. | for 6 months from the beginning of the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expected fetal weight by serial ultrasound after Sildenafil citrate administration | every two weeks after drug intake for 6 months from the beginning of the study | 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 . |
| Color Doppler changes on umbilical artery | weekly after drug intake for 6 months from the beginning of the study | 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 . |
| neonatal outcomes as regard birth weight | for 6 months from the beginning of the study | 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. |
| neonatal outcomes as regard APGAR score | for 6 months from the beginning of the study | 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. |
Countries
Egypt
Contacts
Primary Contactshaimaa mohamed Ezz el Din, MB ChB
Outcome results
None listed