Pregnancy Complication
Conditions
Brief summary
To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from growth restriction to support its use later as prolonged therapy in those pregnancies at higher risk for such complication.
Detailed description
Participants were randomized in 1:1 ratio into one of the following drug regime: Group (I): sildenafil citrate group This group consisted of 22 women who received single oral dose of 50 mg sildenafil citrate. Group (II): placebo group This group consisted of 22 women who received single oral dose of placebo. All participants were evaluated by ultrasound once they admitted and again after 2-hours following administration of either of the treatment tablets. One sonographer was allocated to evaluate all mothers included in the study.
Interventions
DRUGsildenafil citrate
single oral dose of 50 mg
OTHERplacebo
single oral dose of placebo tablet
Sponsors
Menoufia University
Al Hayat National Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Patients were admitted to the study based on the following inclusion criteria: 1. Any age and any party. 2. Body mass index between 25 and 35. 3. Singleton pregnancy. 4. Gestational age of 24 weeks or more. Gestational age was established on the basis of menstrual dates and confirmed by first or second trimester ultrasound for booked patients, however, if a difference of \> 7 days or \> 10 days during first or second trimester respectively, then ultrasound value was used. For unbooked patients they still have the chance to be included in our study if they can bring a scan that showed gestational age during the same period mentioned before. 5. Idiopathic intrauterine growth restriction. 6. Intrauterine growth restriction due to maternal malnutrition, maternal medical disorder as anemia, pregnancy induced hypertension, or chronic renal disease. 7. Intrauterine growth restriction due to substance abuse (including smoking). 8. With or without past history of intrauterine growth restriction .
Exclusion criteria
1. Intrauterine growth restriction due to fetal causes as congenital abnormalities, fetal infection, or multiple gestation. 2. Any drug therapy that can affect fetal growth or fetal blood supply. 3. Maternal diseases that contraindicates the use of sildenafil citrate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement of the Doppler indices following treatment | 9 months |
Countries
Egypt
Outcome results
None listed