Egypt 2017b.
Trial name or title | Use of sildenafil citrate in management of mild pre‐eclampsia. ClinicalTrials.gov Identifier: NCT03262961. |
Methods | Double‐blinded, randomised, placebo‐controlled trial. |
Participants | Target: 80 women Uncomplicated mild pre‐eclampsia at 28 to 36 weeks' gestation with singleton viable pregnancy (age: 18 to 35 years). |
Interventions | Treatment arm: sildenafil citrate (Respatio® 20 mg tablets manufactured by Pharma Right Group, Egypt) divided into 3 doses per day (every 8 hours) till termination of pregnancy. Control arm: a placebo drug that has the same shape, size and colour but without the active ingredient and it would also be taken in a similar way. The placebo tablet will be manufactured at the faculty of pharmacy, Assiut University. |
Outcomes | Primary outcomes: gestational age at time of termination and progression to severe pre‐eclampsia. Secondary outcomes: neonatal survival, birthweight, Apgar score at 1 and 5 minutes and direct postnatal need to NICU, maternal BP, method of termination of pregnancy, side‐effects (headache, flushing and dyspepsia), evaluation of the effect of sildenafil citrate on the feto‐maternal circulation through the Doppler ultrasound. |
Starting date | September 15, 2016 |
Contact information | Contact: Fady Abdallah (00201002837042) fady.nasif@yahoo.com
Contact: Hisham Abou‐Taleb (00201003332139) hishamaboutaleb1@yahoo.com Assiut University. |
Notes | Ongoing. |