Use of Sildenafil Citrate in Management of Mild Pre-eclampsia
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|ClinicalTrials.gov Identifier: NCT03262961|
Recruitment Status : Unknown
Verified August 2017 by Fady Nasef Tous Abdallah, Assiut University.
Recruitment status was: Recruiting
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
- Mild pre-eclampsia represents 75% of cases with pre-eclampsia, possible progression to severe pre-eclampsia makes mild pre-eclampsia a serious problem that requires attention.
- Previous studies have shown that expectant and conservative management of pre-eclampsia in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival.
- Sildenafil citrate has been used for increasing utero-placental perfusion in cases with intrauterine growth restriction, which makes it a promising drug in management of mild pre-eclampsia.
|Condition or disease||Intervention/treatment||Phase|
|Pre-Eclampsia; Mild||Drug: Sildenafil 20 MG Drug: Placebo Oral Tablet||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||- Double blinded, randomized, placebo-controlled trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||- It's a double blinded, randomized, placebo-controlled trial.|
|Official Title:||Use of Sildenafil Citrate in Management of Mild Pre-eclampsia: A Randomized Controlled Trial|
|Actual Study Start Date :||September 15, 2016|
|Estimated Primary Completion Date :||December 15, 2017|
|Estimated Study Completion Date :||January 15, 2018|
Active Comparator: Intervention Group
• The intervention group will be supplied with Sildenafil Citrate (Respatio® 20mg tablets manufactured by Pharma Right Group , Egypt) according to the patient's weight by the rate of (1.5 mg/kg/day) divided into three doses per day ( every 8 hours) till termination of pregnancy.
Drug: Sildenafil 20 MG
Other Name: Sildenafil Citrate 20 mg ( Respatio® 20 mg)
Placebo Comparator: Control Group
- The control group will be supplied with a placebo drug that has the same shape, size and color 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.
Drug: Placebo Oral Tablet
Other Name: Placebo drug
- Gestational age at time of termination and maternal outcome. [ Time Frame: up to 37 weeks of gestation ]Gestational age at time of termination and maternal outcome in terms of whether the disease would progress to severe pre-eclampsia or not.
- Neonatal outcome. [ Time Frame: up to 37 weeks of gestation ]Neonatal outcome in terms of survival and neonatal well-being ( by obtaining the birth weight and the apgar score at 1 and 5 minutes and direct postnatal need to NICU).
- Control of maternal blood pressure. [ Time Frame: up to 37 weeks of gestation ]Control of maternal blood pressure.
- Method of termination of pregnancy. [ Time Frame: up to 37 weeks of gestation ]Method of termination of pregnancy.
- Identification of the side effects from the use of sildenafil citrate. [ Time Frame: up to 37 weeks of gestation ]Identification of possible maternal side effects from the use of sildenafil citrate i.e.; headache, flushing and dyspepsia.
- Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound. [ Time Frame: up to 37 weeks of gestation ]Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262961
|Contact: Fady Abdallahemail@example.com|
|Contact: Hisham Abou-Talebfirstname.lastname@example.org|
|Assiut Univeristy Hospitals||Recruiting|
|Assiut, Egypt, 71111|
|Contact: Abdallah Hamed 01002621430 email@example.com|
|Principal Investigator:||Fady Abdallah||Assiut University|
|Study Director:||Hasan Kamel||Assiut University|
|Study Director:||Hisham Abou-Taleb||Assiut University|