Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03153215
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2017-05-05
Brief Title:
Sildenafil in Sever Intrauterine Growth Retardation
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IUGR
Brief Summary:
Severe fetal growth restriction FGR complicates approximately 04 of pregnancies and severely increases the risk of perinatal morbidity and mortalitySildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies
Detailed Description:
The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early and late onset intrauterine growth retardationA total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a prospective case control study
Patients will randomly be allocated to two groups with 23 patients in each groupSildenafil citrate therapy may increase the likelihood of increased growth velocity measured by abdominal circumference AC ultrasound for fetuses of pregnancies complicated by severe early-onset IUGR Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 PDE5 which is responsible for degradation of cGMP which results in increased levels of cGMP leading to smooth muscle relaxation Placental disease consequent on deficient uteroplacental blood flow includes FGR pre-eclampsia and placental abruption and has been implicated in more than 50 of iatrogenic premature births For this reason the problem of severe FGR forms a substantial portion of the population that tertiary care centres care
Patients will randomly be allocated to two groups with 23 patients in each groupSildenafil citrate therapy may increase the likelihood of increased growth velocity measured by abdominal circumference AC ultrasound for fetuses of pregnancies complicated by severe early-onset IUGR Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 PDE5 which is responsible for degradation of cGMP which results in increased levels of cGMP leading to smooth muscle relaxation Placental disease consequent on deficient uteroplacental blood flow includes FGR pre-eclampsia and placental abruption and has been implicated in more than 50 of iatrogenic premature births For this reason the problem of severe FGR forms a substantial portion of the population that tertiary care centres care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None