Ignite Creation Date:
2024-05-06 @ 8:07 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02678221
Status:
UNKNOWN
Last Update Posted:
2016-02-09
First Post:
2016-02-05
Brief Title:
Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Intrauterine growth restriction IUGR is defined as fetal abdominal circumference AC or estimated fetal weight EFW 10th centile In asymmetrical IUGR the parameter classically affected is the abdominal circumference AC Fetal growth restriction FGR complicates approximately 04 of pregnancies and severely increases the risk of perinatal morbidity and mortality This is particularly due to premature delivery both for fetal and for secondary maternal indications such as the development of pre-eclampsia
Consequence of deficient uteroplacental blood flow including IUGR pre-eclampsia and placental abruption have been implicated in more than 50 of iatrogenic premature births For this reason the problem of severe IUGR forms a substantial portion of the population that tertiary care centres care for
The effect of early-onset IUGR is particularly significant of those born alive less than a third will survive their neonatal intensive care unit NICU stay without significant neurodevelopmental sequelae Survival rates for severely growth-restricted fetuses very remote from term 28 weeks gestation vary from 7 to 33
As these early-onset IUGR children are born very preterm there are significant risks of neonatal mortality major and minor morbidity and long-term health sequelae
The use of ultrasound Doppler waveform analysis in pregnancies complicated by IUGR suggests compromised uteroplacental circulation and placental hypoperfusion Currently there are no specific evidence-based therapies for placental insufficiency and severe IUGR Non-specific interventions include primarily lifestyle modifications such as reducing or stopping work stopping aerobic exercise rest at home and hospital admission for rest and surveillance These interventions which are not supported by evidence from randomized trials are used in the belief that rest will enhance the uteroplacental circulation at the expense of that to the glutei and quadriceps muscles
There is evidence from ex vivo and animal models of growth restriction that the phosphodiesterase 5 inhibitor sildenafil citrate increases average birth weight and improves uteroplacental blood flow umbilical artery uterine artery
Consequence of deficient uteroplacental blood flow including IUGR pre-eclampsia and placental abruption have been implicated in more than 50 of iatrogenic premature births For this reason the problem of severe IUGR forms a substantial portion of the population that tertiary care centres care for
The effect of early-onset IUGR is particularly significant of those born alive less than a third will survive their neonatal intensive care unit NICU stay without significant neurodevelopmental sequelae Survival rates for severely growth-restricted fetuses very remote from term 28 weeks gestation vary from 7 to 33
As these early-onset IUGR children are born very preterm there are significant risks of neonatal mortality major and minor morbidity and long-term health sequelae
The use of ultrasound Doppler waveform analysis in pregnancies complicated by IUGR suggests compromised uteroplacental circulation and placental hypoperfusion Currently there are no specific evidence-based therapies for placental insufficiency and severe IUGR Non-specific interventions include primarily lifestyle modifications such as reducing or stopping work stopping aerobic exercise rest at home and hospital admission for rest and surveillance These interventions which are not supported by evidence from randomized trials are used in the belief that rest will enhance the uteroplacental circulation at the expense of that to the glutei and quadriceps muscles
There is evidence from ex vivo and animal models of growth restriction that the phosphodiesterase 5 inhibitor sildenafil citrate increases average birth weight and improves uteroplacental blood flow umbilical artery uterine artery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None