Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02277132
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2014-09-29
Brief Title:
The Dutch STRIDER Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
The Dutch STRIDER Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Results of interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRIDER
Brief Summary:
Rationale Severe early-onset fetal growth restriction FGR due to placental insufficiency is associated with a high risk of perinatal morbidity with long-lasting sequelae and mortality Placental insufficiency is the result of abnormal formation and function of the placenta placentation with inadequate remodelling of the maternal spiral uteroplacental arteries There is currently no therapy available with demonstrated effectiveness Evidence suggests Sildenafil citrate improves uteroplacental blood flow growth and meaningful outcomes
Objective To evaluate the effectiveness of sildenafil versus placebo in achieving healthy perinatal survival
Study design Multicenter nationwide randomized placebo-controlled clinical trial
Study population Women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin and with estimated significant likelihood of perinatal death
Intervention Sildenafil 25mg or placebo tablet orally three times daily Main study parametersendpoints Perinatal healthy survival ie survival without severe neonatal morbidity at term age
Nature and extent of the burden and risks associated with participation benefit and group relatedness Taking tablets three times daily No additional ultrasounds other than standard clinical protocol one extra blood sample at inclusion No risks anticipated unexpected medication-associated risks cant be excluded on beforehand
Objective To evaluate the effectiveness of sildenafil versus placebo in achieving healthy perinatal survival
Study design Multicenter nationwide randomized placebo-controlled clinical trial
Study population Women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin and with estimated significant likelihood of perinatal death
Intervention Sildenafil 25mg or placebo tablet orally three times daily Main study parametersendpoints Perinatal healthy survival ie survival without severe neonatal morbidity at term age
Nature and extent of the burden and risks associated with participation benefit and group relatedness Taking tablets three times daily No additional ultrasounds other than standard clinical protocol one extra blood sample at inclusion No risks anticipated unexpected medication-associated risks cant be excluded on beforehand
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