Ignite Creation Date:
2024-05-06 @ 4:03 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02442492
Status:
TERMINATED
Last Update Posted:
2020-02-11
First Post:
2015-05-05
Brief Title:
Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
STRIDER Canada A Randomized Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction Canada
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial terminated following Dutch DSMB recommendation for their Study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRIDERCan
Brief Summary:
Early-onset placental intrauterine growth restriction EO IUGR is associated with a high risk of perinatal morbidity and mortality In association with reduced circulating placental growth factor PlGF EO IUGR results from abnormal placentation with inadequate remodelling of the maternal uteroplacental arteries There is no known treatment for placental IUGR Management involves intensive fetal surveillance with delivery with evidence of serious fetal compromise However remote from term delivery is associated with significant perinatal mortality and morbidity Sildenafil vasodilates the uteroplacental vessels of IUGR-affected pregnancies and may represent a novel therapy
Detailed Description:
STRIDER Canada is one of a consortium of STRIDER randomised controlled trials RCTs each of which is designed to determine whether or not maternal treatment with oral sildenafil citrate improves perinatal outcomes in pregnancies complicated by EO IUGR without increasing risks to the mother
STRIDER Canada is designed as investigator-initiated double-blind randomised placebo-controlled trial of 90 women with a diagnosis of early-onset intrauterine growth restriction with an intention-to-treat analysis 90 Women with affected pregnancies will be recruited and randomised to receive either sildenafil or placebo
Women reviewed in the participating fetal medicine with a diagnosis of a pregnancy affected by early-onset IUGR between 180 and 276 weeks of gestation and serum PlGF levels less than 5th percentile for gestational age will be considered for randomisation In Canadian STRIDER the treatment with either sildenafil or placebo 25 mg 3 times per day will be applied from the time of randomisation until delivery or up to 316 weeks of gestation whichever comes first
All patients randomly assigned to one of the treatments will be analysed together regardless of whether or not they completed or received that treatment on an intention to treat basis
STRIDER Canada is designed as investigator-initiated double-blind randomised placebo-controlled trial of 90 women with a diagnosis of early-onset intrauterine growth restriction with an intention-to-treat analysis 90 Women with affected pregnancies will be recruited and randomised to receive either sildenafil or placebo
Women reviewed in the participating fetal medicine with a diagnosis of a pregnancy affected by early-onset IUGR between 180 and 276 weeks of gestation and serum PlGF levels less than 5th percentile for gestational age will be considered for randomisation In Canadian STRIDER the treatment with either sildenafil or placebo 25 mg 3 times per day will be applied from the time of randomisation until delivery or up to 316 weeks of gestation whichever comes first
All patients randomly assigned to one of the treatments will be analysed together regardless of whether or not they completed or received that treatment on an intention to treat basis
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