Clinical Trial: Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: STRIDER Canada: A Randomized Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction (Canada)

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 Summary:

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 18+0 and 27+6 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 31+6 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.


Sponsor: University of British Columbia

Current Primary Outcome: compare the gestational age at delivery (d) between sildenafil- and placebo-treated groups [ Time Frame: 6 weeks after postpartum ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • live birth [ Time Frame: at delivery if alive ]
  • survival to hospital discharge [ Time Frame: measured at the final hospital discharge (average upto 6 weeks postpartum) ]
  • intact survival (defined as survival to estimated due date (EDD) without evidence of severe central nervous system [CNS] injury [by ultrasound and/or magnetic resonance imaging (MRI)]) [ Time Frame: measured at estimated due date (EDD) ]
  • composite non-CNS (Central Nervous System) severe morbidity (one/more of bronchopulmonary dysplasia requiring supplemental oxygen on hospital discharge, ≥grade 3 retinopathy of prematurity, or necrotising enterocolitis) [ Time Frame: up to 6 weeks after postpartum or final discharge which ever is sooner ]


Original Secondary Outcome:

  • live birth [ Time Frame: at delivery if alive ]
  • survival to hospital discharge [ Time Frame: measured at the final hospital discharge (average upto 6 weeks postpartum) ]
  • intact survival (defined as survival to estimated due date (EDD) without evidence of severe central nervous system [CNS] injury [by ultrasound and/or magnetic resonance imaging (MRI)]) [ Time Frame: measured at estimated due date (EDD) ]
  • composite non-CNS severe morbidity (one/more of bronchopulmonary dysplasia requiring supplemental oxygen on hospital discharge, ≥grade 3 retinopathy of prematurity, or necrotising enterocolitis) [ Time Frame: up to 6 weeks after postpartum or final discharge which ever is sooner ]


Information By: University of British Columbia

Dates:
Date Received: May 5, 2015
Date Started: January 2017
Date Completion: December 2019
Last Updated: January 11, 2017
Last Verified: January 2017