Clinical Trial: The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)

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

Official Title: The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)

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 parameters/endpoints: Perinatal healthy survival, i.e. 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 can't be excluded on beforehand.


Detailed Summary:
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Current Primary Outcome: Intact neonatal survival until term age [ Time Frame: Term age, up to 20 weeks after randomization ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fetal growth velocity assessed by ultrasound: abdominal circumference measurements (AC) [ Time Frame: At contact moments with the patient, up to 20 weeks after randomization ]
    Average daily increase in ultrasound-estimated AC
  • Age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score) [ Time Frame: 2 years corrected age, up to 2 years and three months after randomization ]
  • Co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome (Hemolysis Elevated Liver enzymes Low Platelets) [ Time Frame: At contact moments with the patient, up to 20 weeks after randomization ]


Original Secondary Outcome: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: September 29, 2014
Date Started: January 2015
Date Completion: January 2019
Last Updated: July 13, 2016
Last Verified: July 2016