Trial | NCT02277132  Report issue

Official Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    sildenafil ...

  • Study Participants

    216
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.
Study Started
Jan 31
2015
Primary Completion
Jul 19
2018
Study Completion
Jul 19
2018
Last Update
Jul 26
2018

Drug Sildenafil

Sildenafil 25 mg three times daily orally from randomization until delivery

  • Other names: Viagra

Drug Placebo

Placebo tablets three times daily orally from randomization until delivery

Sildenafil Active Comparator

Sildenafil 25 mg tablets three times daily orally from randomization until delivery

Placebo Placebo Comparator

Placebo tablets three times daily orally from randomization until delivery

Criteria 

Inclusion Criteria:

Inclusion criteria ((I OR II) AND III):

At 20+0-27+6 weeks: an ultrasound measurement of the fetal abdominal circumference (AC) <3rd percentile for gestational age or an ultrasound estimate of fetal weight (EFW) <5th percentile OR
At 28+0-29+6 weeks: an ultrasound estimate of fetal weight (EFW) <700 grams using Hadlock C formula AND

Likely placental origin defined by (a AND/OR b AND/OR c AND/OR d)

The presence of uterine artery notching
Abnormal flow velocity patterns of the umbilical artery or middle cerebral artery
Maternal hypertensive disorders
Low PlGF in point-of-care assessment

Exclusion Criteria:

Plan to terminate pregnancy for maternal or fetal indication within days
Known multiple pregnancy
Identified congenital anomalies or congenital infection
Maternal age at eligibility <18 years
Cocaine use
Current use of sildenafil
Current use of cyp3A5 inhibitors: amiodaron, azitromycine, ciclosporine, claritromycine, diltiazem, erytromycine, fluconazol, itraconazol, ketoconazol, verapamil, voriconazol.
Recent myocardial infarction or stroke
No Results Posted