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van CCT (UK)

van CCT (UK)

Does Sildenafil improve the neonatal prognosis in severe early onset growth restriction?

- candidate number19299
- NTR NumberNTR4751
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-aug-2014
- Secondary IDsNL41894.018.14 
- Public TitleDoes Sildenafil improve the neonatal prognosis in severe early onset growth restriction?
- Scientific TitleThe Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction)
- hypothesisSildenafil citrate increases the likelihood of intact neonatal survival until term age for fetuses of pregnancies complicated by severe early-onset fetal growth restriction.
- Healt Condition(s) or Problem(s) studiedFetal growth retardation, Intra uterine growth retardation/restriction
- Inclusion criteriaInclusion criteria ((I OR II) AND III):
I. 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
II. At 28+0-29+6 weeks: an ultrasound estimate of fetal weight (EFW) <700 grams using Hadlock C formula
III. Likely placental origin defined by (a AND/OR b AND/OR c AND/OR d)
a. The presence of uterine artery notching
b. Abnormal flow velocity patterns of the umbilical artery or middle cerebral artery
c. Maternal hypertensive disorders
d. Low PlGF in point-of-care assessment
- Exclusion criteriaI. Plan to terminate pregnancy for maternal or fetal indication within days
II. Known multiple pregnancy
III. Identified congenital anomalies or congenital infection
IV. Maternal age at eligibility <18 years
V. Cocaine use
VI. Current use of sildenafil
VII. Current use of cyp3A5 inhibitors: amiodaron, azitromycine, ciclosporine, claritromycine, diltiazem, erytromycine, fluconazol, itraconazol, ketoconazol, verapamil, voriconazol.
VIII. Recent myocardial infarction or stroke
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-sep-2017
- Target number of participants354
- InterventionsSildenafil 25 mg or look-alike placebo tablets three times daily orally from randomization until delivery
- Primary outcomeIntact neonatal survival until term age
- Secondary outcome1) To evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of improved fetal growth velocity assessed by ultrasound abdominal circumference measurements (AC);
2) To evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score);
3) To assess co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome
- TimepointsTerm age, at discharge, at two years age (Bayley scales of infant development (BSID)-III)
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryRationale: 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.
- Main changes (audit trail)
- RECORD13-aug-2014 - 19-sep-2014

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