The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)
Information source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fetal Growth Restriction
Intervention: Sildenafil (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Official(s) and/or principal investigator(s): J.W. Ganzevoort, MD PhD, Principal Investigator, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) K Bloemenkamp, MD PhD, Study Chair, Affiliation: Leids Universitair Medisch Centrum P von Dadelszen, Prof, Study Chair, Affiliation: University of British Columbia C de Groot, Prof, Study Chair, Affiliation: VU Medisch Centrum M.W. de Laat, MD PhD, Study Chair, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) B.W. Mol, Prof, Study Chair, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) M. Porath, MD PhD, Study Chair, Affiliation: Perinataal Centrum MMC Veldhoven J.A.M. van der Post, Prof, Study Chair, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) A. van Wassenaer, MD PhD, Study Chair, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall contact: J.W. Ganzevoort, MD PhD, Phone: 0031205663454
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.
Clinical Details
Official title: The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Intact neonatal survival until term age
Secondary outcome: Fetal growth velocity assessed by ultrasound: abdominal circumference measurements (AC)Age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score) Co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome (Hemolysis Elevated Liver enzymes Low Platelets)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
J.W. Ganzevoort, MD PhD, Phone: 0031205663454
Universitair Medisch Centrum Groningen, Groningen 9713GZ, Netherlands; Recruiting A Elvan-Taspinar, Phone: 0031503616161
Universitair Medisch Centrum Utrecht, Utrecht 3584CX, Netherlands; Not yet recruiting JB Derks, Phone: 0031887555555
Radboud Medisch Centrum Nijmegen, Nijmegen, Gelderland 6525GA, Netherlands; Recruiting J Van Drongelen, Phone: 0031243611111
Maastricht Universitair Medisch Centrum, Maastricht, Limburg 6202AZ, Netherlands; Not yet recruiting S Al-Nasiry, Phone: 0031433876543
Maxima Medisch Centrum, Veldhoven, Noord Brabant 5504 DB, Netherlands; Not yet recruiting M Porath, Phone: 003140888 80 00
Academisch Medisch Centrum, Amsterdam, Noord Holland 1105AZ, Netherlands; Recruiting Wessel Ganzevoort, MD PhD, Phone: 0031205663769, Email: j.w.ganzevoort@amc.uva.nl Wessel Ganzevoort, MD PhD, Principal Investigator
Vrije Universiteit Medisch Centrum, Amsterdam, Noord Holland 1081HV, Netherlands; Recruiting C Bax, Phone: 0031204444444
Isala Klinieken, Zwolle, Overijssel 8025 AB, Netherlands; Not yet recruiting J van Eyck, Phone: 0031384245000
Leids Universitair Medisch Centrum, Leiden, Zuid Holland 2333ZA, Netherlands; Not yet recruiting K Bloemenkamp, Phone: 0031715269111
Erasmus Medisch Centrum Rotterdam, Rotterdam, Zuid Holland 3015CE, Netherlands; Not yet recruiting JJ Duvekot, Phone: 0031107040704
Additional Information
Starting date: January 2015
Last updated: June 23, 2015
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