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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

Page last updated: August 23, 2015

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