Status:
TERMINATED
The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Fetal Growth Restriction
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
PHASE3
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2018
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT02277132
Start Date
January 1 2015
End Date
July 19 2018
Last Update
July 26 2018
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboud Medisch Centrum Nijmegen
Nijmegen, Gelderland, Netherlands, 6525GA
2
Maastricht Universitair Medisch Centrum
Maastricht, Limburg, Netherlands, 6202AZ
3
Maxima Medisch Centrum
Veldhoven, North Brabant, Netherlands, 5504 DB
4
Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, Netherlands, 1081HV