Status:
NOT_YET_RECRUITING
Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Instituto de Salud Carlos III
Roche Diagnostics GmbH
Conditions:
Fetal Growth Retardation
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a multicentre, open-label, randomized controlled trial. A total of 340 singleton pregnancies with an EFW ≤10th percentile between 26+0 and 31+6 weeks will be recruited and randomly allocated t...
Eligibility Criteria
Inclusion
- Pregnant women of at least 18 years old
- Singleton pregnancy
- Ultrasonographic EFW ≤10th percentile between 26+0 and 31+6 weeks of gestation
- Gestational age confirmed by fetal crown-rump length measurement during the first trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates.
Exclusion
- Major fetal malformations or genetic disorders
- Fetal death
- Refusal to give informed consent
- Stage IV FGR
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT05284474
Start Date
June 3 2024
End Date
December 30 2026
Last Update
June 4 2024
Active Locations (27)
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1
Complejo Hospitalario Universitario de A Coruña
A Coruña, Spain
2
Hospital Universitario General de Alicante
Alicante, Spain
3
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
4
Vall d'hebron Barcelona Hospital Campus
Barcelona, Spain, 08035