Not Yet RecruitingNot Applicable

Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler

Spain340 participantsStarted 2024-06-03

Plain-language 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 to either the control or the intervention group. In the control group, standard Doppler-based management will be used. In the intervention group, different soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) cutoffs will be incorporated to the current protocol to adjust the frequency of ultrasounds and to plan elective delivery.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Major fetal malformations or genetic disorders * Fetal death * Refusal to give informed consent * Stage IV FGR

What they're measuring

Fetal and Neonatal complications

Timeframe: During pregnancy and up to 28 days after delivery

Composite adverse maternal outcome

Timeframe: During pregnancy and up to 28 days after delivery

Trial details

NCT IDNCT05284474

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Manel Mendoza, MD, PhD

+34934893000 manel.mendoza@vallhebron.cat

View on ClinicalTrials.gov More Fetal Growth Retardation trials