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Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler

NCT04502823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1088

Last updated 2024-02-21

No results posted yet for this study

Summary

Open randomized non-inferiority controlled trial to examine the use of angiogenic factors (instead of feto-placental Doppler) for fetal growth restriction at term to reduce the rate of labor inductions, without worsening perinatal outcomes.

Conditions

  • Fetal Growth Retardation

Interventions

PROCEDURE

Management based on sFlt-1/PlGF values

In women allocated to the intervention group, the sFlt-1/PlGF result will be revealed to the investigators that will act according to the results of sFlt/PlGF: * Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended immediately (within 24h) at ≥37 weeks. * Fetuses with sFlt-1/PlGF \<38 weekly follow up will be recommended and delivery at ≥40 weeks.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Manel Mendoza, PhD · Vall d'hebron Institut de Recerca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2022-12-18
Completion
2022-12-18

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04502823 on ClinicalTrials.gov