Status:
COMPLETED
Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Fetal Growth Retardation
Eligibility:
FEMALE
16+ years
Phase:
NA
Brief 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 induction...
Detailed Description
Pregnant women with estimated fetal weight (EFW) \< 10th centile between 36+0 and 37+6 weeks of gestation (WG) will receive complete ultrasonographic assessment consisting of feto-placental Doppler, a...
Eligibility Criteria
Inclusion
- Pregnant women ≥ 16 years of age.
- Singleton pregnancy.
- Ultrasonographic estimated fetal weight \<10th centile.
- Gestational age between 36+0 and 37+6 weeks.
Exclusion
- Major fetal malformations or genetic disorders.
- Fetal death.
- Absent or reverse end-diastolic flow in umbilical artery Doppler or DV PI\>95th centile.
- Non-reassuring cardiotocography (CTG).
- Preeclampsia.
- Diminished fetal movements.
- Biophysical profile ≤ 6.
- Oligohydramnios
- Refusal to give informed consent.
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2022
Estimated Enrollment :
1088 Patients enrolled
Trial Details
Trial ID
NCT04502823
Start Date
September 21 2020
End Date
December 18 2022
Last Update
February 21 2024
Active Locations (20)
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1
Hospital Universitario de A Coruña
A Coruña, Spain
2
Hospital General de Alicante
Alicante, Spain
3
Hospital Germans Trias i Pujol
Badalona, Spain
4
Hospital Universitari Vall d'hebron
Barcelona, Spain