DRIGITAT: Doppler Ratio In fetal Growth restriction Intervention Trial At (near) Term

Completed

• Conditions: Fetal growth restriction; fetal growth retardation; 10016849

• Registration Number: NL-OMON55736
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 939

Inclusion Criteria

Inclusion criteria for the cohort:
- Singleton pregnancies with identified SGA fetus (EFW/FAC < p10)
- Gestational age from 32+0 up to and including 36+6 weeks

Inclusion criteria for the nested RCT:
- Singleton pregnancies with identified SGA-fetus (EFW/FAC < p10)
AND
- UCR (UmbilicoCerebral Ratio) > 0.8 on at least 2 occasions with an interval
of at least 15 hours (or - when measurement of PI in the middle cerebral artery
is impossible - the PI of the umbilical artery is > p90 on at least 2 occasions
with an interval of at least 15 hours)
AND
- EFW/FAC < p3 AND 34+0 up to and including 36+6 weeks of gestation
OR
- EFW/FAC < p10 AND 36+0 up to and including 36+6 weeks of gestation

Exclusion Criteria

- Maternal age <18 years
- Inability to give informed consent
- Uncertainty about the expected due date
- Suspicion of congenital anomalies which can influence the prognosis of the
pregnancy or health of the fetus
- Proven chromosomal abnormalities
- Maternal or fetal indication for short-term delivery

Study & Design

• Study Type: Interventional
• Study Design: Not specified