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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55736

Enrollment

939

Registered

2018-01-18

Start date

2018-09-24

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal growth restriction fetal growth retardation

Interventions

Delivery at 36 weeks when UCR is abnormal and fetal growth is mildly abnormal (EFW/FAC p3-p10) and delivery at 34 weeks when UCR is abnormal and fetal growth is severely abnormal (EFW/FAC below p3).

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for the cohort: - Singleton pregnancies with identified SGA fetus (EFW/FAC 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

Exclusion criteria

Exclusion criteria: - Maternal age

Design outcomes

Primary

Measure	Time frame
7-point average difference MDI/PDI Bayley-3 at 2 years	—

Secondary

Measure	Time frame
Composite outcome of neonatal morbidity appropriate for late preterm gestations, perinatal mortality, mode of delivery, maternal quality of life, costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)