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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29445

Enrollment

185

Registered

2017-08-14

Start date

2017-12-29

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Fetal growth restrion, foetale groeirestrictie

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: o Inclusion criteria cohort: - Singleton pregnancy - Identified SGA (estimated fetal weight or fetal abdominal circumference below 10th percentile) - 32+0 – 37+0 weeks of gestation o Inclusion in RCT (in addition to the above-mentioned criteria) - Abnormal UmbilicoCerebral Ratio (UCR): ≥0.8 on at least 2 occasions with an interval of at least one day AND - EFW and/or FAC <p3 AND 34+0 – 37+0 weeks of gestation OR - EFW and/or FAC <p10 AND 36+0 – 37+0 weeks of gestation

Exclusion criteria

Exclusion criteria: - Maternal age <18 years - Multiple pregancies - Suspicion of congenital abnormalities

Design outcomes

Primary

Measure	Time frame
7-point average difference MDI/PDI Bayley-III 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.	—

Contacts

Public ContactMaddy Smies

AMC

m.smies@amc.uva.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)