The Cerebro Placental Ratio as indicator for delivery in perception of reduced fetal movements.

The Cerebro Placental Ratio as indicator for delivery in perception of reduced fetal movements. - CEPRA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54778

Enrollment

1260

Registered

2019-12-17

Start date

2020-07-01

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

Decreased fetal movements Reduced fetal movements

Interventions

Unblinded arm: in case the CPR is abnormal start of labour within 16 hours is pursued. If the CPR in the unblinded arm is normal monitoring and management according to local protocol will follow, us

the CPR value is unknown, treatment decisions and intervention is not based on the CPR measurement. Monitoring and management is continued according to local protocol. Usually referral back to routi

Eligibility

Inclusion criteria

Inclusion criteria: - Singleton pregnancies with reduced fetal movements - Gestational age 37+0 up to and including 40+6 weeks - Cephalic presentation - Normal CTG

Exclusion criteria

Exclusion criteria: - Small for gestational age - Other indications for immediate delivery - Incomplete CPR measurement

Design outcomes

Primary

Measure	Time frame
Composite severe adverse neonatal outcome of morbidity and mortality.	—

Secondary

Measure	Time frame
1. Mild neonatal morbidity 2. Long-term outcome 3. Maternal morbidity and health related quality of life anxiety ante- and postpartum 4. Cost effectiveness 5. Serum biomarkers 6. Standard placental immunohistochemistry	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)