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The CErebro Placental RAtio as indicator for delivery in perception of reduced fetal movements (CEPRA-study)

The CErebro Placental RAtio as indicator for delivery in perception of reduced fetal movements (CEPRA-study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22934
Enrollment
2160
Registered
2019-02-25
Start date
2020-04-01
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

Reduced fetal movements

Interventions

Expedited delivery is pursued in women with an abnormal CPR (<1.1) in the open study arm. In this case we aim to start delivery within 16 hours or an elective caesarean section will be advanced. Women

Sponsors

University Medical Center of Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancies in cephalic presentation and normal cardiotocograph presenting with RFM beyond 37 weeks gestation

Exclusion criteria

Exclusion criteria: • Small for gestational age, defined as an abdominal circumference <p10 and/or estimated fetal weight <p10; • Planned caesarean delivery, except an elective repeat caesarean delivery; • Abnormal (ultrasound) findings that indicate immediate need for delivery; • Planned delivery within four days of presentation with RFM; • Major congenital malformations or chromosomal abnormalities that can influence pregnancy outcomes chosen for this study; • Unregulated diabetes mellitus; • Maternal age <18 years; • Inability to give informed consent.

Design outcomes

Primary

MeasureTime frame
Composite perinatal outcome: stillbirth and neonatal mortality ( 7 days)

Secondary

MeasureTime frame
• Mild and other neonatal outcomes (hypoglycaemia, hypothermia, admittance to neonatal ward). • Long-term child outcomes (general health, development and behaviour). • Maternal outcomes (health related quality of life, anxiety pre- and postpartum, hypertensive disorders of pregnancy). • Maternal serum markers (PlGF, sFLt-1, and PlGF/sFLt-1 ratio). • Accuracy of standard placental immunohistochemistry.

Contacts

Public ContactDr. Sanne J. Gordijn (PI)

UMC Groningen

cepra@umcg.nl+31(0)50-3614472

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)