The CErebro Placental RAtio as indicator for delivery in perception of reduced fetal movements (CEPRA-study)
Recruiting
- Conditions
- Reduced fetal movements
- Registration Number
- NL-OMON22934
- Lead Sponsor
- niversity Medical Center of Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2160
Inclusion Criteria
Singleton pregnancies in cephalic presentation and normal cardiotocograph presenting with RFM beyond 37 weeks gestation
Exclusion Criteria
•Small for gestational age, defined as an abdominal circumference •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite perinatal outcome: stillbirth and neonatal mortality (< 28 days), NICU admittance longer than 12 hours, APGAR score < 7 at 5 min, pH < 7.10 umbilical artery, emergency delivery for fetal distress, severe neonatal morbidity (respiratory distress syndrome (RDS), hypoxic ischemic encephalopathy (HIE), sepsis, necrotizing enterocolitis (NEC), supplementary oxygen therapy (> 7 days)
- Secondary Outcome Measures
Name Time Method • Mild and other neonatal outcomes (hypoglycaemia, hypothermia, admittance to neonatal ward).<br>• Long-term child outcomes (general health, development and behaviour).<br>• Maternal outcomes (health related quality of life, anxiety pre- and postpartum, hypertensive disorders of pregnancy).<br>• Maternal serum markers (PlGF, sFLt-1, and PlGF/sFLt-1 ratio).<br>• Accuracy of standard placental immunohistochemistry.<br>