Effectiveness of fetal scalp blood sampling for the prevention of cesarean section in case of suspected fetal distress during labor
- Conditions
- Fetal distress during labor , fetal acidosis, foetale nood,
- Registration Number
- NL-OMON28995
- Lead Sponsor
- Radboud University Nijmegen Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
Inclusion criteria cohort:
1. Informed consent before the beginning of labor;
Exclusion Criteria
Exclusion criteria cohort:
1. Major congenital anomalies;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cesarean section.
- Secondary Outcome Measures
Name Time Method 1. Composite poor perinatal outcome, which includes: Metabolic acidosis at birth (umbilical artery pH < 7.05 + base deficit (full blood) > 12 mmol/l, Severe acidosis at birth (umbilical artery pH < 7.00), Five minute Apgar score < 7, Evidence of hypoxic ischemic encephalopathy (Sarnat stage 2 or 3), Perinatal death during delivery or within 28 days after birth;<br /><br>2. Maternal complications;<br /><br>3. Women's birth experiences.<br><br /><br /><br>A cost effectiveness and budget impact analysis is performed alongside the clinical trial.