Effectiveness of fetal scalp blood sampling for the prevention of cesarean section in case of suspected fetal distress during labor (SCALP-trial); a randomized controlled multicenter study

Withdrawn

Conditions: fetal asphyxia
fetal compromise
fetal distress
10010273

Registration Number: NL-OMON37995

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 230

Inclusion Criteria

- Singleton fetus in vertex position
- Gestational age * 36.0 weeks
- Absence of contraindications for fetal scalp blood sampling (e.g. HIV, hemophilia)
- First stage of labor (e.g. dilatation > 2 cm and/or presenting part > Hodge 1)
- Abnormal CTG (FIGO/STAN criteria)
- Absence of acute fetal compromise (e.g. pre terminal CTG)

Exclusion Criteria

Major congenital anomalies

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the CS rate for all indications.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome is a composite of poor neonatal outcome including:<br /><br><br /><br>Neonatal metabolic acidosis (umbilical artery pH < 7.05 + base deficit (full<br /><br>blood) > 12 mmol/l);<br /><br>Severe neonatal acidosis ( umbilical artery pH < 7.00);<br /><br>Five minute Apgar score < 7;<br /><br>Neonatal death within 28 days;<br /><br>Evidence of hypoxic ischemic encephalopathy (Sarnat stage 2 or 3).<br /><br><br /><br>Maternal secondary outcome variables include mode of delivery and blood loss<br /><br>during delivery.<br /><br><br /><br>Also cost and effects are measured as well as patient reported outcomes. See<br /><br>protocol page 22. </p><br>