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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

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 - Scalp trial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37995
Enrollment
230
Registered
2012-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

fetal asphyxia fetal compromise fetal distress

Interventions

The intervention (standard practice in teaching hospitals) is FBS in case of an abnormal CTG (FIGO/STAN criteria) with further action based on its results according to the following guidelines: pH

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Major congenital anomalies

Design outcomes

Primary

MeasureTime frame
The primary outcome is the CS rate for all indications.—

Secondary

MeasureTime frame
Secondary outcome is a composite of poor neonatal outcome including: Neonatal metabolic acidosis (umbilical artery pH 12 mmol/l); Severe neonatal acidosis ( umbilical artery pH—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)