CompletedNot Applicable

The Oslo Stan vs Lactate Observational Study

Norway694 participantsStarted 2018-09-01

Plain-language summary

The main aim of the study is to compare the clinical performance of two adjunctive methods to CTG in intrapartum fetal monitoring: FBS with measurement of scalp lactate and ST analysis of the fetal ECG.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Singleton pregnancy * Cephalic presentation * Gestational age ≥36+0 weeks at delivery * Presence of antpartum or intrapartum risk factors for fetal hypoxia according to Norwegian guidelines and therefore indication for electronic fetal monitoring with scalp electrode . Exclusion Criteria: * Multiple pregnancies * Breech presentation * Gestational age \< 36+0 weeks * Contraindications for placement of a scalp electrode (HIV or HBV or HCV pos)

What they're measuring

Is fetal hypoxia (defined as arterial umbilical cord pH < 7,1 postpartum) superiorly identified by fetal scalp blood sampling (lactate) or ST analysis of fetal ECG

Timeframe: 2019-2022

Is cord blood acidosis, measured as pH in the umbilical artery postpartum affected by the "Decision-to-delivery interval" measured in minutes from Lactate warning until delivery.

Timeframe: 2019-2022

Trial details

NCT IDNCT04779294

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-31

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