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Fetal scalp blood pH or lactate determination in the management of intrapartum fetal distress: A randomised controlled multi-centre trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN01606064
Enrollment
Unknown
Registered
2007-10-02
Start date
2002-12-13
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Intrapartum fetal monitoring Pregnancy and Childbirth Intrapartum fetal monitoring

Interventions

Of the 3,007 participants recruited and randomised, 15 participants were excluded due to multiple pregnancies or gestational age <34 weeks. Final analysis was carried out on 2,992 cases, 1,496 in each

Sponsors

Karolinska University Hospital (c/o Lennart Nordström)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women in labour with a singleton pregnancy 2. Gestational age >34 weeks 3. Cephalic presentation 4. Clinical situation where a fetal scalp blood sampling was indicated 5. Those who had given consent

Exclusion criteria

Exclusion criteria: 1. Gestational age <34 weeks 2. Breech or multiple pregnancies

Design outcomes

Primary

MeasureTime frame
Prevalence of metabolic acidemia or pH less than 7.00

Secondary

MeasureTime frame
Secondary outcome measures: 1. Protocol violation (mainly due to failed sampling or analysis) 2. Rate of instrumental deliveries 3. Rate of cesarean section 4. Apgar score less than 7 at 5 min 5. Admissions to neonatal intensive care unit Tertiary outcome measures: 1. Prevalence of pH less than 7.10 2. Rate of intervention due to fetal distress 3. Rate of Hypoxic Ischemic Encephalopathy (HIE)

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026