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

ISRCTN	ISRCTN01606064
DOI	https://doi.org/10.1186/ISRCTN01606064
Protocol serial number	N/A
Sponsor	Karolinska University Hospital (c/o Lennart Nordström)
Funders	Signhild Engqvists Research Foundation (Signhild Engqvists Stiftelse) (Sweden), The Stockholm Public Labour Ward Department Memorial Research Foundation (Allmänna BB's minnesfond) (Sweden), The Regional City Council Research and Development Foundations (Sweden), The Health and Medical Committee of the Region Västra Götland (Sweden), Medexa AB (Sweden), Lomma (Sweden)

Submission date: 23/09/2007
Registration date: 02/10/2007
Last edited: 03/06/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lennart Nordstrom
Scientific

Department of Obstetrics and Gynaecology
Karolinska University Hospital
Stockholm
171 76
Sweden

Email	lennart.nordstrom@karolinska.se

Study information

Primary study design	Interventional
Study design	Randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The analysis of fetal scalp blood pH has been the gold standard in intrapartum management of suspected or known pathological fetal heart rate traces. However, this method has a reported sampling failure rate of 11-21%. Lactate analysis has simplified sampling, mainly due to the minimal amount of blood needed. Lactate is also an end product after anaerobic metabolism, which is of interest to analysis. Our hypothesis is that analysis of lactate in fetal scalp blood is at least as good as pH determination in the prevention of severe acidemia at birth with less sampling failure.
Ethics approval(s)	Karolinska Institute Regional Ethics Committee. Approved in 2002 (ref: 109/02).
Health condition(s) or problem(s) studied	Intrapartum fetal monitoring
Intervention	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 arm. Oral and written information about the trial was given to possible participants at the antenatal clinic in late pregnancy. Oral consent was obtained from the participants at antenatal follow up visits or in early labour. Randomisation of participants to the two arms was performed at the time a clinician decided to perform a fetal scalp blood analysis. Interventions: Fetal scalp blood analysis for pH or lactate as basis for decision to intervene (cesarean section or instrumental delivery) or not.
Intervention type	Other
Primary outcome measure(s)	Prevalence of metabolic acidemia or pH less than 7.00
Key secondary outcome measure(s)	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)
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key 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
Key exclusion criteria	1. Gestational age <34 weeks 2. Breech or multiple pregnancies
Date of first enrolment	13/12/2002
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Obstetrics and Gynaecology

Stockholm
171 76
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	07/06/2008		Yes	No