Contact information
Type
Scientific
Primary contact
Dr Lennart Nordstrom
ORCID ID
Contact details
Department of Obstetrics and Gynaecology
Karolinska University Hospital
Stockholm
171 76
Sweden
lennart.nordstrom@karolinska.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Karolinska Institute Regional Ethics Committee. Approved in 2002 (ref: 109/02).
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Prevalence of metabolic acidemia or pH less than 7.00
Secondary outcome measures
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)
Overall trial start date
13/12/2002
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Initial target number: 3,000 (3,007 recruited)
Participant exclusion criteria
1. Gestational age <34 weeks
2. Breech or multiple pregnancies
Recruitment start date
13/12/2002
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Obstetrics and Gynaecology
Stockholm
171 76
Sweden
Sponsor information
Organisation
Karolinska University Hospital (c/o Lennart Nordström)
Sponsor details
Department of Obstetrics and Gynaecology
Karolinska University Hospital
Stockholm
171 76
Sweden
+46 8 517 70888
lennart.nordstrom@karolinska.se
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Signhild Engqvists Research Foundation (Signhild Engqvists Stiftelse) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Stockholm Public Labour Ward Department Memorial Research Foundation (Allmänna BB's minnesfond) (Sweden)
Alternative name(s)
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Funding Body Subtype
Location
Funder name
The Regional City Council Research and Development Foundations (Sweden)
Alternative name(s)
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Location
Funder name
The Health and Medical Committee of the Region Västra Götland (Sweden)
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Location
Funder name
Medexa AB (Sweden)
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Funder name
Lomma (Sweden)
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Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18503103
Publication citations
-
Results
Wiberg-Itzel E, Lipponer C, Norman M, Herbst A, Prebensen D, Hansson A, Bryngelsson AL, Christoffersson M, Sennström M, Wennerholm UB, Nordström L, Determination of pH or lactate in fetal scalp blood in management of intrapartum fetal distress: randomised controlled multicentre trial., BMJ, 2008, 336, 7656, 1284-1287, doi: 10.1136/bmj.39553.406991.25.