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
Secondary identifying numbers N/A
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

Study designRandomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Scientific title
Study objectivesThe 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) studiedIntrapartum fetal monitoring
InterventionOf 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 typeOther
Primary outcome measurePrevalence of metabolic acidemia or pH less than 7.00
Secondary outcome measuresSecondary 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 study start date13/12/2002
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsInitial target number: 3,000 (3,007 recruited)
Key inclusion criteria1. 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 criteria1. Gestational age <34 weeks
2. Breech or multiple pregnancies
Date of first enrolment13/12/2002
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Sweden

Study participating centre

Department of Obstetrics and Gynaecology
Stockholm
171 76
Sweden

Sponsor information

Karolinska University Hospital (c/o Lennart Nordström)
University/education

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

Phone +46 8 517 70888
Email lennart.nordstrom@karolinska.se
ROR logo "ROR" https://ror.org/00m8d6786

Funders

Funder type

Research organisation

Signhild Engqvists Research Foundation (Signhild Engqvists Stiftelse) (Sweden)

No information available

The Stockholm Public Labour Ward Department Memorial Research Foundation (Allmänna BB's minnesfond) (Sweden)

No information available

The Regional City Council Research and Development Foundations (Sweden)

No information available

The Health and Medical Committee of the Region Västra Götland (Sweden)

No information available

Medexa AB (Sweden)

No information available

Lomma (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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