Condition category
Pregnancy and Childbirth
Date applied
23/09/2007
Date assigned
02/10/2007
Last edited
03/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Regional City Council Research and Development Foundations (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medexa AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lomma (Sweden)

Alternative name(s)

Funding Body Type

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

  1. 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.

Additional files

Editorial Notes