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
Scientific
Department of Obstetrics and Gynaecology
Karolinska University Hospital
Stockholm
171 76
Sweden
| lennart.nordstrom@karolinska.se |
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| 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 | 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 study start date | 13/12/2002 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Initial target number: 3,000 (3,007 recruited) |
| 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
171 76
Sweden
Sponsor information
Karolinska University Hospital (c/o Lennart Nordström)
University/education
University/education
Department of Obstetrics and Gynaecology
Karolinska University Hospital
Stockholm
171 76
Sweden
| Phone | +46 8 517 70888 |
|---|---|
| lennart.nordstrom@karolinska.se | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
