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  3. Determination of pH or lactate in fetal scalp blood in management of intrapartum fetal distress: randomised controlled multicentre trial
Research

Determination of pH or lactate in fetal scalp blood in management of intrapartum fetal distress: randomised controlled multicentre trial

BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39553.406991.25 (Published 05 June 2008) Cite this as: BMJ 2008;336:1284
  1. E Wiberg-Itzel, consultant obstetrician1,
  2. C Lipponer, consultant obstetrician2,
  3. M Norman, consultant obstetrician3,
  4. A Herbst, consultant obstetrician4,
  5. D Prebensen, consultant obstetrician5,
  6. A Hansson, consultant obstetrician6,
  7. A-L Bryngelsson, consultant obstetrician7,
  8. M Christoffersson, consultant obstetrician8,
  9. M Sennström, senior registrar9,
  10. U-B Wennerholm, consultant obstetrician2,
  11. L Nordström, consultant obstetrician, head of department9
  1. 1Departments of Obstetrics and Gynaecology Söder Hospital, Stockholm
  2. 2Sahlgrenska University Hospital, East, Gothenburg
  3. 3Danderyd Hospital, Stockholm
  4. 4Lund University Hospital, Lund
  5. 5Trollhättan Central Hospital, Trollhättan
  6. 6Karlstad Central Hospital, Karlstad
  7. 7Örebro University Hospital, Örebro
  8. 8Kalmar County Hospital, Kalmar
  9. 9Karolinska University Hospital, Karolinska Institute, 171 76 Stockholm, Sweden
  1. Correspondence to: L Nordström lennart.nordstrom{at}karolinska.se
  • Accepted 31 March 2008

Abstract

Objective To examine the effectiveness of pH analysis of fetal scalp blood compared with lactate analysis in identifying hypoxia in labour to prevent acidaemia at birth.

Design Randomised controlled multicentre trial.

Setting Labour wards.

Participants Women with a singleton pregnancy, cephalic presentation, gestational age ≥34 weeks, and clinical indication for fetal scalp blood sampling.

Interventions Standard pH analysis (n=1496) or lactate analysis (n=1496) with an electrochemical microvolume (5 μl) test strip device. The cut-off levels for intervention were pH <7.21 and lactate >4.8 mmol/l, respectively.

Main outcome measure Metabolic acidaemia (pH <7.05 and base deficit >12 mmol/l) or pH <7.00 in cord artery blood.

Results Metabolic acidaemia occurred in 3.2% in the lactate group and in 3.6% in the pH group (relative risk 0.91, 95% confidence interval 0.61 to 1.36). pH <7.00 occurred in 1.5% in the lactate group and in 1.8% in the pH group (0.84, 0.47 to 1.50). There was no significant difference in Apgar scores <7 at 5 minutes (1.15, 0.76 to 1.75) or operative deliveries for fetal distress (1.02, 0.93 to 1.11).

Conclusion There were no significant differences in rate of acidaemia at birth after use of lactate analysis or pH analysis of fetal scalp blood samples to determine hypoxia during labour.

Trial registration ISRCT No 1606064.

Footnotes

  • We thank all the women who took part in the trial and the obstetricians and midwives who recruited patients and managed their labours. The following hospitals took part: Danderyd, Kalmar, Karlstad, Karolinska, Lund, Söder Hospital, Trollhättan, Örebro, Gothenburg, Linköping. We also thank Hans Pettersson, Department of Biostatistics, Karolinska Institute at Söder Hospital, Stockholm, Sweden, for excellent statistical advice. The independent steering committee comprised Sven Cnattingius, Bengt Persson, Magnus Westgren, Karolinska Institutet, Stockholm, Sweden.

  • Contributors: LN had the original idea for the study, launched the network of collaborators, contributed to study design, the creation of a web based randomisation and reporting database, analysis and interpretation of data, and writing the paper and is guarantor. EW-I contributed to the study design, implemented the guidelines to all departments, contributed to analysis and interpretation of the data and writing the paper. CL, MN, AHe, DP, AHa, A-LB, MC, MS, and U-BW contributed to the study design, analysis and interpretation of data, and writing the paper. All authors have seen and approved the final version.

  • Funding: Signhild Engqvists Stiftelse, Allmänna BB’s Minnesfond, the regional city council research and development foundations, the health and medical committee of the region Västra Götaland, and Medexa, Lomma, Sweden.

  • Competing interests: EW-I and LN are shareholders in Obstecare, a company dealing with development of IT based decision support for labour dystocia. No product is yet on the market.

  • Ethical approval: Karolinska Institutet, Stockholm, Sweden (file record 109/02).

  • Provenance and peer review: Not commissioned; externally peer reviewed.

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