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Cardiotocography combined with ST analysis versus cardiotocography combined with fetal blood sampling in deliveries with abnormal CTG: a randomized trial

  • Maternal-Fetal Medicine
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

The aim was to investigate if intrapartum monitoring with cardiotocography (CTG) in combination with ST analysis (STAN) results in an improved perinatal outcome.

Methods

We performed a two-center randomized trial. 1013 women with term fetuses in cephalic presentation entered the trial. If a CTG showed intermediate or pathological abnormalities, they were offered fetal blood sampling (FBS) and inclusion if the pH value was above 7.25. They were randomized to either CTG + FBS or CTG + STAN. The primary outcome was neonatal metabolic acidosis, defined as umbilical cord arterial blood pH below 7.05, and base excess equal to or below −10. The secondary outcomes included operative vaginal delivery for fetal distress.

Results

The rate of metabolic acidosis was 0.8% in the CTG + FBS group and 1.5% in women in the CTG + STAN (P = 0.338). More women in the CTG + STAN group delivered by operative vaginal delivery (25.6% vs 33.5%, P = 0.006). Significantly fewer women in the CTG + STAN group had three to five (28.8% vs 11.0%, P =  < 0.001) and six to ten fetal blood samples taken (3.4% vs 0.4%, P =  < 0.001).

Conclusion

CTG + STAN did not reduce the incidence of neonatal metabolic acidosis compared to CTG + FBS. CTG + STAN was, however, associated with an increased risk of operative vaginal delivery and a reduced use of FBS. If STAN is used for fetal surveillance, we recommend that it is combined with other methods, such as FBS, for confirmation of the need for operative delivery.

Clinicaltrials.gov ID: NCT01699646.

Date of registration: October 4, 2012 (retrospectively registered).

https://clinicaltrials.gov/ct2/show/NCT01699646?id=NCT01699646&draw=2&rank=1

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Abbreviations

AS-1:

Apgar score 1 min after birth

AS-5:

Apgar score 5 min after birth

CTG:

Cardiotocography

ECG:

Electrocardiogram

FBS:

Fetal blood sampling

aFBS:

Additional fetal blood sampling; this term is used for every FBS taken after the FBS upon inclusion

NICU:

Neonatal intensive care unit

RCT:

Randomized controlled trial

RR:

Relative risk

STAN:

ST-segment analysis

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Funding

The project was allocated 2.5 million DKK in funding for the project from the Elsass Foundation, a private foundation with no financial interest in the project equipment, appliances or monitors. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. https://www.elsassfonden.dk/.

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Zealand University Hospital, Holbæk, Denmark

    Simon Foged Victor

  2. Department of Gynecology and Obstetrics, Copenhagen University Hospital, Amager and Hvidovre Hospital, Copenhagen, Denmark

    Diana Bøttcher Brøndum Bach, Carsten Nickelsen, Tom Weber, Niels Jørgen Secher & Lone Krebs

  3. Department of Pediatrics, Copenhagen University Hospital, Amager and Hvidovre Hospital, Copenhagen, Denmark

    Anna Carolina Hvelplund

  4. Department of Gynecology and Obstetrics, Zealand University Hospital, Roskilde, Denmark

    Jens Lyndrup, Charlotte Wilken-Jensen & Lise Jul Scharff

  5. Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark

    Lone Krebs

Authors
  1. Simon Foged Victor
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Contributions

All authors fulfill the Vancouver criteria for authorship and have contributed as follows: SFV: manuscript writing, manuscript editing and data analysis. DBBB: protocol and project development, data collection and management, data analysis, manuscript editing. ACH: data collection and manuscript editing. CN: protocol and project development, manuscript editing. JL: data collection and manuscript editing. CW-J: data collection. LJS: data collection. TW: protocol and project development, data collection and manuscript editing. NJS: protocol and project development. LK: data analysis and manuscript editing.

Corresponding author

Correspondence to Simon Foged Victor.

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Competing interests

All authors have declared to have no conflicts of interests.

Ethics approval

Information regarding the participants was protected in accordance with the law of treatment of personal information and the law of patient’s legal position. The study was approved by the local science ethics committee under the journal number: (KF) 01 260 768. Good Publication Practice 3 (GPP3) guidelines were followed.

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Informed consent was obtained from all individual participants included in the study.

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Deceased: Carsten Nickelsen and Niels Jørgen Secher.

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Victor, S.F., Bach, D.B.B., Hvelplund, A.C. et al. Cardiotocography combined with ST analysis versus cardiotocography combined with fetal blood sampling in deliveries with abnormal CTG: a randomized trial. Arch Gynecol Obstet 307, 1771–1780 (2023). https://doi.org/10.1007/s00404-022-06649-3

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