Comparison of effect of CTG + STan with CTG alone on emergency Cesarean section rate: STan Australian Randomized controlled Trial (START).

CTG Cesarean section RCT ST analysis STan cardiotocography fetal ECG fetal electrocardiography intrapartum fetal monitoring randomized controlled trial

Journal

Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology
ISSN: 1469-0705
Titre abrégé: Ultrasound Obstet Gynecol
Pays: England
ID NLM: 9108340

Informations de publication

Date de publication:
Oct 2023
Historique:
revised: 11 05 2023
received: 11 01 2023
accepted: 24 05 2023
medline: 23 10 2023
pubmed: 8 6 2023
entrez: 8 6 2023
Statut: ppublish

Résumé

To investigate whether use of ST analysis of the fetal electrocardiogram (STan) as an adjunct to continuous cardiotocography (CTG) reduces the rate of emergency Cesarean section (EmCS) compared with CTG alone. This was a randomized controlled trial of patients with a singleton fetus in cephalic presentation at ≥ 36 weeks' gestation, requiring continuous electronic fetal monitoring during labor at a tertiary maternity hospital in Adelaide, Australia, between January 2018 and July 2021. Participants were randomized to undergo CTG + STan or CTG alone. The calculated sample size was 1818 participants. The primary outcome was EmCS. Secondary outcomes included metabolic acidosis, a composite adverse perinatal outcome, and other maternal and neonatal morbidity and safety outcomes. The present study enrolled 970 women, of whom 967 were included in the primary analysis. EmCS occurred in 107/482 (22.2%) deliveries in the CTG + STan arm and in 107/485 (22.1%) in the CTG arm (adjusted relative risk, 1.02 (95% CI, 0.81-1.27); P = 0.89). There was no difference in the rate of adverse maternal or neonatal outcomes between arms. The addition of STan as an adjunct to continuous CTG did not reduce the EmCS rate. The smaller-than-anticipated sample size meant that this study was underpowered to detect absolute differences of ≤ 5% and, therefore, this negative finding could be due to a Type-2 error. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Identifiants

pubmed: 37289946
doi: 10.1002/uog.26279
doi:

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

462-470

Subventions

Organisme : National Health and Medical Research Council
ID : 1129648

Informations de copyright

© 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

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Auteurs

S Kuah (S)

Women's and Children's Hospital, North Adelaide, SA, Australia.

B Simpson (B)

Women's and Children's Hospital, North Adelaide, SA, Australia.
Women's and Children's Health, Adelaide Medical School, University of Adelaide, North Adelaide, SA, Australia.

A Salter (A)

School of Public Health, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.

G Matthews (G)

Women's and Children's Hospital, North Adelaide, SA, Australia.

J Louise (J)

Women's and Children's Hospital, Faculty of Health and Medical Sciences, University of Adelaide, North Adelaide, SA, Australia.

J Bednarz (J)

School of Public Health, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.
South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Adelaide, SA, Australia.

E Chandraharan (E)

Global Academy of Medical Education and Training Ltd, London, UK.

I Symonds (I)

Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.

A McPhee (A)

South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Adelaide, SA, Australia.

B W Mol (BW)

Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia.
Aberdeen Centre for Women's Health Research, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.

D Turnbull (D)

School of Psychology, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.

C Wilkinson (C)

Women's and Children's Hospital, North Adelaide, SA, Australia.

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