Intrapartum group B streptococcus (GBS) detection by intrapartum PCR versus antenatal culture at 35-38 weeks of gestation: Justification for a crossover, cluster randomized controlled trial, and protocol summary - 28/01/26

Doi : 10.1016/j.arcped.2025.11.003

Marine Godfroy ^a, Agnès Caille ^b,^c, Isabelle Durand Zaleski ^d, Pauline Scherdel ^e, Marion Boivin ^e, Ingrid Benard ^f, Anne Chauvire-Drouard ^e, Valery-Pierre Riche ^f, Vincent Dochez ^a,^b,^c,^d,^e,^f,^g, Norbert Winer ^a,^b,^c,^d,^e,^f,^g, Christèle Gras Le Guen ^e,^f,^g,^h,^⁎

^a Gynecologic and Obstetric Department, University Hospital of Angers, France

^b Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France

^c INSERM CIC1415, CHRU de Tours, Tours, France

^d University Paris Est, AP-HP Health Economics Research Unit, Hôtel-Dieu Hospital, INSERM UMR 1153 CRESS, Paris, France

^e Nantes Université, CHU Nantes, INSERM, CIC 1413, F-44000 Nantes, France

^f University of Nantes, Research and Innovation Direction, CHU Nantes, F-44000 Nantes, France

^g Gynecologic and Obstetric department, University Hospital of Nantes, France

^h Pediatric department, University hospital of Nantes, CHU Nantes, F-44000 Nantes, France

^⁎ Corresponding author at. Pediatrics department, 38 Bd Jean Monnet, 44000 Nantes. Pediatrics department 38 Bd Jean Monnet Nantes. 44000

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Wednesday 28 January 2026

Abstract

The incidence of neonatal group B streptococcus (GBS) related to early onset sepsis (EOS) has decreased dramatically with antenatal culture screening and intrapartum antibiotic prophylaxis (IAP) implementation during the 1990s. However, while 30 % of women are currently exposed to intrapartum antibiotics, 52 to 82 % of newborns with GBS-EOS were born to mothers with negative antenatal GBS culture screening who did not receive IAP, because of possible intermittent maternal GBS colonization. Intrapartum GBS screening by Polymerase Chain Reaction (PCR) has been suggested as a suitable tool to improve and replace the usual antenatal GBS culture screening between 35 and 38 weeks of amenorrhea for optimizing the IAP indications, but its cost is often cited as an obstacle. Using a cluster crossover randomized controlled trial, we aim i) to conduct a cost-consequence analysis of two screening strategies and ii) to compare newborn and maternal morbi-mortality related to GBS-EOS and antibiotic exposure rate according to an intrapartum screening strategy versus usual antenatal culture screening (DEPIST2P study).

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Keywords : GBS screening, Early-onset neonatal sepsis, Point of care PCR, Antibiotic optimization, Economic evaluation