3,321
Participants
Start Date
November 2, 2021
Primary Completion Date
June 8, 2022
Study Completion Date
May 24, 2023
SGB PCR
"This is a multi-center, randomized cluster and crossover study, and is open-label. The cluster is defined by the hospital center. Each center will therefore experiment with both strategies and the hospital centers will be randomized according to two arms:~* Arm n°1 : 1st period with SGB culture strategy and 2nd period with SGB PCR strategy.~* Arm n°2 : 1st period with SGB PCR Strategy and 2nd period with SGB culture Strategy Each inclusion period will last 6 weeks, with a 1-month wash-in period before each of the two inclusion periods of the study (training of the teams in intrapartum PCR detection). A wash-out period is not necessary in this study because the PCR machine will be removed from the centers when switching to the GBS culture strategy.~During these two periods, all patients meeting the inclusion and non-inclusion criteria will be included in the study after presentation of the study and oral consent."
SGB culture
"This is a multi-center, randomized cluster and crossover study, and is open-label. The cluster is defined by the hospital center. Each center will therefore experiment with both strategies and the hospital centers will be randomized according to two arms:~* Arm n°1 : 1st period with SGB culture strategy and 2nd period with SGB PCR strategy.~* Arm n°2 : 1st period with SGB PCR Strategy and 2nd period with SGB culture Strategy Each inclusion period will last 6 weeks, with a 1-month wash-in period before each of the two inclusion periods of the study (training of the teams in intrapartum PCR detection). A wash-out period is not necessary in this study because the PCR machine will be removed from the centers when switching to the GBS culture strategy.~During these two periods, all patients meeting the inclusion and non-inclusion criteria will be included in the study after presentation of the study and oral consent."
Sentilhes, Bordeaux
Lassel, Rennes
Multon, Nantes
Gillard, Angers
Morel, Nancy
Lecointre, Strasbourg
Roumieu, Lyon
Kayem, Paris
Anselem, Paris
Schmitz, Paris
Houllier, Le Kremlin-Bicêtre
Direction Générale de l'Offre de Soins
OTHER_GOV
Nantes University Hospital
OTHER