CCA of SGB PCR Versus SGB Culture at 35-38 SA in the Optimization of Intrapartum Antibiotic Prophylaxis

NACompletedINTERVENTIONAL
Enrollment

3,321

Participants

Timeline

Start Date

November 2, 2021

Primary Completion Date

June 8, 2022

Study Completion Date

May 24, 2023

Conditions
Streptococcus Agalactiae
Interventions
DIAGNOSTIC_TEST

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."

DIAGNOSTIC_TEST

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."

Trial Locations (11)

33000

Sentilhes, Bordeaux

35203

Lassel, Rennes

44819

Multon, Nantes

49933

Gillard, Angers

54000

Morel, Nancy

67098

Lecointre, Strasbourg

69002

Roumieu, Lyon

75012

Kayem, Paris

75014

Anselem, Paris

75019

Schmitz, Paris

94275

Houllier, Le Kremlin-Bicêtre

All Listed Sponsors
collaborator

Direction Générale de l'Offre de Soins

OTHER_GOV

lead

Nantes University Hospital

OTHER

NCT05005169 - CCA of SGB PCR Versus SGB Culture at 35-38 SA in the Optimization of Intrapartum Antibiotic Prophylaxis | Biotech Hunter | Biotech Hunter