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

NCT05005169 | Completed

• 1 other identifier: RC20_0069
• Study Type: interventional
• Target: 3,321
• Locations: 1 country
• Sites: 11

Brief Summary

Early-onset neonatal infection (EONI), occur within 7 days of birth. They are most often due to Streptococcus B (GBS) and are associated with heavy and costly morbidity and mortality. The strategy combining antenatal detection (PV9) of GBS colonization and intrapartum antibiotic therapy has led to a spectacular decrease in the number of GBS EONI's that have become rare (0.3/1000 births). Current detection is based on the culture of a vaginal swab taken between 35 and 38 SA. Because the positive predictive value of PV9 compared to a culture on the day of delivery is 60%, two problems persist: i) 20% of women and newborns are sometimes unnecessarily exposed to antibiotics with known short-term and long-term harmful effects; ii) more than half of newborns developing EONI are born to mothers with negative PV9. There is a risk of not treating intrapartum colonization when PV9 is negative, and overtreating an uncolonized PV9-positive woman at the time of delivery. These inappropriate antibiotic therapies generate additional maternal-fetal care, examinations, treatments and hospitalizations with significant costs. Today, a feasible, rapid, sensitive (90-95%) and specific (95-98%) PCR test (Xpert GBS, CEPHEID) can be used to detect women colonized with GBS at the beginning of labor. A recent study (submitted for publication) including 782 women with risk factors for infection (intrapartum fever or prolonged rupture of membranes) who were subjected to PV9 and intrapartum PCR (IP PCR), identified 19% potential reclassification of GBS status, with a potential saving of 6% intrapartum antibiotic. We postulate that the replacement of PV9 by the generalized use of GBS intrapartum detection would optimize the indications for intrapartum antiobiotherapy, avoiding (i) unnecessary and deleterious care consumption in the absence of intrapartum GBS colonization, and (ii) avoidable EONIs occurring in the absence of intrapartum antiobiotherapy when GBS colonization has not been diagnosed. We propose to conduct a cost-consequence study because the criteria for clinically relevant judgments do not allow for cost-effectiveness or cost-utility analysis. Indeed, the intrapartum PCR strategy has consequences for both mother and child and these consequences cannot be aggregated. Thus, cost-consequence analysis based on criteria validated by clinicians and the literature seemed to us to be the most pragmatic approach and the most likely to help public decision making. The objective of this work is therefore to carry out a cost-consequence analysis comparing the intrapartum antibiotic prophylaxis strategy based on intrapartum GBS colonization screening by PCR, with the current strategy based on antenatal screening by culture between 35 and 38 SA.

Conditions

Streptococcus Agalactiae

Keywords

Health economics, streptococcus B, screening, PCR

Outcome Measures

Primary Outcomes (1)

• Comparison of total cost of antenatal culture versus intrapartum PCR screening strategy

  Cost-consequence analysis: \- Comparison of the total cost (collective perspective) of the screening strategy (expressed in euros) by antenatal culture versus intrapartum PCR from PV to 30 days postpartum.

  Day 30

Secondary Outcomes (6)

• Neonatal morbidity-mortality criterion for NPI composite combining over the first 6 days of life

  Day 6

• Criteria for maternal-fetal exposure to antibiotics

  Day 30

• Maternal morbidity and mortality criteria at 30 days after delivery

  Day 30

• Proportion of appropriate intrapartum TBAs in the CRP arm compared to what would have been indicated using current recommendations

  Day 0

• Feasibility criteria for the intrapartum GBS PCR screening strategy

  Day 0

Study Arms (2)

intrapartum streptococcal B detection by PCR

EXPERIMENTAL

The automatons will be installed by the laboratory in the delivery rooms and used delocalized by the obstetrical teams. Verification and validation of results will be ensured by the microbiology laboratory team, according to the recommendations and procedures already in use for off-site biology.

Diagnostic Test: SGB PCR

intrapartum streptococcal B detection by "SGB culture" strategy

ACTIVE COMPARATOR

Diagnostic Test: SGB culture

Interventions

SGB PCR DIAGNOSTIC_TEST

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.

Also known as: Test Xpert® SGB and GeneXpert® Systems / GeneXpert® IV System (GX-4) - CEPHEID

intrapartum streptococcal B detection by PCR

SGB culture DIAGNOSTIC_TEST

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.

intrapartum streptococcal B detection by "SGB culture" strategy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women of childbearing age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the delivery room from 35SA upwards
• Planned vaginal delivery
• Patients who agreed to participate in the study and gave oral consent
• Patient affiliated to a social security system

You may not qualify if:

• Complete dilatation (imminent delivery)
• Scheduled caesarean
• Term \< 35 SA
• Death in utero
• Medical termination of pregnancy
• Does not speak French
• Opposition to participating in the study

Sponsors & Collaborators

• Nantes University Hospital: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (11)

Multon

Nantes, Saint Herblain, 44819, France

Location

Gillard

Angers, 49933, France

Location

Sentilhes

Bordeaux, 33000, France

Location

Houllier

Le Kremlin-Bicêtre, 94275, France

Location

Roumieu

Lyon, 69002, France

Location

Morel

Nancy, 54000, France

Location

Kayem

Paris, 75012, France

Location

Anselem

Paris, 75014, France

Location

Schmitz

Paris, 75019, France

Location

Lassel

Rennes, 35203, France

Location

Lecointre

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Pathologic Complete Response

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christèle Gras-Le Guen, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: August 13, 2021
• Study Start: November 2, 2021
• Primary Completion: June 8, 2022
• Study Completion: May 24, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)