Skip to main content
OpenTrials
Completed

NCT Number: NCT01719510

Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis

The main objective of this study : Demonstrate that GBS (group B streptococci) "ST-17" colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS non-ST-17.

Secondary objectives:Determine:

* The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant women. * The frequency of colonization of neonates by GBS ST-17 at birth. * The preferential site of colonization in the mother (rectum, vagina, breast milk). * The kinetics of colonization after birth in the newborn. * The sensitivity and specificity of different GBS detection methods (conventional phenotypic versus molecular) in the different types of samples from the mother and the newborn.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Louis Mourier Hospital, Colombes, France

Loading trial locations.

About this study

Women tested positive for GBS during systematic vaginal screening at 35-37 weeks, will be proposed to participate to the study and will be included after reading the information letter and signature the consent form.

INCLUSION (D0 at time of delivery)

In the labor ward, two women's groups 1 and 2:

Group 1 = Women tested positive for GBS pre-selected and included in the protocol (see pre-inclusion) Group 2 = Women without antenatal vaginal screening and at risk of neonatal infection.

For both groups, at time of delivery:

At the beginning of the labour performed vaginal swabs (PV0):

  • one swab for GBS detection by real-time PCR using the Cepheid technique conducted in the labor ward by the midwife.
  • the second swab for GBS detection by conventional bacteriological techniques and sent to the bacteriology laboratory.

For all women included (Group 1 and Group 2 women with a positive GBS vaginal sample) will be achieved in the delivery room:

  • To the mother: A blood sample of 5 ml at the time of the implementation of the IV line.
  • A sampling of umbilical cord blood. Newborns of mothers included (group 1 and 2) will have a search for GBS (standard culture) in the stools and the pharynx prior to return home. Samples will be sent to the bacteriology laboratory and analyzed by classical bacteriological method (culture) and / or real-time PCR.

For mothers, the collection of 3-5 ml of milk when breastfeeding.

Monitoring schedule:

Day 21 and day 60 post delivery:

the following samples for search of GBS for will be performed to gather the primary endpoint:

For the mother:

  • Vaginal sample.
  • Collection of 3-5 ml of breast milk when breastfeeding

For the newborn:

  • Sample collection of feces
  • Swab of buccal cavity

Processing bacteriological samples:

All samples will be subjected to bacteriological analysis and DNA extraction for detection of GBS. GBS isolated will be identified and stored at - 80 ° C in a declared biological collection. DNA extracts will also stored at -20 ° C in a declared biological collection. All samples for microbiological analysis will be stored at - 80 ° C.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient having a positive vaginal swab for GBS at the end of pregnancy (PCR +).
  • Patient aged over 18 years
  • Patient who received information and agreeing to sign informed consent
  • Patient affiliated or beneficiary of an insurance

Exclusion criteria

  • Patient does not speak and does not understand French

Treatment and study plan

Samples

Other

At time of delivery we will performed vaginal swabs in two groups: women tested positive for GBS at 35-37 weeks and women with risk of neonatal infection.

For both groups:

  • one swab for GBS detection by real-time PCR
  • the second swab for GBS detection by conventional bacteriological techniques and sent to the bacteriology laboratory.

For all women included will be achieved in the delivery room:

  • To the mother: A blood sample of 5 ml at the time of the implementation of the IV line.
  • A sampling of umbilical cord blood.

Newborns of mothers included (group 1 and 2) will have a search for GBS (standard culture) in the stools and the pharynx prior to return home.

For mothers, the collection of 3-5 ml of milk when breastfeeding.

Primary outcomes

  1. Detection of the hyper-virulent ST17 clone of Group B Strep

    Time frame: at 60 days post delivery

    Detection of the hyper-virulent ST17 clone of Group B Strep (GBS) in the prevention of neonatal GBS meningitis. The main objective is to demonstrate that the hypervirulent ST17 GBS clone colonizing the mother and postpartum acquired colonizes and persists at 60 days post delivery in the gut of new born significantly more than non-ST17 GBS strains.

Secondary outcomes

  1. Digestive colonization

    Time frame: at day 21

    Digestive colonization of ST17 clone of Group B Strep in the newborns

  2. Milk colonization

    Time frame: at day 21 and day 60

    Colonization of milk by ST17 clone of Group B Strep

  3. Vaginal colonization

    Time frame: at day 21 and day 60

    Vaginal colonization by ST17 clone of Group B Strep

  4. Late neonatal infections

    Time frame: between 3 weeks and 60 days

    Late neonatal infections will be observed between 3 weeks and 60 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B

Acronym: Col-Strepto B

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 1, 2012
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.