Carriage of Beta Haemolytic Streptococci During Pregnancy

March 20, 2024 updated by: Turku University Hospital
This is a prospective clinical study that aims to investigate asymptomatic carriage of beta haemolytic streptococci (especially group A streptococci, GAS and group B streptococci, GBS) during pregnancy. Association of asymptomatic carriage to possible complications of the mother or the newborn as well as the transmission between spouses will be evaluated. Maternal microbiota during labour will also be studied.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1040

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kirsi Gröndahl-Yli-Hannuksela
  • Phone Number: +358294504548
  • Email: kagron@utu.fi

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women attending ultrasound scan are asked to participate in the study. Partners of the pregnant women are asked to participate as well.

Description

Inclusion Criteria:

  • pregnant women
  • partner of the pregnant women
  • over/equal 18 years of age
  • willing to participate the study

Exclusion Criteria:

  • multiple pregnancy
  • age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pregnant women
Microbiological samples are collected from the pregnant women in the mid-pregnancy and during the delivery. Patient records of these women and newborns are investigated for any infections or complications during and after the delivery.
Partners
Partners of the pregnant women will be studied to understand the household transmission of studied bacteria and possible risk factors for carriage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carriage of beta haemolytic streptococci
Time Frame: up to 30 weeks
Throat and vaginal carriage of beta haemolytic streptococci (especially GAS and GBS) during pregnancy. Transmission and longitude of the carriage will be evaluated as well.
up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy or delivery related infections/complications
Time Frame: up to12 weeks
Patient records of the pregnant women will be surveyed for any complications/infections until 12 week after delivery. Data will be analysed together with the microbiological findings from the women.
up to12 weeks
Infections/complications of newborn
Time Frame: 12 weeks after birth
Patient records are surveyed to search for any infections/complications of the newborn until 12 weeks of age. Data will be analysed together with the findings from their mother.
12 weeks after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 67/1801/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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