NCT05365711

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,040

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

April 26, 2022

Last Update Submit

March 20, 2024

Conditions

Pregnancy Related

Keywords

pregnancygroup a streptococcigroup b streptococcicarriagemicrobiotaStreptococcus pyogenesStreptococcus agalactiae

Outcome Measures

Primary Outcomes (1)

  • Carriage of beta haemolytic streptococci

    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 Outcomes (2)

  • Pregnancy or delivery related infections/complications

    up to12 weeks

  • Infections/complications of newborn

    12 weeks after birth

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPregnant women and their partners
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • multiple pregnancy
  • age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 9, 2022

Study Start

June 1, 2022

Primary Completion

April 1, 2024

Study Completion

December 1, 2025

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

FI(1)