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NCT05365711 Clinical Trial

Carriage of Beta Haemolytic Streptococci During Pregnancy

Pregnancy Related Clinical Trial

Official title:
Carriage of Beta Haemolytic Streptococci During Pregnancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05365711
Other study ID # 67/1801/2021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date December 2025

Study information
Verified date March 2024
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1040
Est. completion date December 2025
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (2)
Lead Sponsor Collaborator
Turku University Hospital University of Turku

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Pregnancy or delivery related infections/complications 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
Secondary Infections/complications of newborn 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
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