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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Pregnancy Related

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