Pregnancy RelatedNCT05365711
Carriage of Beta Haemolytic Streptococci During Pregnancy
An observational study of Pregnancy Related, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 1,040 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2022to Dec 2025
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- pregnant women
- partner of the pregnant women
- over/equal 18 years of age
- willing to participate the study
Who cannot join
- multiple pregnancy
- age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pregnancy Related
- Keywords
- pregnancy, group a streptococci, group b streptococci, carriage, microbiota, Streptococcus pyogenes, Streptococcus agalactiae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 weeks
Secondary outcomes (2)
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.
Measured: up to12 weeks
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.
Measured: 12 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jun 2022
- Primary completionApr 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,040 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365711
- Sponsor's protocol ID
- 67/1801/2021
- Status last verified
- Mar 2024
- First submitted
- 26 Apr 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carriage of Beta Haemolytic Streptococci During Pregnancy
- ClinicalTrials.gov ID
- NCT05365711
- Acronym / sponsor ID
- 67/1801/2021
- Conditions
- Pregnancy Related
- Keywords
- pregnancy, group a streptococci, group b streptococci, carriage, microbiota, Streptococcus pyogenes, Streptococcus agalactiae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- pregnant women
- partner of the pregnant women
- over/equal 18 years of age
- willing to participate the study
Key exclusion criteria (2 listed)
- multiple pregnancy
- age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Pregnancy or delivery related infections/complications
Time frame: up to12 weeks
Infections/complications of newborn
Time frame: 12 weeks after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carriage of beta haemolytic streptococci (time frame: up to 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.