Gestational MotherPROBIGESTNCT03671486
Colonization with Group B Streptococcus During Pregnancy
An observational study of Gestational Mother and Streptococcus Agalactiae Infection, run by ProbiSearch SL at 1 site in Spain.
Trial summary
An observational study to estimate the probability of pregnant women, who were GBS-negative in the first trimester of pregnancy become GBS-positive at the end of pregnancy. It is an observational. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Mother, Streptococcus Agalactiae Infection
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2018to 9 Sep 2020
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 100 pregnant women GBS (-)
Who may be able to join
- Healthy pregnant women, adults (≥ 18 years and under 45 years). Before/during week 13 of gestation. Signing of informed consent.
Who cannot join
- Multiple pregnancy.
- Fetal complications.
- History of premature delivery/miscarriage in the second trimester. Significant maternal medical complications.
- HIV-positive.
- Women who are immunocompromised (for example, patients with cancer and transplant who are taking certain immunosuppressive drugs, patients with hereditary diseases that affect or could affect the immune system).
- History of significant gastrointestinal disease (e.g., prior gastrointestinal resection, current diarrhea, inflammatory bowel disease).
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- Heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever or cardiac malformation).
- Use of other probiotics during the current pregnancy.
- Uncertainty of the investigator regarding the willingness or capacity of the participant to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Investigate the Probability of Colonization with Group B Streptococcus (GBS) of Pregnant Women Who Were Negative for GBS in the First Trimester of Pregnancy
An observational study to estimate the probability of pregnant women, who were GBS-negative in the first trimester of pregnancy become GBS-positive at the end of pregnancy. It is an observational. One hundred pregnant women in the first trimester of pregnancy (11 ± 2 weeks) will be invite to participate in this prospective study. If accept, a vagino-rectal swab will collected for a GBS detection analysis. When negative, participants will be follow by their gynecologist with the normal routine procedures. During 35 week of pregnancy a vagino-rectal swab will be collected and analyzed to detect GBS. Then, a final visit will be completed one month after delivery.
Read the detailed description
Healthy pregnant women reporting to the clinic in their first trimester of pregnancy (week 11 ± 2 weeks of pregnancy) will be asked to participate in this study. Participation will be voluntary and written informed consent will be obtained from each participant. The study visits will take place in the hospital.
At Visit 1, the inclusion and exclusion criteria will be verified. After signing the informed consent, a physical examination will be performed in addition to a vaginal-rectal swab to detect if they are GBS-negative. Information on the demographic profile and medical history will be collected. The investigator will explain to the participant that she cannot use any probiotic during the course of the study.
At Visit 2, within 21-23 weeks ± 4 days of gestation, the inclusion and exclusion criteria will be reviewed. If the result of the microbiological analysis of the vaginal-rectal exudate is negative, the pregnant women shall continue in the study. A physical examination will be performed. Adverse Events occurring from the time of study inclusion will be recorded.
At the third visit (Visit 3, 35 weeks ± 4 days of gestation), all participants continuing in the study will undergo a general physical examination. A sample of vagino-rectal exudate will be collected. Adverse Events occurring during the period between Visit 2 and Visit 3 will be recorded.
During Visit 4 (1 month after delivery), all participants will have a general physical examination. Adverse Events occurring since Visit 3 will be recorded. Data will be collected on the delivery and occurrence of early- or late-onset GBS sepsis in the newborn during the first month of life.
- Medical subject headings
- Streptococcal Infections
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 |
|---|---|---|
| GBS-negative pregnant women | One Hundred Healthy GBS-negative pregnant women will be follow-up since the first trimester of pregnancy until one month post-delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants (%) with a vaginal-rectal detection of Group B Streptococcus.
Percentage of participants with a vaginal-rectal detection of Group B Streptococcus at the end of the study.
Measured: 6 months
Secondary outcomes (7)
Composition of the microbiota of vaginal-rectal exudates
Amounts (log(CFU/mL) and identification of bacterial species detected by culture in vaginal-rectal exudates from pregnant women
Measured: 6 months
Premature membrane rupture
% of participants with premature rupture of the membranes
Measured: 7 months
Premature detachment of the placenta
% of participants with premature detachment of the placenta
Measured: 7 months
Premature delivery
% of participants with premature delivery
Measured: 7 months
Pregnancy complications
% of participants with pregnacy complications
Measured: 7 months
Newborns with early onset sepsis
Percentage of newborns with early onset sepsis
Measured: 7 months
Newborns with late onset sepsis
Percentage of newborns with late onset sepsis
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start5 Dec 2018
- Primary completion13 Jul 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational MotherStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Casen Recordati S.L.
- Responsible party
- Sponsor
- Investigators
- Susana Manzano, PhD, Study chair, ProbiSearch SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671486
- Sponsor's protocol ID
- STB/17.02.1
- Acronym
- PROBIGEST
- Status last verified
- Oct 2020
- First submitted
- 30 Aug 2018
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Investigate the Probability of Colonization with Group B Streptococcus (GBS) of Pregnant Women Who Were Negative for GBS in the First Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT03671486
- Acronym / sponsor ID
- PROBIGEST / STB/17.02.1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Collaborators
- Casen Recordati S.L.
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 14 Sep 2018 (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.
An observational study to estimate the probability of pregnant women, who were GBS-negative in the first trimester of pregnancy become GBS-positive at the end of pregnancy. It is an observational. One hundred pregnant women in the first trimester of pregnancy (11 ± 2 weeks) will be invite to participate in this prospective study. If accept, a vagino-rectal swab will collected for a GBS detection analysis. When negative, participants will be follow by their gynecologist with the normal routine procedures. During 35 week of pregnancy a vagino-rectal swab will be collected and analyzed to detect GBS. Then, a final visit will be completed one month after delivery.
Detailed description
Healthy pregnant women reporting to the clinic in their first trimester of pregnancy (week 11 ± 2 weeks of pregnancy) will be asked to participate in this study. Participation will be voluntary and written informed consent will be obtained from each participant. The study visits will take place in the hospital.
At Visit 1, the inclusion and exclusion criteria will be verified. After signing the informed consent, a physical examination will be performed in addition to a vaginal-rectal swab to detect if they are GBS-negative. Information on the demographic profile and medical history will be collected. The investigator will explain to the participant that she cannot use any probiotic during the course of the study.
At Visit 2, within 21-23 weeks ± 4 days of gestation, the inclusion and exclusion criteria will be reviewed. If the result of the microbiological analysis of the vaginal-rectal exudate is negative, the pregnant women shall continue in the study. A physical examination will be performed. Adverse Events occurring from the time of study inclusion will be recorded.
At the third visit (Visit 3, 35 weeks ± 4 days of gestation), all participants continuing in the study will undergo a general physical examination. A sample of vagino-rectal exudate will be collected. Adverse Events occurring during the period between Visit 2 and Visit 3 will be recorded.
During Visit 4 (1 month after delivery), all participants will have a general physical examination. Adverse Events occurring since Visit 3 will be recorded. Data will be collected on the delivery and occurrence of early- or late-onset GBS sepsis in the newborn during the first month of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBS-negative pregnant women | – | –One Hundred Healthy GBS-negative pregnant women will be follow-up since the first trimester of pregnancy until one month post-delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 pregnant women GBS (-)
Key inclusion criteria (1 listed)
- Healthy pregnant women, adults (≥ 18 years and under 45 years). Before/during week 13 of gestation. Signing of informed consent.
Key exclusion criteria (9 listed)
- Multiple pregnancy.
- Fetal complications.
- History of premature delivery/miscarriage in the second trimester. Significant maternal medical complications.
- HIV-positive.
- Women who are immunocompromised (for example, patients with cancer and transplant who are taking certain immunosuppressive drugs, patients with hereditary diseases that affect or could affect the immune system).
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
Participants (%) with a vaginal-rectal detection of Group B Streptococcus.
Time frame: 6 months
Percentage of participants with a vaginal-rectal detection of Group B Streptococcus at the end of the study.
7 secondary outcomes
Composition of the microbiota of vaginal-rectal exudates
Time frame: 6 months
Premature membrane rupture
Time frame: 7 months
Premature detachment of the placenta
Time frame: 7 months
Premature delivery
Time frame: 7 months
Pregnancy complications
Time frame: 7 months
Newborns with early onset sepsis
Time frame: 7 months
Newborns with late onset sepsis
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Susana Manzano, PhD study chair
ProbiSearch SL
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 Gestational Mother and Streptococcus Agalactiae Infection, run by ProbiSearch SL at 1 site in Spain.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 7 Nov 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participants (%) with a vaginal-rectal detection of Group B Streptococcus. (time frame: 6 months). 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 7 Nov 2024.