Colonization With Group B Streptococcus During Pregnancy (PROBIGEST)

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.

Study Overview

• Status: Completed
• Conditions: Gestational Mother; Streptococcus Agalactiae Infection

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

100 pregnant women GBS (-)

Description

Inclusion Criteria:

Healthy pregnant women, adults (≥ 18 years and under 45 years). Before/during week 13 of gestation. Signing of informed consent.

Exclusion Criteria:

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).

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborns with early onset sepsis	Percentage of newborns with early onset sepsis	7 months
Newborns with late onset sepsis	Percentage of newborns with late onset sepsis	7 months
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	6 months
Premature membrane rupture	% of participants with premature rupture of the membranes	7 months
Premature detachment of the placenta	% of participants with premature detachment of the placenta	7 months
Premature delivery	% of participants with premature delivery	7 months
Pregnancy complications	% of participants with pregnacy complications	7 months

Collaborators and Investigators

• Sponsor: ProbiSearch SL
• Collaborators: Casen Recordati S.L.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2018
• Primary Completion (ACTUAL): July 13, 2020
• Study Completion (ACTUAL): September 9, 2020

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (ACTUAL): September 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: STB/17.02.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No