Colonization with Group B Streptococcus During Pregnancy

NCT03671486 | Completed

• 1 other identifier: STB/17.02.1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gestational Mother; Streptococcus Agalactiae Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Composition of the microbiota of vaginal-rectal exudates

  6 months

• Premature membrane rupture

  7 months

• Premature detachment of the placenta

  7 months

• Premature delivery

  7 months

• Pregnancy complications

  7 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 pregnant women GBS (-)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ProbiSearch SL: lead
• Casen Recordati S.L.: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vagino-rectal exudate from participant will be collected at visit 1 and 3 to detect the presence of Group B Streptococcus. After that, they will be destroyed.

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Susana Manzano, PhD

  ProbiSearch SL

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 14, 2018
• Study Start: December 5, 2018
• Primary Completion: July 13, 2020
• Study Completion: September 9, 2020
• Last Updated: November 7, 2024

Record last verified: 2020-10

Locations

ES (1)