Colonization With Group B Streptococcus During Pregnancy

Streptococcus Agalactiae Infection Clinical Trial

— PROBIGEST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671486
• Other study ID #: STB/17.02.1
• Status: Completed
• Start date: December 5, 2018
• Est. completion date: September 9, 2020

Study information

• Verified date: October 2020
• Source: ProbiSearch SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 9, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gestational Mother
• Streptococcal Infections
• Streptococcus Agalactiae Infection

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
ProbiSearch SL	Casen Recordati S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Premature membrane rupture	% of participants with premature rupture of the membranes	7 months
Secondary	Premature detachment of the placenta	% of participants with premature detachment of the placenta	7 months
Secondary	Premature delivery	% of participants with premature delivery	7 months
Secondary	Pregnancy complications	% of participants with pregnacy complications	7 months
Secondary	Newborns with early onset sepsis	Percentage of newborns with early onset sepsis	7 months
Secondary	Newborns with late onset sepsis	Percentage of newborns with late onset sepsis	7 months