Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy

Summary

The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal antibiotic administration at time of labor. The importance of this study is that it may offer a safer alternative to antibiotic treatment of group B Streptococcus (GBS) colonized pregnant women.

Timeline

Start

2011-11

Primary completion

2017-07-26

Completion

2017-07-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Probiotic Dietary Supplement vs Placebo; p = 0.87; Cochran-Mantel-Haenszel NCT01479478 ↗

Drugs

Indications