N/A
N=251
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
Infection · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT01479478 ↗Enrolled (actual)
251
Serious AEs
0.4%
Results posted
Aug 2018
Primary outcome: Primary: Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age — 20; 23 Participants — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo (Drug); Probiotic dietary supplement (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age |
20; 23 | 0.87 |
| SECONDARY Count of Participants With Urinary Tract Infection |
8; 9 | — |
| SECONDARY Count of Participants With Intrapartum Chorioamnionitis |
5; 4 | — |
| SECONDARY Count of Participants With Endometritis |
0; 2 | — |
| SECONDARY Count of Participants With Cellulitis |
0; 0 | — |
| SECONDARY Count of Participants With Bacteremia |
0; 0 | — |
| SECONDARY Count of Participants With Sepsis |
0; 0 | — |
| SECONDARY Count of Participants With Other Infectious Morbidity |
0; 0 | — |
| SECONDARY Gestational Age at Delivery |
39.6; 39.4 | — |
| SECONDARY Apgar Score at 1 and 5 Minutes Following Delivery |
8; 8; 9; 9 | — |
| SECONDARY Neonatal Bilirubin Level |
6.4; 6.5 | — |
| SECONDARY Neonatal C-reactive Protein Level |
1.6; 1.2 | — |
| SECONDARY Count of Neonates Requiring a "Rule-out Sepsis Evaluation" |
9; 4 | — |
| SECONDARY Count of Neonates With Sepsis |
4; 1 | — |
| SECONDARY Count of Neonates With Pneumonia |
0; 0 | — |
| SECONDARY Count of Neonates With Meningitis |
0; 0 | — |
| SECONDARY Count of Neonates With Intensive-care Unit Admission |
12; 7 | — |
| SECONDARY Length of Neonatal Hospital Stay |
2; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pregnant women between 20-28 weeks gestation.
- 18 years of age or older.
- Singleton gestation.
Exclusion Criteria
- Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ transplant; chronic steroid therapy; autoimmune disease requiring treatment during pregnancy, and other immunocompromised states); Type 1 diabetes and type 2 diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic prophylaxis during procedure/labor; pulmonary disease (except mild asthma); renal disease; chronic hepatic disease (Hepatitis B, C); inflammatory bowel disease (Crohn's disease or ulcerative colitis); stomach or duodenal ulcer; bowel resection, gastric bypass, and chronic indwelling venous, bladder, or gastric catheter.
- Multi-fetal gestation.
- Use of probiotics preparations in the 3 months prior to beginning of the study treatment or use of any additional probiotics preparations (other than study treatment) at any time during the study period (including over the counter food supplements such as Activia, BioK, other oral or vaginal probiotics products (BUT not including other common forms of yogurt).
- Chronic (daily) use of broad spectrum antibiotics.
- History of infant with GBS sepsis.
- Intrauterine Growth Restriction (IUGR), Fetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound
- Anticipated delivery <35 wks for maternal/fetal indication
- Placenta previa or accreta (with anticipated delivery prior to 35 weeks)
Data sourced from ClinicalTrials.gov (NCT01479478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.