Status:
COMPLETED
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
Lead Sponsor:
Stanford University
Conditions:
Infection
Pregnancy
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief 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 dec...
Detailed Description
1. Screening: All pregnant women prior to 28 weeks gestational age. Patients who choose to enroll and who will not deliver at Lucile Packard Childrens Hospital at Stanford will sign release of medical...
Eligibility Criteria
Inclusion
- Pregnant women between 20-28 weeks gestation.
- 18 years of age or older.
- Singleton gestation.
Exclusion
- 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)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2017
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT01479478
Start Date
November 1 2011
End Date
July 26 2017
Last Update
August 20 2018
Active Locations (3)
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1
Aptos Women's Health Center
Aptos, California, United States, 95003
2
Dominican Hospital
Santa Cruz, California, United States, 95065
3
Stanford University School of Medicine/Lucile Packard Children's Hospital
Stanford, California, United States, 94305