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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic dietary supplement | Active Comparator | Probiotic dietary supplement one capsule once per day until delivery. |
|
| Placebo | Placebo Comparator | Placebo capsule, one daily until delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | One placebo capsule daily. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age | Gestational age is given in a format of full weeks. | 35 to 37 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With Urinary Tract Infection | From enrollment up to delivery hospitalization (up to 42 weeks gestation) | |
| Count of Participants With Intrapartum Chorioamnionitis | Intrapartum chorioamnionitis is maternal temperature above 38.0 degrees Celsius and one or more of the following findings: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent or malodorous amniotic fluid, or elevated maternal white blood cell count. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natali Aziz, MD | Stanford University School of Medicine/Lucile Packard Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aptos Women's Health Center | Aptos | California | 95003 | United States | ||
| Dominican Hospital |
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Only expecting mothers were enrolled in this study. Neonatal data were collected from respective pregnancies, however, the neonates were not considered to be enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Probiotic Dietary Supplement | Probiotic dietary supplement one capsule once per day until delivery. Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14 |
| FG001 | Placebo | Placebo capsule, one daily until delivery. Placebo: One placebo capsule daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Probiotic Dietary Supplement | Probiotic dietary supplement one capsule once per day until delivery. Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age | Gestational age is given in a format of full weeks. | Participants with available data were included in the analysis | Posted | Count of Participants | Participants | 35 to 37 weeks gestational age |
|
From enrollment up to 6 weeks following delivery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Probiotic Dietary Supplement | Probiotic dietary supplement one capsule once per day until delivery. Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any other anticipated or unanticipated life-threatening event:intra-uterine fetal growth restriction | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natali Aziz, MD | Stanford University | 650-725-5720 | mfmresearch@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2013 | Jun 28, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2017 | Jul 5, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Probiotic dietary supplement | Dietary Supplement | Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14 |
|
|
| From time of labor onset until delivery (up to 42 weeks of gestation) |
| Count of Participants With Endometritis | Endometritis is a uterine (myometrial) infection. | From time of delivery up to 6 weeks postpartum |
| Count of Participants With Cellulitis | Cellulitis is a bacterial skin infection. | From time of delivery up to 6 weeks postpartum |
| Count of Participants With Bacteremia | Bacteremia is defined as presence of bacteria in the blood. | From time of labor onset up to 6 weeks postpartum |
| Count of Participants With Sepsis | Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated response of the body to an infection. | From labor onset up to 6 weeks postpartum |
| Count of Participants With Other Infectious Morbidity | Other infectious morbidity included maternal mastitis or pneumonia. | From time of labor onset up to 6 weeks postpartum |
| Gestational Age at Delivery | Gestational age at delivery is presented as weeks. | At time of delivery (up to 42 weeks of gestation) |
| Apgar Score at 1 and 5 Minutes Following Delivery | Apgar score is a measure to quickly assess the neonatal health status from time of delivery. Score ranges from 0-10. Lower scores correspond to worse health state; neonates with scores below 5 are considered to have poor prognosis. | At time of delivery (up to 42 weeks of gestation) |
| Neonatal Bilirubin Level | Up to 14 days following delivery |
| Neonatal C-reactive Protein Level | Maximum neonatal C-reactive protein level | Up to 14 days following delivery |
| Count of Neonates Requiring a "Rule-out Sepsis Evaluation" | Outcome was based on performance of neonatal blood culture. | Up to 14 days following delivery |
| Count of Neonates With Sepsis | Up to 14 days following delivery |
| Count of Neonates With Pneumonia | Up to 14 days following delivery |
| Count of Neonates With Meningitis | Up to 14 days following delivery |
| Count of Neonates With Intensive-care Unit Admission | Up to 14 days following delivery |
| Length of Neonatal Hospital Stay | Up to 14 days following delivery |
| Santa Cruz |
| California |
| 95065 |
| United States |
| Stanford University School of Medicine/Lucile Packard Children's Hospital | Stanford | California | 94305 | United States |
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pre-pregnancy Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Secondary | Count of Participants With Urinary Tract Infection | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | From enrollment up to delivery hospitalization (up to 42 weeks gestation) |
|
|
|
| Secondary | Count of Participants With Intrapartum Chorioamnionitis | Intrapartum chorioamnionitis is maternal temperature above 38.0 degrees Celsius and one or more of the following findings: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent or malodorous amniotic fluid, or elevated maternal white blood cell count. | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | From time of labor onset until delivery (up to 42 weeks of gestation) |
|
|
|
| Secondary | Count of Participants With Endometritis | Endometritis is a uterine (myometrial) infection. | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | From time of delivery up to 6 weeks postpartum |
|
|
|
| Secondary | Count of Participants With Cellulitis | Cellulitis is a bacterial skin infection. | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | From time of delivery up to 6 weeks postpartum |
|
|
|
| Secondary | Count of Participants With Bacteremia | Bacteremia is defined as presence of bacteria in the blood. | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | From time of labor onset up to 6 weeks postpartum |
|
|
|
| Secondary | Count of Participants With Sepsis | Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated response of the body to an infection. | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | From labor onset up to 6 weeks postpartum |
|
|
|
| Secondary | Count of Participants With Other Infectious Morbidity | Other infectious morbidity included maternal mastitis or pneumonia. | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | From time of labor onset up to 6 weeks postpartum |
|
|
|
| Secondary | Gestational Age at Delivery | Gestational age at delivery is presented as weeks. | Participants with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | weeks | At time of delivery (up to 42 weeks of gestation) |
|
|
|
| Secondary | Apgar Score at 1 and 5 Minutes Following Delivery | Apgar score is a measure to quickly assess the neonatal health status from time of delivery. Score ranges from 0-10. Lower scores correspond to worse health state; neonates with scores below 5 are considered to have poor prognosis. | Participants with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | At time of delivery (up to 42 weeks of gestation) |
|
|
|
| Secondary | Neonatal Bilirubin Level | Participants with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | mg/dL | Up to 14 days following delivery |
|
|
|
| Secondary | Neonatal C-reactive Protein Level | Maximum neonatal C-reactive protein level | Participants with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | mg/L | Up to 14 days following delivery |
|
|
|
| Secondary | Count of Neonates Requiring a "Rule-out Sepsis Evaluation" | Outcome was based on performance of neonatal blood culture. | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | Up to 14 days following delivery |
|
|
|
| Secondary | Count of Neonates With Sepsis | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | Up to 14 days following delivery |
|
|
|
| Secondary | Count of Neonates With Pneumonia | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | Up to 14 days following delivery |
|
|
|
| Secondary | Count of Neonates With Meningitis | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | Up to 14 days following delivery |
|
|
|
| Secondary | Count of Neonates With Intensive-care Unit Admission | Participants with available data were included in the analysis. | Posted | Count of Participants | Participants | Up to 14 days following delivery |
|
|
|
| Secondary | Length of Neonatal Hospital Stay | Participants with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | days | Up to 14 days following delivery |
|
|
|
| 0 |
| 125 |
| 1 |
| 125 |
| 0 |
| 125 |
| EG001 | Placebo | Placebo capsule, one daily until delivery. Placebo: One placebo capsule daily. | 0 | 126 | 0 | 126 | 0 | 126 |
|
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