Probiotics in Pregnancy and Group B Streptococcal Colonizatio

Recruiting

• Conditions: Group B Streptoccal Colonization in Pregnancy; Reproductive Health and Childbirth - Antenatal care; Infection - Other infectious diseases; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12615000239561
• Lead Sponsor: Fiona Stanley Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 460

Inclusion Criteria

1. Pregnant women between 23-28 weeks gestation.
2. 18-55 years of age
3. Singleton gestation

Exclusion Criteria

1. Pre-existing morbidity:
*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,
*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/labour; pulmonary disease (except mild asthma);
*renal disease;
*chronic hepatic disease (Hepatitis B, C);
2. Multi-foetal gestation.
3.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, other oral or vaginal probiotics products (BUT not including other common forms of yogurt).
4. Chronic (daily) use of broad spectrum antibiotics.
5. History of infant with GBS sepsis.
6. Foetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound
7. Anticipated delivery <35 weeks for maternal/foetal indication
8. Placenta Previa or accreta (with anticipated delivery prior to 35 weeks)
9. Women with a cognitive impairment, an intellectual disability or a mental illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Group B Streptococcus (GBS) maternal rectovaginal colonization indicated by positive culture of rectovaginal swab<br>[at 35-37 weeks of pregnancy<br>]

Secondary Outcome Measures

Name	Time	Method
eonatal GBS infection/meningitis - blood and or CSF culture (as needed clinically)[Birth to 28 days];Suspected or proven Neonatal non-GBS Sepsis - blood culture/CSF culture (as needed clinically)[Birth-28 days];Gestational Diabetes - Routine Maternal Blood sugar Screen (as normally indicated in pregancy)[26-28 weeks's gestation];Preeclampsia/Pregnancy Induced Hypertension - Clinical notes review for maternal BP [Recruitment to Delivery];Chorioamnionitis- Placental Culture[Delivery/Birth];Bacterial Vaginosis - vaginal swabs culture[Monthly from recuitment to delivery];Atopic Dermatitis/Eczema - Clinical diagnosis by Paediatrician/Neonatologist/Dermatologist and/or Blood test for IgE and/or skin prick testing (as needed clinically). This outcome applies to infants only.[8 weeks to one year of age];Preterm Birth : gestation less than 37 weeks based on Expected date of delivery[at Birth]