BUNDLE Trial: Evaluate the effectiveness of a pragmatic trial of lifestyle modifications reducing pregnancy Group B Streptococcus colonization in pregnancy- A Midwifery Led Initiative
Not Applicable
- Conditions
- pregnancyGroup B streptococcal colonisationReproductive Health and Childbirth - Antenatal careInfection - Other infectious diseasesReproductive Health and Childbirth - Complications of newbornReproductive Health and Childbirth - Normal pregnancy
- Registration Number
- ACTRN12624000969561
- Lead Sponsor
- Fiona Stanley Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
1. Pregnant women 15- 24 weeks gestation
2. 18-45 years of age,
3. Singleton gestation
Exclusion Criteria
1. Pre-existing morbidity, including but not limited to:
Type 1 diabetes and type 2 diabetes, disease requiring antibiotic prophylaxis during procedure/labour; pulmonary disease (except mild asthma)
2. Multi-fetal pregnancy
3. Chronic (daily) use of broad-spectrum antibiotics.
4. History of infant with GBS sepsis
5. Intrauterine Growth Restriction (IUGR), Fetal Anomalies-major diagnosed at time of second
trimester anatomy ultrasound
6. Anticipated delivery <35 weeks for maternal/fetal indication
7. Placenta Previa or accreta (with anticipated delivery prior to 35 weeks)
8. Not wishing to test for GBS at 35-37 weeks as per schedule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method