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BUNDLE Trial: Evaluate the effectiveness of a pragmatic trial of lifestyle modifications reducing pregnancy Group B Streptococcus colonization in pregnancy- A Midwifery Led Initiative

Evaluate the effectiveness of a pragmatic trial of lifestyle modifications reducing pregnancy Group B Streptococcus colonization in pregnancy- A Midwifery Led Initiative

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000969561
Acronym
BUNDLE
Enrollment
100
Registered
2024-08-09
Start date
2024-08-12
Completion date
2024-12-09
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is an interventional study. One arm is assigned to an intervention group, which entails health and lifestyle adjustments to see the effect on GBS colonisation in pregnancy. Both arms of the study will involve observation throughout pregnancy. The intervention study arm will be asked to undertake a 'bundle' of interventions-: • take vitamin D supplements if their levels are low (<50mmol) • take an oral probiotic daily • limit sugar intake (<30gms/day) • increasing pre/probiotic food intake (5 x week) • increase exercise to 3 hours per week • Complete a weekly survey to ascertain compliance • Participate in GBS Screening at 35-37 weeks as part of antenatal care Our hypothesis is that women in the intervention group will have lower rates of GBS at the 35-37 week screening.

Interventions

The BUNDLE intervention grouped women: -Vit D will be advised if they are below accepted levels in pregnancy (50nmol/L), of which every women undergoes blood testing as part of routine pregnancy care, in early pregnancy. Women will be advised what supplements to take by their pregnancy health care provider. -A daily probiotic, taken once daily, orally, throughout the entire pregnancy. The probiotic recommended is GastroHealth Women's health Probiotic (Lactobacillus rhamnosus (HN001) 2 billion CF

The BUNDLE intervention grouped women: -Vit D will be advised if they are below accepted levels in pregnancy (50nmol/L), of which every women undergoes blood testing as part of routine pregnancy care, in early pregnancy. Women will be advised what supplements to take by their pregnancy health care provider. -A daily probiotic, taken once daily, orally, throughout the entire pregnancy. The probiotic recommended is GastroHealth Women's health Probiotic (Lactobacillus rhamnosus (HN001) 2 billion CFU, Lactobacillus rhamnosus (GG) 5 billion CFU, Lactobacillus acidophilus (La-14) 8 billion CFU, Inulin 40mg. -An exercise plan of 3 hours per week, and record intensity of low, medium and high, or roughly 30 minutes, 6 days a week, through the pregnancy. Any intensity the women are comfortable with is adequate and recorded. - A dietary plan will be recommended. Foods with natural probiotic and prebiotic qualities such as yoghurts, kefir, kombucha, sauerkraut, pickles, miso, tempeh, kimchi, sourdough bread and garlic, onions, asparagus, leeks and bran will be recommended 5 times per week and recorded for the entire pregnancy. -As part of the dietary plan, women will be advised to limit sugar intake to a maximum of 30gms er day, this will be recorded in the weekly survey also. -Receive information booklet with suggested probiotics, foods and exercise regimes that are research based and considered safe in pregnancy as a reference guide. This booklet has been specifically developed for women in this study. -Compliance will be ascertained with a weekly questionnaire, sent via phone and asking adherence to each aspect of the study for that week. -Women will have to undergo GBS screening at their routine 35–37-week antenatal appointments, as pe the WA health recommendation. Women who decline GBS screening in pregnancy will be excluded from this study. The interventions will be undertaken from enrolment (<24 weeks) until birth. The women will be given all the information (the booklet as aforementioned) required about their interventions upon consent. The women will be allocated to the intervention arm or the non-intervention arm, dependant on their willingness to implement the bundle of interventions. The mode of intervention will be through the research midwife and monitored by once weekly survey/questionnaires ascertaining compliance. The Group B Streptococcus (GBS) screening will be undertaken as per hospital policy- which is currently a self obtained recto-vaginal swab given to Health Care providers at their routine antenatal appointment. The Health Care providers then send it to the lab for cultures.

Sponsors

Fiona Stanley Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026