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Trial registered on ANZCTR
Registration number
ACTRN12624000969561
Ethics application status
Approved
Date submitted
11/07/2024
Date registered
9/08/2024
Date last updated
9/08/2024
Date data sharing statement initially provided
9/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
BUNDLE Trial: Evaluate the effectiveness of a pragmatic trial of lifestyle modifications reducing pregnancy Group B Streptococcus colonization in pregnancy- A Midwifery Led Initiative
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Scientific title
Evaluate the effectiveness of a pragmatic trial of lifestyle modifications reducing pregnancy Group B Streptococcus colonization in pregnancy- A Midwifery Led Initiative
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Secondary ID [1]
312514
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none
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Universal Trial Number (UTN)
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Trial acronym
BUNDLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pregnancy
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Group B streptococcal colonisation
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Condition category
Condition code
Reproductive Health and Childbirth
331022
331022
0
0
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Antenatal care
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Infection
331097
331097
0
0
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Other infectious diseases
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Reproductive Health and Childbirth
331098
331098
0
0
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Complications of newborn
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Reproductive Health and Childbirth
331099
331099
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0
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Normal pregnancy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
329035
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Lifestyle
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Intervention code [2]
329085
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Behaviour
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Comparator / control treatment
Standard care without BUNDLE interventions above.
Routine antenatal appointments. Nil probiotic intake, nil additional exercise or any at all, no limit on sugar intake, no advice on dietary intake. Appointments with healthcare professionals at routine intervals and no advice on any of these interventions, with the exception of Vitamin D, which is to be above 50nmol/l or supplement with additional Vitamin D, orally.
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Control group
Active
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Outcomes
Primary outcome [1]
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Group B Streptococcus (GBS) maternal rectovaginal colonisation in pregnancy
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Assessment method [1]
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Positive culture of rectovaginal swab
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Timepoint [1]
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Group B Streptococcus (GBS) maternal rectovaginal colonisation indicated by positive
culture of rectovaginal swab at 35-37 weeks gestation
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Secondary outcome [1]
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Development of Gestational Diabetes
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Assessment method [1]
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Oral Glucose tolerance test
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Timepoint [1]
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28 weeks of pregnancy
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Eligibility
Key inclusion criteria
1. Pregnant women 15- 24 weeks gestation
2. 18-45 years of age,
3. Singleton gestation
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patient selected- they are willing to implement interventions, they are assigned to the interventional arm, if they are not willing they are assigned to the observational arm. This is not a blind trial.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
12/08/2024
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Actual
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Date of last participant enrolment
Anticipated
9/12/2024
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Actual
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Date of last data collection
Anticipated
30/04/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [2]
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Rockingham General Hospital - Cooloongup
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Recruitment postcode(s) [1]
42836
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6150 - Murdoch
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Recruitment postcode(s) [2]
42837
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6168 - Cooloongup
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Funding & Sponsors
Funding source category [1]
316938
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Charities/Societies/Foundations
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Name [1]
316938
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Spinnaker Foundation
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Address [1]
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Country [1]
316938
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Australia
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Primary sponsor type
Hospital
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Name
Fiona Stanley Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319184
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None
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Name [1]
319184
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Address [1]
319184
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Country [1]
319184
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315690
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
315690
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https://smhs.health.wa.gov.au/Our-research/For-researchers
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Ethics committee country [1]
315690
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Australia
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Date submitted for ethics approval [1]
315690
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04/03/2024
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Approval date [1]
315690
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29/03/2024
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Ethics approval number [1]
315690
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Nicole Catalano
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Address
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6150, WA
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Country
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Australia
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Phone
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+61403909285
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Nicole Catalano
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Address
135515
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6150, WA
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Country
135515
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Australia
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Phone
135515
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+61 961522222
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Fax
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Email
135515
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[email protected]
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Contact person for scientific queries
Name
135516
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Nicole Catalano
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Address
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6150, WA
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Country
135516
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Australia
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Phone
135516
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+61 861522222
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Fax
135516
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Email
135516
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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