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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
Scientific title
Evaluate the effectiveness of a pragmatic trial of lifestyle modifications reducing pregnancy Group B Streptococcus colonization in pregnancy- A Midwifery Led Initiative
Secondary ID [1] 312514 0
none
Universal Trial Number (UTN)
Trial acronym
BUNDLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 334381 0
Group B streptococcal colonisation 334382 0
Condition category
Condition code
Reproductive Health and Childbirth 331022 331022 0 0
Antenatal care
Infection 331097 331097 0 0
Other infectious diseases
Reproductive Health and Childbirth 331098 331098 0 0
Complications of newborn
Reproductive Health and Childbirth 331099 331099 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329035 0
Lifestyle
Intervention code [2] 329085 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 338787 0
Group B Streptococcus (GBS) maternal rectovaginal colonisation in pregnancy
Timepoint [1] 338787 0
Group B Streptococcus (GBS) maternal rectovaginal colonisation indicated by positive
culture of rectovaginal swab at 35-37 weeks gestation
Secondary outcome [1] 437457 0
Development of Gestational Diabetes
Timepoint [1] 437457 0
28 weeks of pregnancy

Eligibility
Key inclusion criteria
1. Pregnant women 15- 24 weeks gestation
2. 18-45 years of age,
3. Singleton gestation
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/08/2024
Actual
Date of last participant enrolment
Anticipated
9/12/2024
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26787 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 26788 0
Rockingham General Hospital - Cooloongup
Recruitment postcode(s) [1] 42836 0
6150 - Murdoch
Recruitment postcode(s) [2] 42837 0
6168 - Cooloongup

Funding & Sponsors
Funding source category [1] 316938 0
Charities/Societies/Foundations
Name [1] 316938 0
Spinnaker Foundation
Country [1] 316938 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
Country
Australia
Secondary sponsor category [1] 319184 0
None
Name [1] 319184 0
Address [1] 319184 0
Country [1] 319184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315690 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315690 0
https://smhs.health.wa.gov.au/Our-research/For-researchers
Ethics committee country [1] 315690 0
Australia
Date submitted for ethics approval [1] 315690 0
04/03/2024
Approval date [1] 315690 0
29/03/2024
Ethics approval number [1] 315690 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135514 0
Mrs Nicole Catalano
Address 135514 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6150, WA
Country 135514 0
Australia
Phone 135514 0
+61403909285
Fax 135514 0
Email 135514 0
[email protected]
Contact person for public queries
Name 135515 0
Nicole Catalano
Address 135515 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6150, WA
Country 135515 0
Australia
Phone 135515 0
+61 961522222
Fax 135515 0
Email 135515 0
[email protected]
Contact person for scientific queries
Name 135516 0
Nicole Catalano
Address 135516 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6150, WA
Country 135516 0
Australia
Phone 135516 0
+61 861522222
Fax 135516 0
Email 135516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.