Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000179831
Ethics application status
Approved
Date submitted
8/12/2020
Date registered
22/02/2021
Date last updated
22/02/2021
Date data sharing statement initially provided
22/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of Australian bushfires on pregnant and breastfeeding women in the Mid North Coast Local Health District (MNCLHD) New South Wales.
Scientific title
The health impact of Australian bushfires on pregnant and breastfeeding women with and without asthma, in the MNCLHD.
Secondary ID [1] 302959 0
None
Universal Trial Number (UTN)
U1111-1262-4642
Trial acronym
Nil known
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Respiratory symptoms 320023 0
Maternal wellbeing 320025 0
Pregnancy 320364 0
Breast feeding 320815 0
Asthma 320816 0
Condition category
Condition code
Public Health 317944 317944 0 0
Other public health
Respiratory 318639 318639 0 0
Asthma
Reproductive Health and Childbirth 318640 318640 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 318643 318643 0 0
Breast feeding

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a cross-sectional survey with longitudinal follow up of pregnant and/or breastfeeding women with asthma and without asthma, and health outcomes of their infants. The aim is to better understand the experiences and impacts of the 2019/2020 bushfires on the health and wellbeing of this population. Further, it also examines the impacts on this cohort leading into the 2020/2021 bushfire season, notably evaluating wellbeing, and maternal concerns and behaviours (e.g. exposure reduction strategies, medication use, and infant feeding practices).
The study will be conducted primarily online using REDCap survey software. The survey will be distributed to participants who have registered and provided informed consent using a web-based platform, paper-based survey or verbally (via telephone). Participants will receive a web-link via email or telephone call to complete the survey.
Follow up surveys will also be conducted in January and May 2021, exploring the impact on this cohort regarding their preparedness, health and wellbeing during the subsequent 2020/2021 bushfire season. Participants will receive a follow-up survey invitation (via email or text message), providing information on accessing the follow-up survey through an online link, mailed out a paper-based survey or via a telephone call. The initial questionnaire will take approximately 25-30 minutes to complete. Follow-up surveys will take approximately 20 minutes each. The initial survey was administered on 28th December 2020.
Intervention code [1] 319259 0
Not applicable
Comparator / control treatment
no control group.
Women without asthma are a reference group.

Control group
Active

Outcomes
Primary outcome [1] 325952 0
Composite primary outcome:
The experiences of women with and without asthma who were pregnant and/or breastfeeding during the 2019/20 bushfire season, notably evaluating the impact of smoke exposure on respiratory symptoms, wellbeing, and maternal concerns and behaviours (e.g. exposure reduction strategies, medication use, and infant feeding practices) through baseline and follow up surveys.
Timepoint [1] 325952 0
At the completion of all surveys.
Participants completed the baseline survey on 7 January 2021.
Follow-up survey 1 from 18 January to 31 March 2021.
Follow-up survey2 from 17 May to 31 July 2021.
Secondary outcome [1] 389643 0
Assess the impact of bushfire smoke exposure on infant health through baseline and follow up surveys.
Timepoint [1] 389643 0
At the completion of all surveys. Participants completed the baseline survey on 7 January 2021.
Follow-up survey 1 from 18 January to 31 March 2021.
Follow-up survey2 from 17 May to 31 July 2021.

Eligibility
Key inclusion criteria
All women that meet the inclusion criteria below;
1. Women 18 years of age or older
2. Residing in MNCLHD, NSW, Australia during the 2019/2020 Bushfire season, between July 2019 – March 2020.
3. Pregnant and /or breastfeeding during the 2019/2020 Bushfire season
4. For the asthma group, a previous doctor diagnosis of asthma is required
5. If you are completing this as a non-asthma participant this means you do not or never have had a diagnosis of asthma
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to describe the demographic characteristics, general health and pregnancy and breastfeeding practice of the study participants. Exposure estimates (particulate matter) will be reported as medians with interquartile ranges (IQR). The exposure data will be assigned according to the participant's residence. Outcome data collected during the bushfire season and subsequent bushfire period will be compared between study participants. Differences between study participants will be ascertained utilizing Pearson’s chi-squared (for categorical variables) and independent t-test (for continuous variables).
The multivariable log-binomial generalized linear regression model will be used to estimate the impact of bushfire smoke exposure on self-reported health outcomes during the 2019/2020 Australian bushfire season compared to post bushfire season. The model fit will be assessed by applying Hosmer – Lemeshow, the person chi-square and the unweighted sum of squares test. Further, Akaike information criteria (AIC) will be applied to inform model selection. Overall effects will be assessed using the risk ratio (RR) and 95% confidence intervals (95% CI) for self-reported health outcomes. Further, stratified analysis by history of asthma will be performed to assess the different effects of bushfire smoke exposure on women with asthma and without asthma.
The effect of bushfire smoke exposure on self-reported health outcomes during 2019/20 bushfire season compared to 2020/2021 bushfire season will be examined using generalized linear regression model. RR with 95% CI will be used to determine the strength of the association. Sensitivity analysis will be conducted to examine the soundness of the findings, which includes restricting the analysis to women with asthma and who seek health advice during the bushfire season. Further, separate analysis will be performed to evaluate the possible difference in women who take actions to reduce exposure to smoke during the bushfire seasons.
The State-Trait Anxiety Inventory for Adults (STAIAD) will be used to assess women wellbeing (anxiety level) during and after the 2019/2020 bushfire season. The current study will employ STAIAD consists of six items with a response based on a self-reported four-point Likert scale (“Not at all”, “Somewhat”, “Moderately so”, “Very much so”). Standardized cut-off scores will be used to assess the level of anxiety. A higher score of STAIAD indicates a higher level of anxiety. The multivariable linear regression model will be used to calculate the RR for the level of anxiety associated with bushfire smoke during the 2019/2020 bushfire season compared to post bushfire. Further, the impact of bushfire smoke on anxiety level during 2019/20 bushfire season compared to 2020/2021 bushfire season will be reported using RR with 95% CI. A separate analysis will also be performed to determine the association between bushfire smoke exposure and level of anxiety for women with asthma and without asthma.
The association between women exposure to bushfire smoke and pregnancy outcomes, such as gestational diabetes, pregnancy-induced hypertension, low birth weight, preterm birth and parent-reported infant health outcomes will be calculated using generalized linear regression model. The results will be reported as RR with 95% CIs. Stratified analysis by a history of asthma will also be employed to assess the effects of exposure to bushfire smoke on parent-reported health outcomes.



Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
27/11/2020
Date of last participant enrolment
Anticipated
Actual
7/01/2021
Date of last data collection
Anticipated
31/07/2021
Actual
Sample size
Target
261
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307377 0
University
Name [1] 307377 0
University of Newcastle
Country [1] 307377 0
Australia
Primary sponsor type
Individual
Name
Professor Vanessa M. McDonald
Address
School of Nursing and Midwifery
Faculty of Health and Medicine
University of Newcastle
Level 2 Hunter Medical Research Institute, 1 Kookaburra Circuit, New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 308048 0
None
Name [1] 308048 0
Address [1] 308048 0
Country [1] 308048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307464 0
North Coast NSW Human Research Ethics Committee
Ethics committee address [1] 307464 0
Ethics committee country [1] 307464 0
Australia
Date submitted for ethics approval [1] 307464 0
Approval date [1] 307464 0
28/10/2020
Ethics approval number [1] 307464 0
HREA297

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107326 0
Prof Vanessa M. McDonald
Address 107326 0
Professor of Nursing
School of Nursing and Midwifery
Faculty of Health and Medicine
University of Newcastle
Level 2 Hunter Medical Research Institute, 1 Kookaburra Circuit, New Lambton Heights, NSW 2305.
Country 107326 0
Australia
Phone 107326 0
+61 02 4042 0146
Fax 107326 0
Email 107326 0
Vanessa.McDonald@newcastle.edu.au
Contact person for public queries
Name 107327 0
Tesfalidet Beyene
Address 107327 0
Postdoctoral Research Fellow
School of Medicine and Public Health
University of Newcastle
University Drive, Callaghan, NSW,2308
Country 107327 0
Australia
Phone 107327 0
+61 02 4042 0764
Fax 107327 0
Email 107327 0
Tesfalidet.Beyene@newcastle.edu.au
Contact person for scientific queries
Name 107328 0
Tesfalidet Beyene
Address 107328 0
Postdoctoral Research Fellow
School of Medicine and Public Health
University of Newcastle
University Drive, Callaghan, NSW,2308
Country 107328 0
Australia
Phone 107328 0
+61 02 4042 0764
Fax 107328 0
Email 107328 0
Tesfalidet.Beyene@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individualised data will be available on completion of the study.


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.