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Trial registered on ANZCTR


Registration number
ACTRN12621001211853
Ethics application status
Approved
Date submitted
25/02/2021
Date registered
10/09/2021
Date last updated
19/10/2022
Date data sharing statement initially provided
10/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the impact of caseload midwifery on preterm birth among vulnerable and disadvantaged women: a multi-centre randomised controlled trial
Scientific title
Exploring the impact of caseload midwifery on preterm birth among vulnerable and disadvantaged women: a multi-centre randomised controlled trial
Secondary ID [1] 301849 0
APP1200230
Universal Trial Number (UTN)
Trial acronym
MAGNOLIA (Midwifery CAseload Care – SupportinG Childbearing WomeN: A Randomised ContrOLled TrIAl)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Birth 318792 0
Low Birth Weight 320542 0
Caesarean Section 320543 0
Condition category
Condition code
Reproductive Health and Childbirth 316808 316808 0 0
Complications of newborn
Reproductive Health and Childbirth 316809 316809 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women randomised to the caseload intervention will receive antenatal, intrapartum and early postpartum care from a primary caseload midwife (with one or two antenatal visits conducted by a ‘back-up’ midwife if necessary). Women will receive midwifery care as per hospital guidelines and in conjunction with other health providers e.g., Obstetricians, Physicians, Allied Health as required. The number, frequency and duration of antenatal visits will be as per care provision to all maternity consumers. The difference will be that, unlike other forms of maternity care, where the woman sees various (mostly unknown) midwives throughout the pregnancy, birth and postpartum periods, primary care provision for women assigned to the trial arm will be from the caseload midwife (with medical input as needed). Women in the intervention arm will also be able to contact their primary midwife (or back-up midwife) 24 hours a day, 7 days per week if needed, and the midwife will be on-call to provide care during the woman’s labour and birth. In the postpartum period, the known caseload midwife will provide postnatal care and feeding support to the woman and her baby in hospital and will visit them in their home on discharge for follow-up care and support. Therefore, women who receive the intervention will be provided with continuity of care from a known midwife throughout pregnancy, labour, birth and postpartum; women assigned to standard care will receive care throughout their pregnancy, labour, birth and postpartum from midwives who are working on that day, who may or may not be known to her. The frequency of visits, content of visits, location of visits will be the same in both arms – care will be otherwise provided according to the same hospital guidelines and protocols for all women.

Data regarding the extent to which care was provided by the primary midwife will be collected primarily from the electronic medical record following the birth and from the women via telephone questionnaire at three months postpartum. To assess and compare continuity of carer, women in both trial arms will be asked about the presence of known care providers for labour, birth, postnatal hospital care and for their domiciliary care.

All relevant hospital guidelines and protocols will be followed when providing care for women in this study, including, but not limited to the Royal Women’s Hospital guidelines
- Labour and Birth and Early Puerperium – Care during 2018
- Standard Antenatal Check 2019
- Antenatal Care Schedule: hospital-led care 2020
- Postnatal Care and Documentation: Mother and Baby 2014

A nested sub-study will also explore the potential for differential physiological stress responses by trial arm at the Royal Women’s Hospital.

Consecutively randomised English-speaking women recruited at one site (the Royal Women’s Hospital) will be offered participation to this nested sub-study. Heart rate variability, sAA and sC biomarkers will be measured at baseline (i.e., before 20 weeks of pregnancy) and in later pregnancy (i.e., at 36 weeks gestation). To determine a between-group difference at any single timepoint, 200 women are needed (allocation ratio 1:1) to achieve power of 0.80 and an effect size of 0.4. Allowing for some loss to follow-up, 240 women will be recruited (i.e., 120 women in each arm).

Three biomarkers will be measured - a. salivary cortisol, b. salivary alpha-amylase, c. time and frequency domain heart rate variability using an electrocardiogram (ECG) recorder (i.e., Holter monitor).

Salivary cortisol concentrations will be calculated (in ng/mL) using an enzyme-linked immunosorbent assay (ELISA). Salivary alpha-amylase activity will be assayed using a Kinetic Enzyme Assay Kit. Unstimulated saliva samples will be self-collected by women after waking by passing a cotton swab for each test around the mouth in a circular movement for one minute. Swabs will be provided to women who consent to participate at recruitment and, once self-collected, they will be posted to a laboratory at La Trobe university for processing using a registered post addressed envelope provided by the research team. Samples will be taken by women at 20 and 36 weeks gestation.

Time and frequency domain heart rate variability will be measured on site by the research midwife following a scheduled pregnancy check-up (i.e., at recruitment and 36 weeks gestation). The research midwife will take women to a dimly lit, quiet room at the Royal Women’s Hospital for the assay (Room 10G, Chelsea House, 55 Flemington Road). Seated women will be fitted with an ECG recorder (Holter monitor), and asked to remain seated for an initial five minutes (familiarisation), then a further five minutes (rest). A five-minute cognitive test (to provoke a sympathetic autonomic response) will be conducted, then women will be asked to breathe in time to a metronome for five minutes at a rate of 20 breaths per minute (to initiate a parasympathetic response) and then to return to their normal (spontaneous) breathing pattern for five minutes. In total, this assay will take approximately 30 minutes to complete.

Differences in salivary cortisol and salivary alpha-amylase concentrations and time and frequency domain heart rate variability between groups will be assessed at both timepoints to determine if there are differential physiological stress responses by trial arm.
Intervention code [1] 318450 0
Prevention
Intervention code [2] 318451 0
Treatment: Other
Comparator / control treatment
Women randomised to usual care will have access to all the standard care options at the site, including hospital-based midwife care, team care, or shared care with a General Practitioner. They will not be eligible for any existing low risk caseload model as an option and this will be explicit in the recruitment process.
Control group
Active

Outcomes
Primary outcome [1] 324920 0
Premature birth – defined as birth before 37 completed weeks of gestation, obtained directly from the electronic medical record (EMR) after birth at all trial sites.
Timepoint [1] 324920 0
Obtained directly from medical record after birth.
Secondary outcome [1] 391244 0
Low birthweight – defined as birthweight < 2,500 grams,
Timepoint [1] 391244 0
Obtained directly from medical recordafter birth.
Secondary outcome [2] 391245 0
Admission to neonatal special or intensive care (NICU), obtained directly from the medical record after birth at all trial sites.
Timepoint [2] 391245 0
Obtained directly from medical record after birth.
Secondary outcome [3] 391246 0
Caesarean section birth.
Timepoint [3] 391246 0
Obtained directly from medical record after birth.
Secondary outcome [4] 391247 0
Satisfaction with care received during pregnancy as per Forster et al, BMC Pregnancy Childbirth 2016;16(28). 7-point Likert-type scale.
Timepoint [4] 391247 0
Measured by self-report at 3-month postpartum telephone interview.
Secondary outcome [5] 391248 0
Breastfeeding initiation.
Timepoint [5] 391248 0
Initiation data obtained from medical record after birth,.
Secondary outcome [6] 391249 0
Maternal psychological wellbeing, measured using the DASS-21 (Depression, Anxiety Stress) scale
Timepoint [6] 391249 0
Measured by self-report at 3-month postpartum telephone interview.
Secondary outcome [7] 391250 0
Health service use. Data will include use of Medicare-rebated (e.g. prescriptions, GP consultations) and non-Medicare-rebated health service use (e.g. routine and additional visits with MCHNs, hospital admissions, outpatient visits, ambulance use, private ultrasounds etc.) since birth. Medicare-rebated health service use will be obtained from Services Australia. Non-Medicare-rebated health service use will be collected via the 3-month postpartum questionnaire and hospital medical records. Resources used in intervention delivery (e.g., hours of midwife time) will be captured via midwife activity logs and estimates derived from care documented in the EMR. Midwife time will be valued according to state midwifery salary awards. Service use will be costed using existing unit costs sources (e.g. Medicare fee schedule, the Independent Hospital Pricing Authority reports (IHPA Costing report)). Model specific set up costs will be treated as a capital item with the total cost annuitized over time.
Timepoint [7] 391250 0
3-month interview using study-specific resource use questions; routinely collected Medicare data from Services Australia; midwife activity logs; electronic medical record.
Secondary outcome [8] 391251 0
Cost-effectiveness/cost utility: This will be a cost utility analysis, whereby Quality Adjusted Life Years will be used as the primary outcome for the economic evaluation. Costs will include cost to health service funders and out of pocket costs.
Timepoint [8] 391251 0
Measured at 3-month postpartum.
Secondary outcome [9] 391324 0
Birth experience as measured by McLachlan et al,, BJOG 2012;119(12):1483-92. 7-point likert-type scale.
Timepoint [9] 391324 0
Measured by self-report at 3-month postpartum telephone interview.
Secondary outcome [10] 391652 0
Care provider (midwives) satisfaction, Likert-type scales measured as per Newton, M.S., McLachlan, H.L., Willis, K.F. et al. Comparing satisfaction and burnout between caseload and standard care midwives: findings from two cross-sectional surveys conducted in Victoria, Australia. BMC Pregnancy Childbirth 14, 426 (2014). https://doi.org/10.1186/s12884-014-0426-7.
Timepoint [10] 391652 0
Baseline, 6 months post-implementation, 2 years post-implementation. If midwives leave the model during the study they will be asked to do an exit interview.
Secondary outcome [11] 391653 0
Stakeholder views of the model, future sustainability and scale up will be sought. Data will be sought via semi-structured interviews with key stakeholders including midwives working in the caseload model, managers of the caseload service, maternity services managers and medical staff. Interviews will explore the models 'fit' with existing services, interactions between service providers, and issues considered likely to negatively affect the sustainability of the model.
Timepoint [11] 391653 0
Interviews will commence once the model has been in place for 6 months with further interviews conducted at 2 years post-implementation..
Secondary outcome [12] 393587 0
Satisfaction with intrapartum care received as per Forster et al, BMC Pregnancy Childbirth 2016;16(28). 7-point Likert-type scale.
Timepoint [12] 393587 0
Measured by self-report at 3-month postpartum telephone interview.
Secondary outcome [13] 393588 0
Satisfaction with hospital postpartum care received as per Forster et al, BMC Pregnancy Childbirth 2016;16(28). 7-point Likert-type scale.
Timepoint [13] 393588 0
Measured by self-report at 3-month postpartum telephone interview.
Secondary outcome [14] 393589 0
Breastfeeding maintenance
Timepoint [14] 393589 0
'Any' breast milk feeding at 3 month telephone interview as per McLachlan et al, BMJ Open 2016;6(2)
Secondary outcome [15] 400453 0
Physiological stress response measuring salivary cortisol; salivary alpha-amylase; and time and frequency domain heart rate variability as per Landolt et al. Physiol Behav 2019; 199: 292-9. Time and frequency domain heart rate variability will be measured using an electrocardiogram (ECG) recorder (i.e., Holter monitor).

This is a composite secondary outcome.
Timepoint [15] 400453 0
Before 20' weeks gestation (at recruitment), and at 36 weeks' gestation.

Eligibility
Key inclusion criteria
Pregnant women less than 24 weeks gestation, booked as a public patient for maternity care at a study site, and considered to be socially vulnerable.

We will take a pragmatic approach to assessing eligibility for social vulnerability using available indicators from the literature that are able to be readily identified at the pregnancy booking visit from a clearly defined list, to ensure recruitment is consistent, and eligibility easily decided.

Women with any one (or more) of the following will be eligible: low income (on a government pension), less than 20 years of age (but not less than 14 years of age), unpartnered or living alone, current smoker, homeless, BMI less than 18.5, or greater than or equal to 35.
Minimum age
14 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
If the fetus has a known congenital anomaly likely to affect the primary outcome, or multiple pregnancy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to trial arm is concealed. Allocation will be via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation ratio will be 1:1 caseload midwifery care to usual care, with block sizes of variable length, distributed randomly. Blocks will be pre-assigned to strata.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be collected to meet CONSORT guidelines. We will check the baseline comparability of the groups, then the intervention group will be compared with the control group for all trial hypotheses using intention-to-treat analysis. The proportion of preterm infants will be compared for the primary outcome. Relative risks (RR) and 95% confidence intervals will be estimated. Regression analysis will adjust for all stratification variables, and for any differences in the key demographic characteristics at baseline. For other outcomes, binary outcomes will be estimated using RRs as per the primary outcome, and for continuous variables, comparison of means will be undertaken using t-tests where data are normally distributed, or medians compared using Mann-Whitney U tests otherwise.
Cost effectiveness/cost utility: A cost-consequences analysis will present the incremental costs of the intervention (costs of the intervention and health service use over the period of follow-up, minus costs accrued in the control arm) alongside a profile of all outcomes, then compare incremental costs per case of probable preterm births and other key outcomes avoided. We will adopt both a health services perspective and a social perspective. Future costs and benefits will be discounted at 3% with extensive sensitivity analysis to explore the robustness of the results. Probabilistic sensitivity analysis will be completed (using TreeAge software). The results will be presented on the cost-effectiveness plane and as cost-effectiveness acceptability curves and reported according to CHEERS guidelines. The main cost-effectiveness analysis will include a decision analytic (Markov) model to derive estimates of the long-term health costs and outcomes associated with premature birth building on similar work, but augmented to include information on health related quality of life for each of their synthetic states and updated to include recent data from Australian and international longitudinal databases.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/09/2022
Actual
6/09/2022
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
1832
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17338 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 17339 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 31066 0
3052 - Parkville
Recruitment postcode(s) [2] 31067 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 306273 0
Government body
Name [1] 306273 0
Australian Government, Department of Health
Country [1] 306273 0
Australia
Funding source category [2] 307728 0
University
Name [2] 307728 0
La Trobe University
Country [2] 307728 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 307193 0
None
Name [1] 307193 0
Address [1] 307193 0
Country [1] 307193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306480 0
St Vincent's Human Research Ethics Committee
Ethics committee address [1] 306480 0
Ethics committee country [1] 306480 0
Australia
Date submitted for ethics approval [1] 306480 0
16/02/2021
Approval date [1] 306480 0
16/06/2021
Ethics approval number [1] 306480 0
HREC 047/21

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

Contacts
Principal investigator
Name 104038 0
Prof Helen McLachlan
Address 104038 0
Judith Lumley Centre
George Singer Building
La Trobe University
Plenty Rd and Kingsbury Dr
Bundoora
VIC 3086
Country 104038 0
Australia
Phone 104038 0
+61 03 9479 5955
Fax 104038 0
Email 104038 0
m.cullinane@latrobe.edu.au
Contact person for public queries
Name 104039 0
Meabh Cullinane
Address 104039 0
Judith Lumley Centre
George Singer Building
La Trobe University
Plenty Rd and Kingsbury Dr
Bundoora
VIC 3086
Country 104039 0
Australia
Phone 104039 0
+61 03 9479 8832
Fax 104039 0
Email 104039 0
m.cullinane@latrobe.edu.au
Contact person for scientific queries
Name 104040 0
Meabh Cullinane
Address 104040 0
Judith Lumley Centre
George Singer Building
La Trobe University
Plenty Rd and Kingsbury Dr
Bundoora
VIC 3086
Country 104040 0
Australia
Phone 104040 0
+61 03 9479 8832
Fax 104040 0
Email 104040 0
m.cullinane@latrobe.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10404Ethical approval  m.cullinane@latrobe.edu.au
10405Study protocol  m.cullinane@latrobe.edu.au



Results publications and other study-related documents

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