Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000713998
Ethics application status
Approved
Date submitted
27/05/2020
Date registered
1/07/2020
Date last updated
18/10/2022
Date data sharing statement initially provided
1/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Antenatal models of care and the effect on breastfeeding rates after discharge
Scientific title
An evaluation of the effect of Midwifery Led Continuity of Care models vs. standard antenatal care on breastfeeding rates after discharge
Secondary ID [1] 301375 0
None
Universal Trial Number (UTN)
U1111-1252-6209
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 317625 0
Pregnancy care 317626 0
Condition category
Condition code
Reproductive Health and Childbirth 315707 315707 0 0
Antenatal care
Reproductive Health and Childbirth 315708 315708 0 0
Breast feeding
Reproductive Health and Childbirth 315896 315896 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure being studied is the type of antenatal care the woman has received for her pregnancy, specifically Midwifery Led Continuity of Care. This model of care is where the pregnant woman is cared for by the same Midwife or small group of Midwives during the antenatal, intrapartum and postnatal period. It is suggested that the relationship that is developed between the Midwife and pregnant woman may improve physical outcomes as well as satisfaction.

Midwifery Led Continuity of Care is associated with a range of positive maternal and neonatal outcomes. Midwives who work within this model of care are registered as Midwives under AHPRA (Australian Health Practitioner Regulation Agency) and work on call rather than rostered shifts. They practice within their own small teams of 4 Midwives, with each Midwife being allocated 4 pregnant women each month to care for. Within each Midwifery Led Continuity of Care team there is usually 1 experienced Midwife who acts as the team leader, 2 Midwives with over 5 years’ experience in all maternity areas (antenatal, intrapartum and postnatal), and 1 Graduate Midwife who is in her first year of practising as a Midwife.

Midwifery Led Continuity of Care has its philosophical foundations in the normalcy of pregnancy and birth, as well as recognising the importance of supporting and empowering the woman in decision making. This model of antenatal care is unique due to the continuity of care and this philosophy of woman centred care, and the relationship developed between Midwife and woman goes beyond patient and clinician.

This observational study will follow women who expressed an interest in Midwifery Led Continuity of Care. Due to the high demand for this model of care and limited spaces available, only some women will be accepted into this mode of antenatal care. Allocations to this model of care are by a “first come, first served” basis. Women who express an interest for this model of care and placed onto a spreadsheet in time order of when their expression of interest was received, and midwifery teams then offer places to women consecutively.

This study will follow both groups: women who are accepted into Midwifery Led Continuity of Care and those who were not (and therefore experience another model of care that is not Midwifery Led Continuity of Care). This model of care is currently practised within the study site, and therefore, women can access this model of pregnancy care regardless of their involvement in this study.

The exposure of Midwifery Led Continuity of Care is delivered over the pregnancy, from a “booking in” appointment at around 16 weeks gestation, through to approximately 6 weeks postpartum. These appointments are conducted in the hospital antenatal clinics, community antenatal clinics or in the woman’s home. This observational study aims to commence data collection from the time of this initial booking in appointment at 16 weeks gestations, to 4 months postpartum. This study will utilise a prospective observational study design with a cohort of pregnant women, with semi-quantitative survey instruments being used as the primary data collection tool.

Throughout the pregnancy, women are seen by their same assigned Midwife based on the following routine antenatal schedule:
16 weeks (phone appointment followed by face to face appointment on same day)
20-22 weeks (phone appointment)
24 weeks (phone appointment)
28-29 weeks (phone appointment followed by face to face appointment on same day)
34 weeks (phone appointment)
36 weeks (phone appointment followed by face to face appointment on same day)
40 weeks (phone appointment followed by face to face appointment on same day)
41 weeks (phone appointment followed by face to face appointment on same day)
Postnatal appointments are scheduled by midwives as clinically indicated.

Although the woman will attend these appointments with her midwife, this study does not follow up these women at each appointment, only at the questionnaire timepoints listed below.

These routine antenatal appointments consist of phone appointments, in which the clinician provides education related to breastfeeding, diet and exercise, and birth, as well as answering questions asked by the pregnant woman. Face to face appointments consist of a maternal and fetal wellbeing check (blood pressure, fundal height measurement, fetal heart rate), as well as reviewing and ordering any tests and investigations such a pathology or ultrasounds. Both face to face and phone call appointments are allocated half an hour for each.

Postnatal follow up appointments are usually based on 1 visit during the first week postnatally, and then based on clinical need for further in person follow ups. Due to the lack of structure in postnatal follow up, this data will be collected in the course of this study.
Personalised schedules of appointments may be implemented due to the clinician’s discretion, for example, additional appointments during the woman’s pregnancy due to high risk pregnancy.

This study will utilise questionnaires and interviews with pregnant women, and follows them until 4 months postpartum. 5 questionnaires will be sent to participants at time points:
S1 – Second Trimester Antenatal Questionnaire
- Sent to participants via email when they have expressed an interest in Midwifery Led Continuity of Care for their pregnancy care
S2 – Third Trimester Antenatal Questionnaire
- Sent to participants via email after their 36 week appointment
S3 – One Week Postpartum Questionnaire
- Sent to participants via email one week after they have delivered their baby
S4 – One Month Postpartum Questionnaire
- Sent to participants via email one month after they have delivered their baby
S5 – Four Months Postpartum Questionnaire
- Sent to participants via email four months after they have delivered their baby

These questionnaires have been created from validated tools from pre-existing studies (Dennis, 2003; Nommsen-Rivers & Dewey, 2009; Omar, Schiffman, & Bingham, 2001; Sword et al., 2015), individual questions from previously performed questionnaires and hospital specific questions to assess key points related to RBWH models of pregnancy care.

Interviews with some women will also be conducted at time points to align with the Third Trimester Antenatal Questionnaire (S2) and One Month Postpartum Questionnaire (S4). Women can indicate their interest in being part of these interviews when consenting to the study, and these interviews will be offered in a mode that suits the mother (in person, via telephone or zoom/Microsoft teams). Numbers of women to be interviewed will be guided by the concept of saturation and continued until no new or significant information is elicited through these interviews. Themes to be discussed during these interviews include:
- Plans surrounding infant feeding and reasons for these intentions
- Motivations to breastfeed
- Familiarity of breastfeeding within the individual’s world
- Relationship between antenatal caregiver and individual woman
- Antenatal expectations of infant feeding and postpartum realities
- Barriers to breastfeeding
- Person experiences of infant feeding choices
Intervention code [1] 317673 0
Not applicable
Comparator / control treatment

The comparator group will be women who expressed an interested in Midwifery Led Continuity of Care, however were not accepted into this model due to limited places within these teams. Once women express an interest in this model, they are offered a place within the Midwifery Led Continuity Care teams on the basis of “first come, first serve.” Therefore, approximately two thirds of women who request this model are unable to be placed within these teams. These women are notified they are not successful in receiving a place and send an appointment for their routine antenatal care “booking in” appointment, and these women will therefore experience another model of pregnancy care that is not Midwifery Led Continuity of Care. These models of care include routine hospital antenatal care, GP Shared Care and Obstetric Led Care. Women in these models of care experience care by a range of clinicians including Obstetricians, Midwives, and General Practitioners.

GP Shared care is where the woman attends the majority of her antenatal care appointments at with a community GP, with only three appointments attended at the hospital with a midwife. The hospital midwives that these women see are rostered to shifts, and therefore, it is very likely they will see a different Midwife at each hospital visit. Obstetric Led Care is implemented when a woman is considered to be a high risk pregnancy due to pre-existing medical conditions or conditions that occur during her pregnancy. In this model, the woman experiences antenatal care at the hospital and mostly see Obstetricians, with two midwifery appointments during her pregnancy. Again, the Obstetricians and Midwives are rostered, and for that reason it is very likely the woman will see a different clinician at each visit she attends.

Within these models, there is not a planned element of continuity of care, meaning that although the woman may coincidentally see the same clinician, this is unintentional and likely to not occur. Pregnant women will be seen by whoever is rostered on shift the day that she attends for her antenatal appointments or presents in labour. Although women may see the same GP for their pregnancy, it is theorised that although GP's are integral components of antenatal care, they may not provide the same breastfeeding education and support as midwives may during the woman's pregnancy and postpartum period.

Women who experience GP Shared Care or Obstetric Led Care are seen during their pregnancy based on the following antenatal schedule:
16 weeks (phone appointment with hospital Midwife)
20-22 weeks (face to face appointment with GP or Obstetrician)
24 weeks (phone appointment or face to face appointment with GP or hospital Midwife)
28-29 weeks (face to face appointment with GP, Obstetrician or hospital Midwife)
34 weeks (phone appointment or face to face appointment with GP, Obstetrician or hospital Midwife)
36 weeks (face to face appointment with Obstetrician or hospital Midwife)
40 weeks (face to face appointment with Obstetrician or hospital Midwife)
41 weeks (face to face appointment with Obstetrician or hospital Midwife)

Importantly, although there is Midwifery input within these care models, this is with a rostered hospital Midwife and therefore it is not possible to maintain continuity of care.
Postnatal follow up is usually performed by face to face or phone consultation with the woman's GP, at 1 week postpartum and 6 weeks postpartum.

Women in these care models will be sent the questionnaires at the same time points as previously listed, and although will attend antenatal care appointments throughout their pregnancy, will not be seen by the study team at these routine appointments.
Control group
Active

Outcomes
Primary outcome [1] 323933 0
Proportion of participants who receive Midwifery Led Continuity of Care compared with those who did not receive Midwifery Led Continuity of Care who are breastfeeding. This will be assessed by reviewing breastfeeding status at questionnaire time points (One Week Postpartum Questionnaire, One Month Postpartum Questionnaire, and Four Months Postpartum Questionnaire). Assessment of current infant feeding status will be collected using questions designed for this study which assess breastfeeding status (breastfeeding exclusively, breastfeeding with occasional other fluids, formula feding only, or combination of breast and formula feeding). These questions have been piloted with health professionals and antenatal and postnatal women to ensure that they are easily understood and language used surrounding breastfeeding and formula feeding is acceptable. Hospital records will be reviewed to determine model of care received during the woman’s pregnancy to compare different models of care and their breastfeeding outcomes.
Timepoint [1] 323933 0
1 week postpartum, 1 month postpartum and 4 months postpartum (primary timepoint)
Primary outcome [2] 323934 0
Proportion of participants who receive Midwifery Led Continuity of Care compared with those who did not receive Midwifery Led Continuity of Care who are no longer breastfeeding (artificially feeding/formula feeding only). This will be assessed by reviewing breastfeeding status at questionnaire time points (One Week Postpartum Questionnaire, One Month Postpartum Questionnaire, and Four Months Postpartum Questionnaire). Assessment of current infant feeding status will be collected using questions designed for this study which assess breastfeeding status (breastfeeding exclusively, breastfeeding with occasional other fluids, formula feding only, or combination of breast and formula feeding). Data will also be collected through questions designed for this study which assess when formula feeding was initiated and frequency of formula feeds being given to the baby. These questions have been piloted with health professionals and antenatal and postnatal women to ensure that they are easily understood and language used surrounding breastfeeding and formula feeding is acceptable. Hospital records will be reviewed to determine model of care received during the woman’s pregnancy to compare different models of care and their breastfeeding outcomes.
Timepoint [2] 323934 0
1 week postpartum, 1 month postpartum and 4 months postpartum (primary timepoint)
Primary outcome [3] 323935 0
Proportion of participants who receive Midwifery Led Continuity of Care compared with those who did not receive Midwifery Led Continuity of Care who met their indicated antenatal feeding intentions (breastfeeding exclusivity or duration). Antenatal feeding intentions will be collected during the Third Trimester Questionnaire, and compared with breastfeeding status at questionnaire time points One Week Postpartum Questionnaire, One Month Postpartum Questionnaire, and Four Months Postpartum Questionnaire. Antenatal feeding intentions will be assessed by using a validated tool, the "Infant Feeding Intentions Scale" (Nommsen-Rivers & Dewey, 2009). Breastfeeding status will be assessed using questions designed for this study (breastfeeding exclusively, breastfeeding with occasional other fluids, formula feding only, or combination of breast and formula feeding). These questions have been piloted with health professionals and antenatal and postnatal women to ensure that they are easily understood and language used surrounding breastfeeding and formula feeding is acceptable. Hospital records will be reviewed to determine model of care received during the woman’s pregnancy to compare different models of care and their breastfeeding outcomes.

Timepoint [3] 323935 0
1 week postpartum, 1 month postpartum and 4 months postpartum (primary timepoint)
Secondary outcome [1] 383371 0
Quality of antenatal care based on the validated tool, the Quality of Prenatal Care Questionnaire (Heaman et al., 2014).
Timepoint [1] 383371 0
36 weeks gestation (Third Trimester Questionnaire)
Secondary outcome [2] 383372 0
Rates of hospital readmission for infant after postpartum hospital discharge. This outcome will be collected through review of medical records, and will also be collected through the One Week Postpartum Questionnaire using questions designed for this study which assess number of hospital presentations and admissions within the first week postpartum. These questions have been piloted with health professionals and antenatal and postnatal women to ensure that they are easily understood and language is appropriate.
Timepoint [2] 383372 0
1 week postpartum
Secondary outcome [3] 384274 0
Analysis of the woman's experiences of the relationships that developed between women and their antenatal carer within Midwifery Led Continuity of Care models, and women and their antenatal carer who were not within Midwifery Led Continuity of Care models.
Timepoint [3] 384274 0
4 weeks postpartum one-on-one open ended interview, maximum of 1 hour in length. Interviews will be offered to postnatal mothers to occur either in person (face to face) or via Microsoft Teams software, at a time convenient to the woman. Interviews will be audio recorded and transcribed.
Secondary outcome [4] 384275 0
Women's antenatal motivations regarding infant feeding (and reasons surrounding this motivation) and the postpartum realities and barriers of infant feeding.
Timepoint [4] 384275 0
One-on-one open ended interviews conducted during the third trimester of pregnancy and at 4 weeks postpartum. Each interview will be a maximum of 1 hour in length. Interviews will be offered to pregnant and postnatal women to occur either in person (face to face) or via Microsoft Teams software, at a time convenient to the woman. Interviews will be audio recorded and transcribed.

Eligibility
Key inclusion criteria
• Women who have expressed an interest in and been considered for receiving antenatal care by midwifery continuity of care teams Aurora/Aster or Birth Centre
• Women aged 18 years and over
• Women with a singleton pregnancy
• Women who have a command of written English to enable completion of questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women who are pregnant with a fetus that has a known significant abnormality/who delivered a neonate with significant abnormalities

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
There is limited data on this topic to base a sample size calculation on for the primary outcome of interest. Based on our team’s previous work, the estimated population prevalence of fully breastfeeding at 4 months postpartum is 60%. To detect a clinically significant difference of 10% at 4 months postpartum with 90% power and 95% confidence level, we will need to recruit 670 women accounting for a 35% drop out rate previously experienced from team member’s studies within the maternity population.

The initial analysis will examine baseline characteristics of all women and which model of care they received. Key demographic characteristics such as education and socioeconomic status will be collected to control for potential selection bias into each model of care, as well as birth data collected that may be confounding factors for a reduced length of breastfeeding.

Data will be analysed using univariate statistics. Descriptive statistics will be calculated for all variables. Continuous, normally distributed variables will be described as mean, range and standard deviations, non-normally distributed variables will be described using median and interquartile range values. Categorical data will be described using frequencies and percentages.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/07/2020
Actual
9/07/2020
Date of last participant enrolment
Anticipated
27/10/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
670
Accrual to date
303
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16767 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 30390 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 305814 0
Hospital
Name [1] 305814 0
RBWH & RBWH Foundation Scholarship
Country [1] 305814 0
Australia
Primary sponsor type
Individual
Name
Emma Shipton
Address
C/O Perinatal Research Centre
Level 6, Ned Hanlon Building
Royal Brisbane and Women’s Hospital
Butterfield St, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 306273 0
None
Name [1] 306273 0
Address [1] 306273 0
Country [1] 306273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306083 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 306083 0
Ethics committee country [1] 306083 0
Australia
Date submitted for ethics approval [1] 306083 0
26/10/2019
Approval date [1] 306083 0
04/12/2019
Ethics approval number [1] 306083 0
HREC/2019/QRBW/48710

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

Contacts
Principal investigator
Name 102642 0
Ms Emma Shipton
Address 102642 0
C/O Perinatal Research Centre
Level 6, Ned Hanlon Building
Butterfield St, Herston QLD 4029
Country 102642 0
Australia
Phone 102642 0
+61 7 3646 3075
Fax 102642 0
Email 102642 0
e.shipton@uqconnect.edu.au
Contact person for public queries
Name 102643 0
Emma Shipton
Address 102643 0
C/O Perinatal Research Centre
Level 6, Ned Hanlon Building
Butterfield St, Herston QLD 4029
Country 102643 0
Australia
Phone 102643 0
+61 7 3646 3075
Fax 102643 0
Email 102643 0
e.shipton@uqconnect.edu.au
Contact person for scientific queries
Name 102644 0
Emma Shipton
Address 102644 0
C/O Perinatal Research Centre
Level 6, Ned Hanlon Building
Butterfield St, Herston QLD 4029
Country 102644 0
Australia
Phone 102644 0
+61 7 3646 3075
Fax 102644 0
Email 102644 0
e.shipton@uqconnect.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified information about participants collecting during the study including demographics, as well as clinical and breastfeeding specific outcomes
When will data be available (start and end dates)?
Data will be available following publication, with no end date determined
Available to whom?
Data will be available to researchers on a case-by-case basis at the discretion of the Principal Investigator
Available for what types of analyses?
Data will be available for future IPD meta-analyses related to the topic of this study
How or where can data be obtained?
Access to data will be given on a case-by-case basis by the Principal Investigator who can be contacted by email: e.shipton@uqconnect.edu.au


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.