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Trial registered on ANZCTR
Registration number
ACTRN12620000833965
Ethics application status
Approved
Date submitted
1/06/2020
Date registered
21/08/2020
Date last updated
21/08/2020
Date data sharing statement initially provided
21/08/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
A multidisciplinary group model of maternity care: a feasibility study
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Scientific title
PECS – [Perinatal Education Care Support] group model of multidisciplinary maternity care: a feasibility study
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Secondary ID [1]
301417
0
nil
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Universal Trial Number (UTN)
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Trial acronym
PECS
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Linked study record
n/a
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Health condition
Health condition(s) or problem(s) studied:
Mental health
317949
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Childbirth
317950
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Condition category
Condition code
Reproductive Health and Childbirth
315980
315980
0
0
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Normal pregnancy
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Reproductive Health and Childbirth
315981
315981
0
0
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Antenatal care
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Reproductive Health and Childbirth
315982
315982
0
0
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Childbirth and postnatal care
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Mental Health
316353
316353
0
0
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Depression
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Mental Health
316354
316354
0
0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This feasibility study will investigate the acceptability, demand, practicality and efficacy of a group-based multidisciplinary model of maternity care among a sample of pregnant women experiencing their first pregnancy. Additionally, we will examine whether a group model of care across the perinatal period can influence physical and psychological health of women. This will be achieved by comparing two groups, i.e., women involved in the group intervention with women receiving standard care. Women will be offered a group model of care and education at their booking-in appointment, thus participants have choice and to whether they engage in the group-based intervention, or standard care.
The intervention is a group-based model of perinatal care that will consist of education and support provided by a team of allied health professionals, together with medical care from midwives. The education and support are provided by a multidisciplinary team of perinatal health professionals, including, a women’s health physiotherapist, a psychologist, dietitian, yoga instructor and a lactation consultant, in addition to the hospital midwives. The group care model will be offered to women who meet the inclusion criteria (as identified by the outpatient’s manager) at their booking-in appointment.
Women involved in the intervention will receive an individual face-to-face booking-in appointment and another individual health visit with the doctor. From this point, the women’s clinical appointments are completed via telehealth virtual visits. At 31-weeks, their clinical visits are in a group online format, combining education. The groups will consist of 8 – 12 women and will run at 31, 34, 36 and 38 weeks and will be 90 minutes in length. There are also four group postnatal education sessions, conducted online. These are held weekly for 90 minutes, beginning at 2 – 4 weeks after birth.
The modules are facilitated by key health professionals for open engagement and discussion of topics. The antenatal group-based online education sessions will be provided by a multidisciplinary team, as outlined above. Topics include (but not limited to): important nutrients for the growth and development of a growing fetus, important nutrients for skin integrity (birth), nutrients for breastfeeding. Strategies to deal with common pregnancy discomforts and exercise during pregnancy. Expectations of birth and the changing roles and relationships, challenges of pregnancy, birth and early parenthood. Techniques to manage pain during labour and birth. Breastfeeding attachments techniques and tips for breastfeeding success.
In the postnatal group-based online education sessions, topics covered will include: a birth debrief, recovery from birth, e.g. when to resume exercise and associated mother-baby bonding activities, e.g. mother-baby yoga.
Alongside the structured clinical care and education, women in the group intervention will have access to an online portal where they will be able to access timely information relevant to each stage of pregnancy and early parenthood. The online portal will be able to capture individual analytics and any women who are not able to make any scheduled online session, will be followed up.
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Intervention code [1]
317728
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Prevention
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Intervention code [2]
317729
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Early detection / Screening
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Comparator / control treatment
The comparison group will receive standard care consisting routine antenatal care (Standard Midwifery Care (SMC)), intrapartum, and postnatal care with no special intervention applied. This includes optional antenatal classes, which address the birth and early postnatal period. The comparison group (i.e., women recruited to the standard model of care) will be recruited at the booking-in appointment and presented alongside the full suite of antenatal care options. The comparison group will be followed up at the same timepoints as described for the intervention group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Depressive symptoms, Edinburgh Postnatal Depression Scale, EPDS
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Assessment method [1]
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Timepoint [1]
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Baseline (approx. 31-weeks gestation)
38 weeks gestation
2 - 4 weeks postnatal
6 - 8 weeks postnatal
Follow up: 12 - 16 weeks postnatal
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Primary outcome [2]
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Anxiety symptoms, Depression Anxiety Stress Scales (DASS)
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Assessment method [2]
323980
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Timepoint [2]
323980
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Baseline (approx. 31-weeks gestation)
38 weeks gestation
2 - 4 weeks postnatal
6 - 8 weeks postnatal
Follow up: 12 - 16 weeks postnatal
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Secondary outcome [1]
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Smoking cessation: determined by 7 consecutive days without cigarettes.
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Assessment method [1]
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Timepoint [1]
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2 - 4 weeks postnatal, as indicated by the women's antenatal hospital medical records.
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Secondary outcome [2]
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Gestational age at birth = </>37 weeks
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Assessment method [2]
383955
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Timepoint [2]
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2 - 4 weeks postnatal, as indicated by the women's hospital medical records.
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Secondary outcome [3]
383956
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Mode of delivery = vaginal / caesarean
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Assessment method [3]
383956
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Timepoint [3]
383956
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2 - 4 weeks postnatal, as indicated by the women's hospital medical records.
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Secondary outcome [4]
383957
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Weight = >10th percentile
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Assessment method [4]
383957
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Timepoint [4]
383957
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2 - 4 weeks postnatal, as indicated in the baby hospital medical records.
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Secondary outcome [5]
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Apgar score = 1-min; 5-min
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Assessment method [5]
383958
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Timepoint [5]
383958
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2 - 4 weeks postnatal, as indicated in the baby hospital medical records
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Secondary outcome [6]
383959
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Jaundice
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Assessment method [6]
383959
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Timepoint [6]
383959
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2 - 4 weeks postnatal, as indicated in the baby hospital medical records.
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Secondary outcome [7]
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Days mother spends on postnatal ward = <24-hours; 1 – 2 days; >3-days
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Assessment method [7]
383960
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Timepoint [7]
383960
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2 - 4 weeks postnatal, as indicated in the women's hospital medical records.
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Secondary outcome [8]
383961
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Breastfeeding initiation
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Assessment method [8]
383961
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Timepoint [8]
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2 - 4 weeks postnatal, as indicated in the women's hospital medical records
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Secondary outcome [9]
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Breastfeeding duration
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Assessment method [9]
383962
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Timepoint [9]
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3 month follow-up, as indicated in the participant on-one-one interview, conducted via teleconference (Webex).
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Secondary outcome [10]
383965
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Feasibility, acceptability and satisfaction with the group-based model of care and education
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Assessment method [10]
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Timepoint [10]
383965
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At follow up (approx. 3 months postnatal). In-depth one-on one interviews with women who participated in the group-based intervention and midwives involved in delivering the clinical care component of the intervention. Interviews conducted via teleconference (Webex).
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Secondary outcome [11]
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Days baby spends on postnatal ward = <24-hours; 1 – 2 days; >3-days
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Assessment method [11]
384871
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Timepoint [11]
384871
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2 - 4 weeks postnatal, as indicated in the baby's hospital medical records
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Eligibility
Key inclusion criteria
• First pregnancy
• Aged: >/= 18 years
• 12-weeks of gestation evidenced by dating scan
• Deemed medically low-risk by Obstetrician by 28-weeks
• Must be able to read, understand and speak English
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Deemed medically high-risk and unable to participate in group care due to medical intervention, as per assessment and recommendation by obstetrician at 28-weeks and beyond
• Women who score 1, 2, or 3 on Item 10 on the EPDS at the beginning of the intervention / standard care, and anytime thereafter
• Women who score in the severe range on the DASS
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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)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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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
This project is an interventional research study, comparing two non-randomised groups of women, i.e., group care (forming the intervention group) vs. standard care with biopsychosocial assessment (forming the comparison group). Groups are non-randomised to allow women to choose their model of maternity care and thus measure feasibility i.e., demand and uptake.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
All statistical analyses will be performed using SPSS 19.0. Descriptive statistics comprising frequencies, means, standard deviations and percentages will be computed. Inferential statistics will include: Levene's test of homogeneity of variance, the independent-samples t-test of means for continuous variables, and Fisher's exact tests for categorical variables.
To assess the effect of the intervention (i.e., group model of care) over time, repeated measures of ANOVA will be conducted. The between groups effects over time will be evaluated. Particular analysis of end-points will be measured to compare the size of the intervention effect; that is, the magnitude of the difference between mean scores of the intervention versus the comparison group.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
12/08/2020
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Date of last participant enrolment
Anticipated
26/02/2021
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Actual
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Date of last data collection
Anticipated
31/03/2021
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Actual
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Sample size
Target
128
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Accrual to date
30
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
16818
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment postcode(s) [1]
30441
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
305856
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University
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Name [1]
305856
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RFA Building Healthy Communities - La Trobe University
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Address [1]
305856
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Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
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Country [1]
305856
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
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Country
Australia
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Secondary sponsor category [1]
306304
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Hospital
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Name [1]
306304
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Pakenham Health Centre Pregnancy Clinic Monash Health
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Address [1]
306304
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Henty Way, Pakenham VIC 3810
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Country [1]
306304
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306116
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Monash Health
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Ethics committee address [1]
306116
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246 Clayton Rd, Clayton VIC 3168
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Ethics committee country [1]
306116
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Australia
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Date submitted for ethics approval [1]
306116
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10/01/2020
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Approval date [1]
306116
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22/05/2020
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Ethics approval number [1]
306116
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RES-20-0000157A-59849
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Ethics committee name [2]
306119
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La Trobe University
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Ethics committee address [2]
306119
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Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
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Ethics committee country [2]
306119
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Australia
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Date submitted for ethics approval [2]
306119
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22/05/2020
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Approval date [2]
306119
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25/05/2020
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Ethics approval number [2]
306119
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RES-20-0000157A-59849
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Summary
Brief summary
Antenatal care traditionally involves a schedule of one-to-one visits with a care provider, however an emerging way of providing antenatal care involves the use of a group model, which already shows promise in optimising birth outcomes such as preterm birth and low birth weight. Current maternity models such as shared-care or midwife-led care attempt to provide a women-centred philosophy, incorporating continuity of care. Despite best efforts there are shortcomings in antenatal service delivery, including a lack of timely information and professional and emotional support. The evidence largely indicates that women feel unprepared for the psychological, social, and physical challenges, creating risk for mental health problems during a time of unparalleled change.
Acquisition of knowledge is important in influencing maternal behaviour and birth outcomes. While the etiology of birth outcomes is complex, psychosocial factors including stress, anxiety, depression, and social support are critical factors that can increase the risk of medical complications and further increases the risk of children having a wide range of adverse outcomes. While antenatal care has traditionally involved a schedule of one-to-one visits, group models of care are emerging as a way of delivering clinical health services to pregnant women, integrating the usual pregnancy health assessment with tailored group education and peer support, thus incorporating broader psychosocial aspects. In promoting health and wellbeing during a time where reconfiguration of service delivery is required. The primary purpose of the current research is to examine a group model of multidisciplinary care. It is hypothesized that a group model comprising care and education provided in-part via telehealth digital technologies for pregnant women that extends into the postpartum period, will provide greater access to care and education, improving perinatal physical and psychosocial health outcomes for mother and infant, in comparison to women receiving standard maternity care.
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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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Dr Melissa Buultjens
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Address
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La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
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Country
102766
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Australia
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Phone
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+61 03 9479 6502
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Fax
102766
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n/a
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Email
102766
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[email protected]
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Contact person for public queries
Name
102767
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Dr Melissa Buultjens
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Address
102767
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La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
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Country
102767
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Australia
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Phone
102767
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+61 03 9479 6502
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Fax
102767
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n/a
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Email
102767
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[email protected]
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Contact person for scientific queries
Name
102768
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Dr Melissa Buultjens
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Address
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La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
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Country
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Australia
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Phone
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+61 03 9479 6502
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Fax
102768
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n/a
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Email
102768
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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
Consent not obtained
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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.
Download to PDF