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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
Scientific title
PECS – [Perinatal Education Care Support] group model of multidisciplinary maternity care: a feasibility study
Secondary ID [1] 301417 0
nil
Universal Trial Number (UTN)
Trial acronym
PECS
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Mental health 317949 0
Childbirth 317950 0
Condition category
Condition code
Reproductive Health and Childbirth 315980 315980 0 0
Normal pregnancy
Reproductive Health and Childbirth 315981 315981 0 0
Antenatal care
Reproductive Health and Childbirth 315982 315982 0 0
Childbirth and postnatal care
Mental Health 316353 316353 0 0
Depression
Mental Health 316354 316354 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 317728 0
Prevention
Intervention code [2] 317729 0
Early detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 323979 0
Depressive symptoms, Edinburgh Postnatal Depression Scale, EPDS
Timepoint [1] 323979 0
Baseline (approx. 31-weeks gestation)
38 weeks gestation
2 - 4 weeks postnatal
6 - 8 weeks postnatal
Follow up: 12 - 16 weeks postnatal
Primary outcome [2] 323980 0
Anxiety symptoms, Depression Anxiety Stress Scales (DASS)
Timepoint [2] 323980 0
Baseline (approx. 31-weeks gestation)
38 weeks gestation
2 - 4 weeks postnatal
6 - 8 weeks postnatal
Follow up: 12 - 16 weeks postnatal
Secondary outcome [1] 383954 0
Smoking cessation: determined by 7 consecutive days without cigarettes.
Timepoint [1] 383954 0
2 - 4 weeks postnatal, as indicated by the women's antenatal hospital medical records.
Secondary outcome [2] 383955 0
Gestational age at birth = </>37 weeks
Timepoint [2] 383955 0
2 - 4 weeks postnatal, as indicated by the women's hospital medical records.
Secondary outcome [3] 383956 0
Mode of delivery = vaginal / caesarean
Timepoint [3] 383956 0
2 - 4 weeks postnatal, as indicated by the women's hospital medical records.
Secondary outcome [4] 383957 0
Weight = >10th percentile
Timepoint [4] 383957 0
2 - 4 weeks postnatal, as indicated in the baby hospital medical records.
Secondary outcome [5] 383958 0
Apgar score = 1-min; 5-min
Timepoint [5] 383958 0
2 - 4 weeks postnatal, as indicated in the baby hospital medical records
Secondary outcome [6] 383959 0
Jaundice
Timepoint [6] 383959 0
2 - 4 weeks postnatal, as indicated in the baby hospital medical records.
Secondary outcome [7] 383960 0
Days mother spends on postnatal ward = <24-hours; 1 – 2 days; >3-days
Timepoint [7] 383960 0
2 - 4 weeks postnatal, as indicated in the women's hospital medical records.
Secondary outcome [8] 383961 0
Breastfeeding initiation
Timepoint [8] 383961 0
2 - 4 weeks postnatal, as indicated in the women's hospital medical records
Secondary outcome [9] 383962 0
Breastfeeding duration
Timepoint [9] 383962 0
3 month follow-up, as indicated in the participant on-one-one interview, conducted via teleconference (Webex).
Secondary outcome [10] 383965 0
Feasibility, acceptability and satisfaction with the group-based model of care and education
Timepoint [10] 383965 0
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).
Secondary outcome [11] 384871 0
Days baby spends on postnatal ward = <24-hours; 1 – 2 days; >3-days
Timepoint [11] 384871 0
2 - 4 weeks postnatal, as indicated in the baby's hospital medical records

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
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
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

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/08/2020
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
128
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16818 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 30441 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 305856 0
University
Name [1] 305856 0
RFA Building Healthy Communities - La Trobe University
Country [1] 305856 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 306304 0
Hospital
Name [1] 306304 0
Pakenham Health Centre Pregnancy Clinic Monash Health
Address [1] 306304 0
Henty Way, Pakenham VIC 3810
Country [1] 306304 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306116 0
Monash Health
Ethics committee address [1] 306116 0
Ethics committee country [1] 306116 0
Australia
Date submitted for ethics approval [1] 306116 0
10/01/2020
Approval date [1] 306116 0
22/05/2020
Ethics approval number [1] 306116 0
RES-20-0000157A-59849
Ethics committee name [2] 306119 0
La Trobe University
Ethics committee address [2] 306119 0
Ethics committee country [2] 306119 0
Australia
Date submitted for ethics approval [2] 306119 0
22/05/2020
Approval date [2] 306119 0
25/05/2020
Ethics approval number [2] 306119 0
RES-20-0000157A-59849

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

Contacts
Principal investigator
Name 102766 0
Dr Melissa Buultjens
Address 102766 0
La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country 102766 0
Australia
Phone 102766 0
+61 03 9479 6502
Fax 102766 0
n/a
Email 102766 0
m.buultjens@latrobe.edu.au
Contact person for public queries
Name 102767 0
Melissa Buultjens
Address 102767 0
La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country 102767 0
Australia
Phone 102767 0
+61 03 9479 6502
Fax 102767 0
n/a
Email 102767 0
m.buultjens@latrobe.edu.au
Contact person for scientific queries
Name 102768 0
Melissa Buultjens
Address 102768 0
La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country 102768 0
Australia
Phone 102768 0
+61 03 9479 6502
Fax 102768 0
n/a
Email 102768 0
m.buultjens@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
Consent not obtained


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.