Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000915752
Ethics application status
Approved
Date submitted
15/06/2022
Date registered
27/06/2022
Date last updated
22/01/2024
Date data sharing statement initially provided
27/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the feasibility of conducting a randomised controlled trial (RCT) comparing standard (face-to-face) antenatal care with a combination of video health and face-to-face visits: a pilot RCT to inform a larger adequately powered study.
Scientific title
Testing the feasibility of conducting a randomised controlled trial (RCT) comparing standard (face-to-face) antenatal care with a combination of video health and face-to-face visits: a pilot RCT to inform a larger adequately powered study.
Secondary ID [1] 307324 0
Nil known
Universal Trial Number (UTN)
Trial acronym
THE TULIP STUDY: Telehealth Use In Pregnancy – a pilot randomised controlled trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 326610 0
Antenatal care 326611 0
Condition category
Condition code
Reproductive Health and Childbirth 323854 323854 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will have two arms – the intervention: combined video-based telehealth and face-to-face pregnancy care; and the control: all face-to-face pregnancy care.

For each trial arm the schedule for pregnancy visits will follow the routine schedule for each study site, the location for the visit will change depending on which trial arm the participant is allocated. The following is draft of the expected schedule of visits for the intervention:

Intervention: Combined video-based telehealth and face-to-face pregnancy care
20-22 weeks gestation: Midwife appointment telehealth: Midwife reviews and discusses patients’ morphology ultrasound, if occurs prior to this appointment, organises further ultrasounds if required, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests if occurred prior to this appointment and organises further testing/management if required. Midwife organises gestational diabetes testing and any other testing appropriate to risk factors/indication prior to next appointment. Midwife records recent blood pressure (either undertaken in community or at home) and acts upon if required. Duration 20 minutes
28 weeks gestation: Midwife appointment face-to-face: Midwife reviews and discusses patients’ morphology ultrasound if occurred post last appointment, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If the woman is a negative blood group, Anti-D is administered. Duration 20 minutes
31-32 weeks gestation: Midwife appointment telehealth: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife records recent blood pressure (either undertaken in community or at home) and acts upon if required. Duration 20 minutes
34 weeks gestation: Midwife appointment telehealth*: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife records recent blood pressure (either undertaken in community or at home) and acts upon if required. Duration 20 minutes
36 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If woman consents, midwife organises Group B Streptococcus testing. Duration 20 minutes.
38 weeks gestation: Midwife appointment telehealth: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife records recent blood pressure (either undertaken in community or at home) and acts upon if required. Duration 20 minutes
40 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes.
41 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Midwife organises follow up for induction of labour planning as per hospital guidelines. Duration 20 minutes.
*Where the woman is a negative blood group, this appointment will be made face-to-face to accommodate anti-D administration

As telehealth visits will be conducted via video, routine physically examinations such as fundal height (measurement to monitor growth of the fetus), abdominal palpation for fetal position, auscultation of the fetal heart and blood pressure measurement will not be able to be undertaken during the appointment. Potential alternative arrangements for conducting these physical examinations (e.g. measurement of blood pressure at pharmacy or GP prior to telehealth appointment) will be guided by the processes currently in place at each study site.

Adherence to the intervention will be assessed by auditing all participants electronic medical record or hospital administration record (site dependent) to assess if appointment was conducted on the above schedule and location (e.g., telehealth/face-to-face) as planned.
Intervention code [1] 323766 0
Prevention
Comparator / control treatment
Control: All face-to-face pregnancy care
20-22 weeks gestation: Midwife appointment face-to-face: Midwife reviews and discusses patients’ morphology ultrasound, if occurs prior to this appointment, organises further ultrasounds if required, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests if occurred prior to this appointment and organises further testing/management if required. Midwife organises gestational diabetes testing and any other testing appropriate to risk factors/indication prior to next appointment. Midwife measures blood pressure and acts upon any abnormal findings. Duration 20 minutes
28 weeks gestation: Midwife appointment face-to-face: Midwife reviews and discusses patients’ morphology ultrasound if occurred post last appointment, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If the woman is a negative blood group, Anti-D is administered. Duration 20 minutes
31-32 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes
34 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If the woman is a negative blood group, Anti-D is administered. Duration 20 minutes
36 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If woman consents, midwife organises Group B Streptococcus testing. Duration 20 minutes.
38 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes
40 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes
41 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Midwife organises follow up for induction of labour planning as per hospital guidelines. Duration 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 331670 0
Composite outcome – proportion of participants who experience of any one (or more) of the adverse neonatal or maternal outcomes:
• neonatal – preterm birth, small for gestational age after 37 weeks, fetal growth restriction after 37 weeks, macrosomia, term admission to Special Care Nursery/Neonatal Intensive Care, fetal death in utero, stillbirth, APGAR score less than 7 at five minutes post birth;
• maternal– eclampsia, pre-eclampsia with severe features (e.g., HELLP syndrome), uncontrolled diabetes, Intensive Care Unit/High Dependency Unit admission, death.
This will be measured by assessing routinely collected clinical data from electronic/medical records
Timepoint [1] 331670 0
At three months post birth of last baby in study
Secondary outcome [1] 410704 0
To explore what percentage of the visits in both trial arms were conducted in the ‘place’ planned assessed by accessing patient electronic or paper medical records
Timepoint [1] 410704 0
Post birth of baby
Secondary outcome [2] 410711 0
Explore if the technology worked as planned assessed using questions specifically developed for this study
Timepoint [2] 410711 0
Assessed two months post birth of baby at telephone based survey
Secondary outcome [3] 410712 0
Investigate women’s willingness to be randomised for a trial exploring telehealth for pregnancy care and the potential uptake of participation in a larger trial. Measured by collecting data during the recruitment period of number of eligible women and number of women who consented to be part of the study
Timepoint [3] 410712 0
Calculated post recruitment of all study participants (approximately two months post first randomisation)
Secondary outcome [4] 410713 0
Explore if there is any obvious evidence of harm in providing telehealth for pregnancy care assessed by accessing patient electronic or paper medical records
Timepoint [4] 410713 0
Measured at birth
Secondary outcome [5] 410714 0
Explore potential primary clinical outcome/s for the larger randomisation control trial assessed by accessing patient electronic or paper medical records and discussing clinical outcomes with clinical experts
Timepoint [5] 410714 0
Two months post birth of final participant in pilot study
Secondary outcome [6] 410716 0
Investigate women’s satisfaction with their care (including what they did and did not like about telehealth and how it could be improved) using specifically designed questions for this study
Timepoint [6] 410716 0
Assessed two months post birth of baby at telephone based survey
Secondary outcome [7] 410717 0
Explore clinicians’ views of telehealth use using a specifically designed online survey for this study
Timepoint [7] 410717 0
Three months post closure of online survey (online survey will be closed four months after birth of last baby in the study)
Secondary outcome [8] 410718 0
Establish what other data would need to be collected (e.g. for costing the two trial arms) in the larger study by assessed by accessing patient electronic or paper medical record and reviewing data collection tools (recruitment survey and two month post birth survey)
Timepoint [8] 410718 0
Two months post birth of final participant in pilot study
Secondary outcome [9] 410719 0
Develop and test data collection tools that could be used for a future adequately powered RCT using specifically developed surveys at recruitment of participants and two months post birth of participants
Timepoint [9] 410719 0
Review data collection tools throughout pilot study, update as required and finalise two months post birth of final participant in pilot study
Secondary outcome [10] 410720 0
Estimate costs and develop cost framework for larger RCT assessed by accessing patient electronic or paper medical records for costs of telehealth and face to face appointments and using specifically designed costing questions in two month post birth survey
Timepoint [10] 410720 0
Throughout pilot trial and two months post birth of final participant in pilot study

Eligibility
Key inclusion criteria
Women with a singleton pregnancy attending either study sites as a public patient, planning to have their baby at study site and assessed as low obstetric risk, less than 24 weeks’ gestation, and able to speak and understand English.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will not be eligible if they meet any of the following:
• Require specialist care for alcohol and drug issues
• Are experiencing significant mental health issues
• Are unable to provide informed consent
• Do not have access to a suitable device (e.g. smart phone, computer, tablet) for video telehealth appointments
If they want to have their pregnancy care with an external provider (e.g. GP shared care), as the majority of care is provided by the external provider, and therefore it will be difficult to ensure the allocated trial arm schedule is adhered to by the external provider.

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)
A researcher not directly involved in the analysis of the study results or recruitment of participants will prepare the randomisation schedule using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be randomised by unbalanced block randomisation, with randomisation stratified by study site and parity (first baby or not in this case). The randomisation ratio will be 1:1 (i.e. approximately same number of women in each trial arm) each arm of the study.
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
Safety
Statistical methods / analysis
Given this is a pilot whose main aim is to see if it is possible to develop and implement the intervention and then see if women will take it up, and be willing to be randomised, we have estimated that 200 women will be adequate, approximately 100 per site. We will also be able to ascertain RCT potential uptake, as well as look at clinical outcome data to check if there is any obvious potential harm as a result of participating. We think this number will also provide adequate information about the proportion of women who actually receive all the scheduled video-health visits, as well as how many need to be changed to access additional care, and to check whether we can provide the necessary infrastructure and staff training to conduct this study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2022
Actual
11/08/2022
Date of last participant enrolment
Anticipated
16/12/2022
Actual
4/01/2023
Date of last data collection
Anticipated
11/08/2023
Actual
5/09/2023
Sample size
Target
200
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22532 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 22533 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 37771 0
3052 - Parkville
Recruitment postcode(s) [2] 37772 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 311615 0
Charities/Societies/Foundations
Name [1] 311615 0
Norman Beischer Medical Research Foundation
Country [1] 311615 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Judith Lumley Centre
Level 3, George Singer Building
Kingsbury Drive (no number)
La Trobe University
Bundoora 3086
Victoria
Country
Australia
Secondary sponsor category [1] 313052 0
None
Name [1] 313052 0
Address [1] 313052 0
Country [1] 313052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311057 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 311057 0
Ethics committee country [1] 311057 0
Australia
Date submitted for ethics approval [1] 311057 0
04/05/2022
Approval date [1] 311057 0
27/07/2022
Ethics approval number [1] 311057 0
HREC/86272/RWH-22-15
Ethics committee name [2] 311059 0
Mercy Health Human Ethics Committee
Ethics committee address [2] 311059 0
Ethics committee country [2] 311059 0
Australia
Date submitted for ethics approval [2] 311059 0
18/04/2022
Approval date [2] 311059 0
07/06/2022
Ethics approval number [2] 311059 0
2022-012
Ethics committee name [3] 311060 0
La Trobe University Human Research Ethics
Ethics committee address [3] 311060 0
Ethics committee country [3] 311060 0
Australia
Date submitted for ethics approval [3] 311060 0
24/06/2022
Approval date [3] 311060 0
Ethics approval number [3] 311060 0

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

Contacts
Principal investigator
Name 119846 0
Prof Della Forster
Address 119846 0
Judith Lumley Centre
Level 3, George Singer Building
Kingsbury Drive (no number)
La Trobe University
Bundoora 3086
Victoria
Country 119846 0
Australia
Phone 119846 0
+61 3 9479 8783
Fax 119846 0
Email 119846 0
[email protected]
Contact person for public queries
Name 119847 0
Robyn Matthews
Address 119847 0
The Royal Women’s Hospital
Locked Bag 300
Grattan St and Flemington Rd
Parkville VIC 3052
Country 119847 0
Australia
Phone 119847 0
+61 3 8345 2932
Fax 119847 0
Email 119847 0
[email protected]
Contact person for scientific queries
Name 119848 0
Touran Shafiei
Address 119848 0
Judith Lumley Centre
Level 3, George Singer Building
Kingsbury Drive (no number)
La Trobe University
Bundoora 3086
Victoria
Country 119848 0
Australia
Phone 119848 0
+61 3 94798798
Fax 119848 0
Email 119848 0
[email protected]

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 individual participant data of published data only. Data will only be available post completion of trial and by individual request with appropriate research questions and ethics permission
When will data be available (start and end dates)?
Post completion of trial. 30/12/23
Available to whom?
Only those with appropriate research questions and ethics permission
Available for what types of analyses?
To be discussed with Professor Della Forster when request is made
How or where can data be obtained?
By request of Principle investigator Professor Della Forster (email: [email protected])


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.