Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000819527
Ethics application status
Approved
Date submitted
14/05/2024
Date registered
3/07/2024
Date last updated
3/07/2024
Date data sharing statement initially provided
3/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Administrative intervention to support testing after gestational diabetes and hypertensive disorders in pregnancy
Scientific title
POST-IT: A randomised controlled trial to evaluate a POSTpartum Intervention to support adherence to recommended Testing in women diagnosed with gestational diabetes and hypertensive disorders
Secondary ID [1] 311991 0
None
Universal Trial Number (UTN)
Trial acronym
POST-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes mellitus 333605 0
Hypertensive disorder in pregnancy 333606 0
Condition category
Condition code
Reproductive Health and Childbirth 330290 330290 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 330567 330567 0 0
Diabetes
Cardiovascular 330568 330568 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of personalised administrative assistance to attend the recommended postpartum 6-week GP review and undergo recommended postpartum testing after gestational diabetes (GDM) and hypertensive disorders of pregnancy (HDP) in keeping with current recommendations.

This will include:
1. Booking the appointment with the participant's GP at a day and time of their choosing
2. Provision of pathology forms for oral glucose tolerance test (OGTT) (if GDM); and for 24 hour blood pressure monitor, urinary protein:creatinine ratio and blood tests for fasting lipids and glucose (if HDP).
4. Booking of OGTT (if GDM) at pathology centre of participant's choice at 12 weeks postpartum.

The participant will be provided with a single page summary of the appointments.

The personalised administrative assistance is provided by the PhD student investigator on the study team. This is provided either at or after 36 weeks for those recruited antenatally, and within one week postpartum for those recruited postpartum.

Fidelity to the intervention will be assessed primarily at the four month survey for all participants. A subset will also undergo validation by correspondence with the participant's GP, for those who provide consent to do so during the participant recruitment and consent process.

Validation involves the following: no active participation from participants. Contact with consenting participants' primary care practitioner will be performed for this subset, and data on a. whether a six week visit was performed; b. whether an OGTT or other diabetes screening test has been performed postpartum, and when (for those with GDM); and c. whether additional testing after hypertensive disorder in pregnancy has been performed, and which tests these are.

The timing of this subset validation will be: six months postpartum, i.e. two months following the participant's four month survey.
Intervention code [1] 328452 0
Behaviour
Intervention code [2] 328502 0
Early detection / Screening
Comparator / control treatment
Control - standard of care

Standard of care is defined as care provided by the usual medical and obstetric team in keeping with usual practice. This predominantly includes written information on a discharge summary advising women of their recommended follow up with their GP and recommended postpartum testing, but does not include assistance beyond this.
Control group
Active

Outcomes
Primary outcome [1] 338032 0
Uptake of recommended postpartum testing (OGTT, recommended testing for HDP)
Timepoint [1] 338032 0
4 months post-delivery.
Secondary outcome [1] 434207 0
1. Attendance at six week check
Timepoint [1] 434207 0
4 months post-delivery
Secondary outcome [2] 434596 0
2. Comparison of uptake of postpartum care between groups with GDP and HDP
Timepoint [2] 434596 0
Four months post-delivery
Secondary outcome [3] 434597 0
3. Attitudes towards intervention among participants in intervention arm
Timepoint [3] 434597 0
Four months post-delivery
Secondary outcome [4] 434598 0
4. Recollection of being asked about mental health during postpartum visit
Timepoint [4] 434598 0
Four months post-delivery

Eligibility
Key inclusion criteria
Planning to receive all antenatal care at site of study recruitment
Diagnosed with HDP or GDM at any point during pregnancy
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged <18 years
Past history of hypertension, Type 1 or Type 2 diabetes or Mature Onset Diabetes of the Young (MODY) that predates current pregnancy and for which they receive long term healthcare follow up
Diagnosis of severe GDM or HDP with activation of alternative specialist postpartum pathways: endocrinologist (GDM with complex management needs or concern for pre-existing Type 1 diabetes or MODY); or nephrologist (severe pre-eclampsia, eclampsia, or Haemolysis/Elevated Liver enzymes/Low platelets HELLP syndrome).
Residence interstate/overseas and planning to complete postpartum care outside of Victoria.
Women who have had a fetal death in utero or stillbirth; if already recruited, then they will automatically be withdrawn from the study.
Women who have complex medical or psychiatric needs in the peripartum period requiring extended stay (> two weeks, or > one week in Intensive Care Unit) postpartum; or otherwise deemed unsuitable at the discretion of the researcher/clinician.
Women who are incarcerated, who do not speak English and there is no interpreter available to obtain consent
Women who give birth prior to 32 weeks where an alternate postpartum pathway is in situ for follow-up

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment in place: randomisation not performed until after recruitment, performed by central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software (using atmospheric noise to generate true random number generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A study sample size of 72 per group (144 total) is required to detect a difference with 80% power and an alpha cut-off of 5%. This is based on an estimate of 2000 women being eligible over 12 months, using a baseline rate of attendance for postpartum testing of 50%, and to identify a difference between a control and intervention group, and a minimal detection effect of 20%.

The proportion of women who undergo recommended postpartum testing, will be compared between those randomised to the intervention, and those randomized to control. Other factors included in the analysis will include maternal age, parity, site of delivery, level of education, shared care versus hospital-based care, region of birth, English-speaking/not, and co-existence of GDM and HIP.

The proportions of those who complete recommended postpartum testing will be compared between the control and intervention group using the Chi square test. Logistic regression will be used to determine if undergoing the intervention is superior to no intervention for the study outcomes of attendance at the six week check and completion of recommended postpartum tests, when co-existing factors are taken into account. Unadjusted and adjusted odds ratios and their 95% confidence intervals will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/12/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
144
Accrual to date
66
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26495 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 26496 0
Casey Hospital - Berwick
Recruitment hospital [3] 26497 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment postcode(s) [1] 42537 0
3168 - Clayton
Recruitment postcode(s) [2] 42538 0
3806 - Berwick
Recruitment postcode(s) [3] 42539 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 316339 0
Hospital
Name [1] 316339 0
Monash Health
Country [1] 316339 0
Australia
Primary sponsor type
Individual
Name
Prof Michelle Giles, Department of Obstetrics, Monash Health, 246 Clayton Road, Melbourne, Vic 3168
Address
Country
Australia
Secondary sponsor category [1] 318521 0
None
Name [1] 318521 0
Address [1] 318521 0
Country [1] 318521 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315149 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315149 0
Ethics committee country [1] 315149 0
Australia
Date submitted for ethics approval [1] 315149 0
20/09/2023
Approval date [1] 315149 0
04/12/2023
Ethics approval number [1] 315149 0

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

Contacts
Principal investigator
Name 133826 0
Prof Michelle Giles
Address 133826 0
Department of Obstetrics, Monash Health, 246 Clayton Road, Melbourne, Vic 3168
Country 133826 0
Australia
Phone 133826 0
+61 0395944564
Fax 133826 0
Email 133826 0
[email protected]
Contact person for public queries
Name 133827 0
Dr Naomi Whyler
Address 133827 0
Department of Obstetrics, Monash Health, 246 Clayton Road, Melbourne, Vic 3168
Country 133827 0
Australia
Phone 133827 0
+61 0395944564
Fax 133827 0
Email 133827 0
[email protected]
Contact person for scientific queries
Name 133828 0
Dr Naomi Whyler
Address 133828 0
Department of Obstetrics, Monash Health, 246 Clayton Road, Melbourne, Vic 3168
Country 133828 0
Australia
Phone 133828 0
+61 0395944564
Fax 133828 0
Email 133828 0
[email protected]

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?

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.