Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000890639
Ethics application status
Approved
Date submitted
24/07/2023
Date registered
21/08/2023
Date last updated
1/11/2023
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Mate whenua: follow up after early medical abortion
Scientific title
Feasibility of self-assessment of ongoing pregnancy after early medical abortion; an RCT
Secondary ID [1] 307562 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early medical abortion 327009 0
Condition category
Condition code
Reproductive Health and Childbirth 324189 324189 0 0
Abortion

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-assessment method of follow up after early medical abortion - using a low sensitivity urine pregnancy test at 3 weeks after taking medications (mifepristone). It takes 1-2 minutes, can be performed at home, and will be followed up by telephone or text with health practitioner.
Intervention code [1] 326780 0
Diagnosis / Prognosis
Comparator / control treatment
Serum beta hcg follow up after early medical abortion - comparing level at baseline to level at day 5 to 7 after taking medications (mifepristone). Results are available within 24 hours, is performed at a laboratory, and will be follow up by telephone or text with health practitioner.
Control group
Active

Outcomes
Primary outcome [1] 335187 0
Lost to follow up, using audit of patient medical records
Timepoint [1] 335187 0
6 weeks after early medical abortion (EMA)
Secondary outcome [1] 423419 0
timing of follow up test, using audit of patient medical records
Timepoint [1] 423419 0
6 weeks after EMA
Secondary outcome [2] 423479 0
Ongoing viable (live) pregnancy, using audit of patient medical records
Timepoint [2] 423479 0
up to 8 months after EMA
Secondary outcome [3] 423480 0
Successful abortion, defined as termination of pregnancy without need for surgery, audit of patient medical records
Timepoint [3] 423480 0
6 weeks after EMA
Secondary outcome [4] 423481 0
Incomplete abortion/retained pregnancy tissue/retained products of conception, audit of patient medical records
Timepoint [4] 423481 0
6 weeks after EMA
Secondary outcome [5] 423482 0
Haemorrhage, defined as estimated blood loss 500mL or more (categorised as requiring red blood cell transfusion or not), audit of patient medical records
Timepoint [5] 423482 0
6 weeks after EMA
Secondary outcome [6] 423483 0
Uterine infection, defined clinically as fever, tachycardia, tender on exam, or purulent vaginal discharge AND received broad spectrum intravenous antibiotics, audit of patient medical records
Timepoint [6] 423483 0
6 weeks after EMA
Secondary outcome [7] 423484 0
Uterine rupture, defined as clinically significant rupture involving the full thickness of the uterine wall and requiring surgical repair, audit of patient medical records
Timepoint [7] 423484 0
6 weeks after EMA
Secondary outcome [8] 423485 0
Additional investigations (categorised as blood test, pelvic ultrasound scan, or other), audit of patient medical records
Timepoint [8] 423485 0
6 weeks after EMA
Secondary outcome [9] 423486 0
Additional community prescription dispensed (categorised as antibiotics, painkillers, or other), audit of patient medical records
Timepoint [9] 423486 0
6 weeks after EMA
Secondary outcome [10] 423487 0
Additional health care visit (categorised as to abortion service, hospital emergency department or mental health service), audit of medical patient records
Timepoint [10] 423487 0
6 weeks after EMA
Secondary outcome [11] 423488 0
Surgical intervention, audit of patient medical records
Timepoint [11] 423488 0
6 weeks after EMA
Secondary outcome [12] 423489 0
Hospitalisation, audit of patient medical records
Timepoint [12] 423489 0
6 weeks after EMA
Secondary outcome [13] 423490 0
Admission to intensive care unit or equivalent, audit of patient medical records
Timepoint [13] 423490 0
6 weeks after EMA
Secondary outcome [14] 423491 0
Death
Timepoint [14] 423491 0
6 weeks after EMA
Secondary outcome [15] 423492 0
Patient experience, assessed by questionnaire developed specifically for this study, based on published similar patient experience questionnaires
Timepoint [15] 423492 0
6 weeks after EMA
Secondary outcome [16] 423493 0
ectopic pregnancy (categorised as ruptured or not), audit of patient medical records
Timepoint [16] 423493 0
6 weeks after EMA
Secondary outcome [17] 423494 0
Contraception use, assessed by patient questionnaire, developed specifically for this study
Timepoint [17] 423494 0
12 months after EMA
Secondary outcome [18] 423495 0
Pregnancy, assessed by patient questionnaire, developed specifically for this study
Timepoint [18] 423495 0
12 months after EMA
Secondary outcome [19] 423496 0
Pregnancy outcome (e.g. miscarriage, abortion, birth), assessed by patient questionnaire, developed specifically for this study
Timepoint [19] 423496 0
12 months after EMA
Secondary outcome [20] 423498 0
Seen the primary care health practitioner (if yes, main reason), assessed by patient questionnaire developed specifically for this study
Timepoint [20] 423498 0
12 months after EMA
Secondary outcome [21] 423499 0
Staff satisfaction, assessed by questionnaire developed specifically for this study, based on published similar staff satisfaction questionnaires
Timepoint [21] 423499 0
6 months into recruitment
Secondary outcome [22] 423501 0
Health care utilisation cost, using the dataset, and basing it on pharmaceutical, equipment and consumable costs, and health care utilisation cost
Timepoint [22] 423501 0
at end of trial
Secondary outcome [23] 423502 0
Incremental cost effective ratio for lost to follow up (LFU) rate, using the dataset
Timepoint [23] 423502 0
at end of trial
Secondary outcome [24] 425463 0
Gestational age in weeks at detection of ongoing pregnancy, audit of patient medical records
Timepoint [24] 425463 0
8 months after EMA
Secondary outcome [25] 425464 0
outcome of ongoing pregnancy (categorised as live birth, stillbirth, miscarriage, ectopic pregnancy, surgical abortion, medical abortion), audit of patient medical records
Timepoint [25] 425464 0
8 months after EMA
Secondary outcome [26] 425465 0
number of additional investigations, audit of medical patient records
Timepoint [26] 425465 0
6 weeks after EMA
Secondary outcome [27] 425466 0
number of additional prescriptions, audit of patient medical records
Timepoint [27] 425466 0
6 weeks after EMA
Secondary outcome [28] 425467 0
number of additional health care visits, audit of patient medical records
Timepoint [28] 425467 0
6 weeks after EMA
Secondary outcome [29] 425468 0
type of additional surgical intervention, audit of medical patient records
Timepoint [29] 425468 0
6 weeks after EMA
Secondary outcome [30] 425469 0
length of stay in intensive care, audit of patient medical records
Timepoint [30] 425469 0
6 weeks after EMA
Secondary outcome [31] 425470 0
primary reason for admission to intensive care, audit of patient medical records
Timepoint [31] 425470 0
6 weeks after EMA

Eligibility
Key inclusion criteria
Included are women having an early medical abortion at 10.0 weeks' pregnant or less, who provide informed consent.
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded are women over 10.0 weeks pregnant, or where the health practitioner believes that a specific method of follow up is contraindicated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using RedCap randomisation module on a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation (varying block sizes of 2 and 4), and stratified by centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline demographic and clinical characteristics of each study group will be described. Analyses will follow the principle of intention-to-treat, where participants will be analysed according to the assigned treatment group at randomisation. Multivariable models will control for potentially confounding variables. Binary outcomes will be analysed using log-binomial regression. Continuous outcomes will be analysed using multiple linear regression modelling or non-parametric analysis. A p-value of 0.05 will be considered to be statistically significant. Per-protocol sensitivity analyses will also be conducted excluding participants who had major protocol violations.
Non-inferiority for the ongoing live pregnancy outcome will be evaluated by observing whether the lower bound of the two-sided 95% confidence intervals for the difference between the two groups is above the non-inferiority limit of -5. If non-inferiority is evident, assessment as to whether the intervention group has effectiveness superior to that of standard care will be carried out using the same approach but comparing to a zero difference.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
27/10/2023
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
736
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 25611 0
New Zealand
State/province [1] 25611 0
Nationally

Funding & Sponsors
Funding source category [1] 311837 0
Government body
Name [1] 311837 0
Health Research Council New Zealand
Country [1] 311837 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 313312 0
None
Name [1] 313312 0
Address [1] 313312 0
Country [1] 313312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311279 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 311279 0
Ethics committee country [1] 311279 0
New Zealand
Date submitted for ethics approval [1] 311279 0
06/06/2023
Approval date [1] 311279 0
15/06/2023
Ethics approval number [1] 311279 0

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

Contacts
Principal investigator
Name 120550 0
A/Prof Michelle R Wise
Address 120550 0
The University of Auckland
Level 1, Building 507, 22-30 Park Avenue Grafton
Auckland
1023
Country 120550 0
New Zealand
Phone 120550 0
+64 21302978
Fax 120550 0
Email 120550 0
[email protected]
Contact person for public queries
Name 120551 0
Ashleigh O'Mara Baker
Address 120551 0
The University of Auckland
Level 1, Building 507, 22-30 Park Avenue Grafton
Auckland
1023
Country 120551 0
New Zealand
Phone 120551 0
+64 93737599
Fax 120551 0
Email 120551 0
[email protected]
Contact person for scientific queries
Name 120552 0
Michelle Wise
Address 120552 0
The University of Auckland
Level 1, Building 507, 22-30 Park Avenue Grafton
Auckland
1023
Country 120552 0
New Zealand
Phone 120552 0
+64 21302978
Fax 120552 0
Email 120552 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?
deidentified dataset including all of the individual participant data collected during the trial
When will data be available (start and end dates)?
after primary paper is published, with no end date
Available to whom?
to other PIs
Available for what types of analyses?
to be determined
How or where can data be obtained?
on request to the PI, email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20007Ethical approval    384373-(Uploaded-14-08-2023-09-24-28)-Study-related document.pdf
20008Study protocol  [email protected]
20009Statistical analysis plan  [email protected]
20010Informed consent form  [email protected]



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.