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Mate whenua: follow up after early medical abortion

Feasibility of self-assessment of ongoing pregnancy after early medical abortion; an RCT

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000890639
Enrollment
736
Registered
2023-08-21
Start date
2023-10-27
Completion date
2025-07-02
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

One in four women in Aotearoa New Zealand (NZ) will have an abortion during her lifetime. Recent abortion law reform, and current health care reform, on a background of a pandemic-fuelled health workforce crisis and a paradigm shift to telehealth, creates the perfect opportunity for this research project to be relevant and timely. This research will progress knowledge about abortion in a NZ context, and the findings will fill a global knowledge gap. Early medical abortion (EMA) is safe and effective; an uncommon but crucial outcome is ongoing live pregnancy. The best method of follow up after EMA to detect ongoing pregnancy is a critical research gap. Few trials compare blood or urine pregnancy tests to ultrasound scan, and no trial compares these tests to each other. Half the abortion services in NZ use comparative blood tests whilst the other half use self-assessment; services estimate that 10-20% of women having an EMA have no follow up. Primary Aim: To assess the effectiveness of self-assessment follow up compared to serial blood test follow up on the rate of lost to follow up (LFU) in women having EMA. Secondary Aims: To assess other outcomes between the two methods of follow up: • Adverse and serious adverse events • Participant satisfaction and acceptability • Health practitioner satisfaction and acceptability • Cost effectiveness Almost 5,000 women have EMA each year. By applying the principle of partnership with wahine and whanau, we anticipate greater uptake with the follow up test, better detection of the uncommon but important outcome of ongoing live pregnancy, and a reduction in unplanned follow up care. Results of this study will inform women, health practitioners and the new national EMA telehealth service about how best to follow up after EMA. Self-assessment will potentially save significant resources in health practitioner time, testing costs, and direct contact with health services.

Interventions

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.

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Included are women having an early medical abortion at 10.0 weeks' pregnant or less, who provide informed consent.

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. Excluded are women who have participated in the trial previously..

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026