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Clinical Trials in Sweden / NCT07868991
Starting soon Not applicable

'No-test' Tele-abortion: a Multi-centre Randomised Controlled Trial

NCT07868991 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Not applicable
Started
2026-12
Last updated
2026-10-09

Condition(s) studied

Medical Abortion

Investigational drug(s) / intervention(s)

no-test medical abortionStandard Care (in control arm)

no-test medical abortion: 'No-test' tele-abortion i.e., medical abortion delivered via telecommunications (phone and web-based) and the medical abortion self-managed at home. Prior in clinic-visit with routine testing (ultrasound, pelvic exam) is omitted and the eligibility assessment is history-based. To meet current legal requirements, mifepristone is taken during a brief in-clinic pick-up visit of a medical abortion kit.

Standard Care (in control arm): Standard care defined as in-clinic provision of medical abortion, delivered during one in-clinic consultation with routine testing (ultrasound, pelvic exam), information provision and mifepristone-intake, followed by misoprostol intake at home.

Study summary

Brief Summary The goal of this clinical trial is to learn whether a no-test telemedicine medical abortion model can provide abortion care that is as effective and safe as standard clinic-based medical abortion care among women aged 18 years and older with an early pregnancy who wish to have a medical abortion at home.

The main questions it aims to answer are:

* Is no-test telemedicine medical abortion (without routine ultrasound) as effective as standard clinic-based medical abortion (with routine ultrasound) in achieving complete abortion?
* Is no-test telemedicine medical abortion as safe, acceptable, and cost-effective as standard clinic-based medical abortion? Researchers will compare no-test telemedicine medical abortion to standard clinic-based medical abortion to determine whether the telemedicine model results in similar effectiveness and safety outcomes while improving access to care.

Participants will:

* Be randomly assigned to receive either no-test telemedicine medical abortion or standard clinic-based medical abortion.
* Receive counseling and clinical assessment according to their assigned care model.
* Use medical abortion treatment at home.
* Complete follow-up assessments approximately 6 weeks after the abortion.
* Provide information about treatment outcomes, complications, healthcare contacts, satisfaction with care, and contraceptive use.

This study will enroll 978 women across five healthcare regions in Sweden. The results will inform future evidence-based guidelines for medical abortion care and may improve access to abortion services, particularly for individuals living in rural and underserved areas.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Pregnant less than or equal to 10+0 weeks according to date for the LMP 2. Age ≥18 years 3. Wiling to perform MA at home 4. Regular menses prior to this pregnancy 5. Willing to undergo an abortion without prior clinical examinations (gynaecological examination and ultrasound) 6. Willing and able to receive information remotely 7. Willing and able to provide electronic informed consent Exclusion Criteria: 1. Contraindications to MA (known allergy to mifepristone or misoprostol) 2. Health condition requiring in-clinic abortion 3. Uncertainty around the dates for LMP, 4. Hormonal contraception used \< 3 months 5. Risk factors for ectopic pregnancy (previous ectopic pregnancy, previous tubal surgery or tubal ligation, use of intrauterine contraception at conception, signs of pelvic inflammatory disease) 6. Symptoms of pathologic pregnancy (bleeding and/or pain) 7. No proficiency in Swedish or English

Primary outcome measure(s)

  • Complete abortion — 42 days following mifepristone intake
    Effectiveness of 'no-test' tele-abortion, measured in the proportion of complete abortion with no ongoing pregnancy or surgical intervention for incomplete abortion, within 42 days of the medical abortion (mifepristone intake).

Trial sites (10)

FacilityCityRegionStatus
Gällivare sjukhus Gällivare Sweden
Karlskoga lasarett Karlskoga Sweden
Lycksele Lasarett Lycksele Sweden
Örebro University Hospital Örebro Sweden
Östersunds sjukhus Östersund Sweden
Skellefteå sjukhus Skellefteå Sweden
Sunderby Sjukhus Södra Sunderbyn Sweden
Karolinska University Hospital Stockholm Sweden
Södersjukhuset Stockholm Sweden
Norrlands Universitetssjukhus Umeå Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07868991 on ClinicalTrials.gov ↗ ← All trials in Sweden