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Medical AbortionOPTIMISENCT07868991

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

A study testing no-test medical abortion in people with Medical Abortion, run by Karolinska Institutet at 10 sites in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Medical Abortion
What is being tested?
no-test medical abortion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
978 participants
Where
10 sitesSweden
Study dates
Dec 2026to Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant less than or equal to 10+0 weeks according to date for the LMP
  • Age ≥18 years
  • Wiling to perform MA at home
  • Regular menses prior to this pregnancy
  • Willing to undergo an abortion without prior clinical examinations (gynaecological examination and ultrasound)
  • Willing and able to receive information remotely
  • Willing and able to provide electronic informed consent

Who cannot join

  • Contraindications to MA (known allergy to mifepristone or misoprostol)
  • Health condition requiring in-clinic abortion
  • Uncertainty around the dates for LMP,
  • Hormonal contraception used < 3 months
  • 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)
  • Symptoms of pathologic pregnancy (bleeding and/or pain)
  • No proficiency in Swedish or English

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Amanda Cleeve, PhD, MSc, RNM contact

+46737750911

Amanda.cleeve@ki.se

Karin Brandell, PhD, MD contact

0769011171

karin.brandell@ki.se

10 sites in 1 country

Sweden10 sites

  • Gällivare sjukhus

    Gällivare

    Helena Carré, PhD, MD, helena.carre@norrbotten.se

  • Karlskoga lasarett

    Karlskoga

    Jan Brynhildsen, PhD, MD, jan.brynhildsen@oru.se

  • Lycksele Lasarett

    Lycksele

    Ulrika Ottander, PhD, MD, ulrika.ottander@umu.se

  • Örebro University Hospital

    Örebro

    Jan Brynhildsen, PhD, MD, jan.brynhildsen@oru.se

  • Östersunds sjukhus

    Östersund

    Malin Huber, PhD, MD, malin.huber@umu.se

  • Skellefteå sjukhus

    Skellefteå

    Ulrika Ottander, PhD, MD, ulrika.ottander@umu.se

  • Sunderby Sjukhus

    Södra Sunderbyn

    Helena Carré, PhD, MD, helena.carre@norrbotten.se

  • Karolinska University Hospital

    Stockholm

    Karin Brandell, PhD, MD, karin.brandell@ki.se

  • Södersjukhuset

    Stockholm

    Gustaf Rejnö, PhD, MD, gustaf.rejno@regionstockholm.se

  • Norrlands Universitetssjukhus

    Umeå

    Ulrika Ottander, PhD, MD, ulrika.ottander@umu.se

Other trials in Sweden

About this study

Official title: Optimising Healthcare Access Through 'No-Test' Tele-Abortion: a Multi-centre Randomised Controlled Trial in Sweden (OPTIMISE)

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:

Read more
  • 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.

Being tested
no-test medical abortion, Standard Care (in control arm)
Keywords
No-test abortion, tele-abortion, telemedicin, medical abortion, randomised controlled trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no-test medical abortionOther

    Also called teleabortion

    '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)Other

    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 groups in NCT07868991
Study groupRoleWhat they receive
No-test tele-abortionExperimental'No-test' tele-abortion (intervention arm)
Receives: Other: no-test medical abortion
Standard care medical abortionActive comparatorStandard care (control arm)
Receives: Other: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete abortion

    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).

    Measured: 42 days following mifepristone intake

Secondary outcomes (20)

  1. Additional abortion treatment

    Any additional treatment the participant has received to complete the abortion including medical (misoprostol or mifepristone and misoprostol) or surgical (uterine aspiration) treatment

    Measured: 42 days following mifepristone intake

  2. Rates of complications

    Rates of complications: incomplete abortion, ongoing pregnancy, surgical intervention, infection requiring treatment, ectopic pregnancy not requiring surgery (Adverse Events) and hospitalisation ≥24 hours, blood transfusion, ectopic pregnancy requiring surgery, deaths (Serious Adverse Events).

    Measured: 42 days following mifepristone intake

  3. Ectopic pregnancy

    Ectopic pregnancy: time to diagnosis from study inclusion (days,hours)

    Measured: 42 days following mifepristone intake

  4. Ectopic pregnancy

    Ectopic pregnancy: complication such as rupture (yes/no)

    Measured: 42 days following mifepristone intake

  5. Ectopic pregnancy

    Ectopic pregnancy: S-hcg level at diagnosis

    Measured: 42 days following mifepristone intake

  6. Ectopic pregnancy

    Ectopic pregnancy: treatment (expectant management, medical treatment, surgical treatment)

    Measured: 42 days following mifepristone intake

  7. Gestational age at treatment

    Gestational length at time of initiating treatment (mifepristone intake). Measured in weeks and days (by dates for the Last Menstrual Period (LMP) and ultrasound when available). LMP collected at baseline, date of mifepristone collected at the follow-up survey. Ultrasound dating collected from the endline review of medical records.

    Measured: LMP collected at baseline. Date of mifepristone collected at the follow-up survey. Ultrasound dating collected from the endline review of medical records (42 days following abortion (mifepristone intake).

  8. Underestimation of gestational age

    Proportion of underestimation (>10+0 weeks) of gestational age detected on ultrasound (LMP at baseline vs ultrasound findings).

    Measured: 42 days following mifepristone intake

  9. Severe pain

    Pain defined as Numeric Rating Scale (NRS) >7

    Measured: 42 days following mifepristone intake

  10. Bleeding days

    Number of days bleeding (requiring a pad or similar)

    Measured: 42 days following mifepristone intake

  11. Bleeding amount

    Bleeding in relation to menstruation (more/similar or less than a normal menstruation) measured at the follow-up survey.

    Measured: 42 days following mifepristone intake

  12. Access: time to accessing treatment

    Time to accessing treatment (from inclusion in the study to the pick-up visit/in-clinic visit; days).

    Measured: 42 days following mifepristone intake

  13. Access: Travel time to access treatment

    Travel time to access abortion medications. Measured in hours and minutes

    Measured: 42 days following mifepristone intake

  14. Access: Time to initiating treatment

    Time to initiating treatment (from inclusion in the study to mifepristone intake; days)

    Measured: 42 days following mifepristone intake

  15. Postabortion contraceptive use

    Measured in use at follow-up categorised as Long-Acting Reversible Contraception (LARC), Short Acting Reversible Contraception (SARC), barrier methods, natural family planning methods (NPF), sterilization and emergency contraception

    Measured: 42 days of the medical abortion (mifepristone intake)

  16. Satisfaction with care

    Short Assessment of Patient Satisfaction Scale (SAPS). The SAPS scale contains 7 questions with 5 response options scored 0-4: very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied. The questions assess satisfaction with:

    1. the effectiveness of treatment
    2. information provision
    3. technical skills of the healthcare provider
    4. involvement in decision-making
    5. the patient-provider interaction
    6. time with the healthcare provider
    7. overall, with the care received

    Measured: 42 days of the medical abortion (mifepristone intake)

  17. Satisfaction with care

    Overall satisfaction with care using a likert scale

    Measured: 42 days following mifepristone intake

  18. Satisfaction with care

    Whether the participant would choose the same model of care again in case of wanting another abortion in the future

    Measured: 42 days following mifepristone intake

  19. Satisfaction with care

    Whether the participant would recommend the model of care received to a friend

    Measured: 42 days following mifepristone intake

  20. Satisfaction with information

    Satisfaction with information sources using a likert scale (5 options)

    Measured: 42 days following mifepristone intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter randomized controlled non-inferiority open trial
Masking
None (open label)
Enrolment
978 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07868991
Sponsor's protocol ID
OPTIMISE_KI/K6_Cleeve
Other IDs
2025-00182, 2025
Acronym
OPTIMISE
Status last verified
Oct 2026
First submitted
4 Sep 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD Sharing Plan Individual participant data that underlie the results reported in publications arising from this study, after de-identification, will be made available. Data shared will include participant-level data necessary to reproduce the published findings. Supporting Information Available Study protocol, statistical analysis plan, and data dictionary.

Questions about this trial

What is this clinical trial studying?

A study testing no-test medical abortion in people with Medical Abortion, run by Karolinska Institutet at 10 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amanda Cleeve, PhD, MSc, RNM (+46737750911, Amanda.cleeve@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete abortion (time frame: 42 days following mifepristone intake). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07868991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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