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.
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
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.
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
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.
- Conditions
- Medical Abortion
- 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 group | Role | What they receive |
|---|---|---|
| No-test tele-abortion | Experimental | 'No-test' tele-abortion (intervention arm) Receives: Other: no-test medical abortion |
| Standard care medical abortion | Active comparator | Standard 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.
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)
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
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
Ectopic pregnancy
Ectopic pregnancy: time to diagnosis from study inclusion (days,hours)
Measured: 42 days following mifepristone intake
Ectopic pregnancy
Ectopic pregnancy: complication such as rupture (yes/no)
Measured: 42 days following mifepristone intake
Ectopic pregnancy
Ectopic pregnancy: S-hcg level at diagnosis
Measured: 42 days following mifepristone intake
Ectopic pregnancy
Ectopic pregnancy: treatment (expectant management, medical treatment, surgical treatment)
Measured: 42 days following mifepristone intake
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).
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
Severe pain
Pain defined as Numeric Rating Scale (NRS) >7
Measured: 42 days following mifepristone intake
Bleeding days
Number of days bleeding (requiring a pad or similar)
Measured: 42 days following mifepristone intake
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
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
Access: Travel time to access treatment
Travel time to access abortion medications. Measured in hours and minutes
Measured: 42 days following mifepristone intake
Access: Time to initiating treatment
Time to initiating treatment (from inclusion in the study to mifepristone intake; days)
Measured: 42 days following mifepristone intake
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)
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:
- the effectiveness of treatment
- information provision
- technical skills of the healthcare provider
- involvement in decision-making
- the patient-provider interaction
- time with the healthcare provider
- overall, with the care received
Measured: 42 days of the medical abortion (mifepristone intake)
Satisfaction with care
Overall satisfaction with care using a likert scale
Measured: 42 days following mifepristone intake
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
Satisfaction with care
Whether the participant would recommend the model of care received to a friend
Measured: 42 days following mifepristone intake
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.
- First posted9 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical AbortionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Region Jämtland Härjedalen, Region Västerbotten, Region Norrbotten, Region Örebro County
- Responsible party
- Principal investigator, Amanda Cleeve, Karolinska Institutet
- Investigators
- Amanda Cleeve, PhD, MSc, RNM, Study chair, Karolinska InstitutetAmanda Cleeve, PhD, MSc, RNM, Principal investigator, Karolinska InstitutetKarin Brandell, PhD, MD, Principal investigator, Karolinska InstitutetKristina Gemzell Danielsson, PhD, MD, Principal investigator, Karolinska InstitutetMargit Endler, PhD, MD, Principal investigator, Karolinska Institutet
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.