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

NCT07868991 | Not Yet Recruiting DMC

• 3 other identifiers: OPTIMISE_KI/K6_Cleeve2025-001822025
• Study Type: interventional
• Target: 978
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Medical Abortion

Keywords

No-test abortion; tele-abortion; telemedicin; medical abortion; randomised controlled trial

Outcome Measures

Primary Outcomes (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).

  42 days following mifepristone intake

Secondary Outcomes (20)

• Additional abortion treatment

  42 days following mifepristone intake

• Rates of complications

  42 days following mifepristone intake

• Ectopic pregnancy

  42 days following mifepristone intake

• Ectopic pregnancy

  42 days following mifepristone intake

• Ectopic pregnancy

  42 days following mifepristone intake

Other Outcomes (8)

• Testing

  42 days following mifepristone intake

• Additional contacts

  42 days following mifepristone intake

• Access: Distance to abortion clinic

  At baseline (postal code) and 42 days following mifepristone intake (abortion clinic)

Study Arms (2)

No-test tele-abortion

EXPERIMENTAL

'No-test' tele-abortion (intervention arm)

Other: no-test medical abortion

Standard care medical abortion

ACTIVE COMPARATOR

Standard care (control arm)

Other: Standard Care (in control arm)

Interventions

no-test medical abortion OTHER

'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.

Also known as: teleabortion

No-test tele-abortion

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.

Standard care medical abortion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Region Jämtland Härjedalen: collaborator
• Region Västerbotten: collaborator
• Region Norrbotten: collaborator
• Region Örebro County: collaborator

Study Sites (10)

Gällivare sjukhus

Gällivare, Sweden

Location

Karlskoga lasarett

Karlskoga, Sweden

Location

Lycksele Lasarett

Lycksele, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Östersunds sjukhus

Östersund, Sweden

Location

Skellefteå sjukhus

Skellefteå, Sweden

Location

Sunderby Sjukhus

Södra Sunderbyn, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Norrlands Universitetssjukhus

Umeå, Sweden

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amanda Cleeve, PhD, MSc, RNM

  Karolinska Institutet

  STUDY CHAIR

• Amanda Cleeve, PhD, MSc, RNM

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Karin Brandell, PhD, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Kristina Gemzell Danielsson, PhD, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Margit Endler, PhD, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Cleeve, PhD, MSc, RNM

CONTACT

+46737750911; Amanda.cleeve@ki.se

Karin Brandell, PhD, MD

CONTACT

0769011171; karin.brandell@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate prof, PhD, MSc, RNM

Model Details: Multicenter randomized controlled non-inferiority open trial

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available 12 months after publication of the primary study results and remain available for 5 years thereafter.
• Access Criteria: Access to de-identified participant-level data will be considered on a case-by-case basis. Requests must be accompanied by a detailed research proposal and evidence of appropriate ethical approval where applicable. Data sharing is subject to approval by the sponsor, execution of a data sharing agreement, and compliance with GDPR and Swedish legislation. The study investigators reserve the right to decline requests that are not scientifically justified, are not feasible, conflict with participant consent, or cannot be accommodated within regulatory requirements.

Locations

SE (10)