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Telemedicin Counselling for Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03461653
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet

Study Description
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Brief Summary:
The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of medical abortion through wow is safe, acceptable and with outcomes similar to medical abortion provided traditionally following face-to-face counselling. Furthermore, recently home self-assessment of the abortion outcome through a low sensitivity U-hCg test was shown to be highly acceptable to women. To evaluate whether counselling through telemedicine is non-inferior to face-to face counselling a RCT will be conducted including women who chose medical abortion up to 63 days of gestation with home administration of misoprostol and self assessment of the outcome. The results of this study could be of major importance to increase access to safe and acceptable abortion services.

Condition or disease Intervention/treatment Phase
Medical Abortion Counselling Other: Telemedicine counselling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Efficacy of Medical Abortion Through Telemedicine Versus Standard Provision - a Randomised Controlled Non-inferiority Trial
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : November 28, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arms and Interventions
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Arm Intervention/treatment
Telemedicine counselling
intervention group Women who will receive telemedicine counselling
 Other: Telemedicine counselling
women on web counselling
No Intervention: Standard care
Women who will receive standard face-to-face counselling


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of women with complete abortion [ Time Frame: 30 days of abortion treatment ]
    Efficacy of medical abortion defined as complete abortion without ongoing intrauterine pregnancy or surgical intervention for incomplete abortion within 30 days of the abortion treatment.Reported by the patient in the follow up questionnaire and by assessment of patient records


Secondary Outcome Measures :
  1. Rate of reported complications that require additional treatment. [ Time Frame: 30 days ]
    complications defined as; infection, bleeding Reported at follow up or

  2. Proportions of women who would chose the same mode of provision in case of a future medical abortion [ Time Frame: 30 days ]
    satisfaction with mode of counselling. Follow up questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at < /=63 days of gestation, no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent

Exclusion Criteria:

  • women who do not want home administration of misoprostol, women who are unable to communicate in Swedish, or English, and women with symptoms and signs of ectopic pregnancy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461653


Contacts
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Contact: Kristina Gemzell Danielsson, MD, PhD +46851772128 kristina.gemzell@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Kristina Gemzell Danielsson       kristina.gemzell@ki.se   
Sponsors and Collaborators
Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Kristina Gemzell Danielsson, Karolinska Institutet:
Study Protocol and Statistical Analysis Plan  [PDF] May 8, 2000

More Information
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Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03461653    
Other Study ID Numbers: wow2018
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No