Telemedicin Counselling for Medical Abortion

Not Applicable

Completed

• Conditions: Medical Abortion Counselling
• Interventions: Other: Telemedicine counselling

• Registration Number: NCT03461653
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-12
• Study Start: 2018-04-04
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1508

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine counselling	Telemedicine counselling	intervention group Women who will receive telemedicine counselling

Primary Outcome Measures

Name	Time	Method
Proportion of women with complete abortion	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

Name	Time	Method
Proportions of women who would chose the same mode of provision in case of a future medical abortion	30 days	satisfaction with mode of counselling. Follow up questionnaire
Rate of reported complications that require additional treatment.	30 days	complications defined as; infection, bleeding Reported at follow up or

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden