Telemedicin Counselling for Medical Abortion

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Medical Abortion Through Telemedicine Versus Standard Provision - a Randomised Controlled Non-inferiority Trial

Conditions
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Medical Abortion Counselling

Intervention / Treatment
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* Other: Telemedicine counselling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Telemedicine counselling<br>intervention group Women who will receive telemedicine counselling | Other: Telemedicine counselling<br>* women on web counselling<br>|
| No Intervention: Standard care<br>Women who will receive standard face-to-face counselling | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women with complete abortion | 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 | 30 days of abortion treatment | 

Secondary Outcome Measures

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