Telemedicin Counselling for Medical Abortion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2024-09-30

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.

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Detailed Description

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Conditions

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Medical Abortion Counselling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Telemedicine counselling

intervention group Women who will receive telemedicine counselling

Group Type OTHER

Telemedicine counselling

Intervention Type OTHER

women on web counselling

Standard care

Women who will receive standard face-to-face counselling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemedicine counselling

women on web counselling

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No