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Telemedicin Counselling for Medical Abortion

Karolinska Institute logo

Karolinska Institute

Status

Completed

Conditions

Medical Abortion Counselling

Treatments

Other: Telemedicine counselling

Study type

Interventional

Funder types

Other

Identifiers

NCT03461653
wow2018

Details and patient eligibility

About

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.

Enrollment

1,598 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,598 participants in 2 patient groups

Telemedicine counselling
Other group
Description:
intervention group Women who will receive telemedicine counselling
Treatment:
Other: Telemedicine counselling
Standard care
No Intervention group
Description:
Women who will receive standard face-to-face counselling

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Kristina Gemzell Danielsson, MD, PhD

Data sourced from clinicaltrials.gov

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