Medical Abortion Counselling
Conditions
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.
Interventions
OTHERTelemedicine counselling
women on web counselling
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomised trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of reported complications that require additional treatment. | 30 days | complications defined as; infection, bleeding Reported at follow up or |
| 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 |
Countries
Sweden
Outcome results
None listed