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| Name | Class |
|---|---|
| Ullevaal University Hospital | OTHER |
| University of Helsinki | OTHER |
| Gynmed Clinic Vienna | OTHER |
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The main objective of the study is to optimize the routines for follow-up after medical abortion in order to give women more autonomy by reducing the number of consultations involved and to reduce the frequency of postabortal curettage.
This will be achieved by providing means for women for postabortal self-assessment with the use of a quantitative urinary hCG test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | No Intervention | Routine follow-up at the clinic 2-3 weeks after the treatment | |
| Home self test | Other | Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home self assessment of complete medical abortion | Other | Self assessment of complete abortion using a home semiquantitative U-hCG test. Follow-up out patient review two-three weeks later by qualified practitioner to evaluate success of procedure using the clinic's standard routine. The patient charts will be reviewed after three months in order to control for possible extra visits related to abortion-related complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of complete abortions | The primary objective is thus to demonstrate the non-inferiority of self-assessment of complete abortion following medical abortion compared to routine follow-up in terms of the percentage of women requiring surgical abortion, within a margin of non-inferiority of 5%. | Until 3 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| postabortion contraception | The use of contraception and rate of repeat abortion at follow-up questionnaire at one year. | until 12 months post treatment |
| adverse events | Number of women reporting adverse events and side effects including infections, bleeding, pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Gemzell-Danielsson, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GynMed Clinic | Vienna | Austria | ||||
| Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25468164 | Derived | Oppegaard KS, Qvigstad E, Fiala C, Heikinheimo O, Benson L, Gemzell-Danielsson K. Clinical follow-up compared with self-assessment of outcome after medical abortion: a multicentre, non-inferiority, randomised, controlled trial. Lancet. 2015 Feb 21;385(9969):698-704. doi: 10.1016/S0140-6736(14)61054-0. Epub 2014 Oct 30. |
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| util 3 months post treatment |
| Helsinki |
| Finland |
| Faculty of Medicine, University of Oslo and Dept. of Gynaecology, | Oslo | Norway |
| Dept of Obstetrics and Gynecology, Karolinska University Hospital | Stockholm | SE17176 | Sweden |