Routine Follow-up Versus Self-assessment in Medical Abortion
NCT ID: NCT01487213
Last Updated: 2013-08-07
Study Results
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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COMPLETED
NA
929 participants
INTERVENTIONAL
2011-09-30
2013-07-31
Brief Summary
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This will be achieved by providing means for women for postabortal self-assessment with the use of a quantitative urinary hCG test.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Controls
Routine follow-up at the clinic 2-3 weeks after the treatment
No interventions assigned to this group
Home self test
Intervention
Home self assessment of complete medical abortion
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.
Interventions
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Home self assessment of complete medical abortion
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* women who do not want home administration of misoprostol
* women who are unable to communicate in Swedish, Norwegian, English, Finnish or German and women with symptoms and signs of ectopic pregnancy
* minors (i.e. women \< 18 years of age) will not be enrolled for the study.
* women seeking termination of pregnancy with no sign of a visible intrauterine pregnancy (i.e. visible intrauterine yolk sac).
18 Years
FEMALE
No
Sponsors
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Ullevaal University Hospital
OTHER
University of Helsinki
OTHER
Gynmed Clinic Vienna
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Kristina Gemzell Danielsson
professor, MD, PhD
Principal Investigators
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Kristina Gemzell-Danielsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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GynMed Clinic
Vienna, , Austria
Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital
Helsinki, , Finland
Faculty of Medicine, University of Oslo and Dept. of Gynaecology,
Oslo, , Norway
Dept of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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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.
Other Identifiers
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WNI1000
Identifier Type: -
Identifier Source: org_study_id