Medical Abortion
Conditions
Keywords
Medical abortion, Termination of pregnancy, Mifepristone, Misoprostol, Urine hCG, Follow Up, Termination of unwanted pregnancy. Self assessment (follow up) after medical abortion
Brief summary
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.
Interventions
OTHERHome 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.
Sponsors
Ullevaal University Hospital
University of Helsinki
Gynmed Clinic Vienna
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at \< /=63 days of gestation, with no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent will be eligible for study recruitment.
Exclusion criteria
* women who do not wish to participate * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of complete abortions | Until 3 months post treatment | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postabortion contraception | until 12 months post treatment | The use of contraception and rate of repeat abortion at follow-up questionnaire at one year. |
| adverse events | util 3 months post treatment | Number of women reporting adverse events and side effects including infections, bleeding, pain |
Countries
Austria, Finland, Norway, Sweden
Outcome results
None listed