Routine Follow-up Versus Self-assessment in Medical Abortion

Study Overview
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Brief Summary
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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.

Official Title
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Routine Follow-up Versus Self-assessment of Complete Abortion Following Medical Abortion, Effect on Its Success and Acceptability: a Randomized Controlled Trial

Conditions
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Medical Abortion

Intervention / Treatment
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* Other: Home self assessment of complete medical abortion


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Controls<br>Routine follow-up at the clinic 2-3 weeks after the treatment | |
| Other: Home self test<br>Intervention | Other: Home self assessment of complete medical abortion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | util 3 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical abortion, Termination of pregnancy, Mifepristone, Misoprostol, Urine hCG, Follow Up, Termination of unwanted pregnancy. Self assessment (follow up) after medical abortion