Routine Follow-up Versus Self-assessment in Medical Abortion

Karolinska Institutet929 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

929

Conditions

Medical Abortion

Interventions

Home self assessment of complete medical abortionOTHER

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

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (4)

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

Outcomes

Primary Outcomes

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%.

Time frame: Until 3 months post treatment

Secondary Outcomes

postabortion contraception

The use of contraception and rate of repeat abortion at follow-up questionnaire at one year.

Time frame: until 12 months post treatment

adverse events

Number of women reporting adverse events and side effects including infections, bleeding, pain

Time frame: util 3 months post treatment

Data from ClinicalTrials.gov

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