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Routine Follow-up Versus Self-assessment in Medical Abortion

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Karolinska Institute

Status

Completed

Conditions

Medical Abortion

Treatments

Other: Home self assessment of complete medical abortion

Study type

Interventional

Funder types

Other

Identifiers

NCT01487213
WNI1000

Details and patient eligibility

About

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.

Enrollment

929 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

929 participants in 2 patient groups

Controls
No Intervention group
Description:
Routine follow-up at the clinic 2-3 weeks after the treatment
Home self test
Other group
Description:
Intervention
Treatment:
Other: Home self assessment of complete medical abortion

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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