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OpenTrials
Completed

NCT Number: NCT01487213

Routine Follow-up Versus Self-assessment in Medical Abortion

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.

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Key information

Conditions

Medical Abortion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GynMed Clinic, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Home self assessment of complete medical abortion

Other

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.

Primary outcomes

  1. Number of complete abortions

    Time frame: 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 outcomes

  1. postabortion contraception

    Time frame: until 12 months post treatment

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

  2. adverse events

    Time frame: util 3 months post treatment

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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Gynmed Clinic Vienna
  • Ullevaal University Hospital
  • University of Helsinki

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 7, 2011
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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