Routine Follow-up Versus Self-assessment in Medical Abortion

This study has been completed.
Sponsor:
Collaborators:
Ullevaal University Hospital
Helsinki University
GynMed Clinic, Vienna, Austria
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01487213
First received: December 2, 2011
Last updated: August 6, 2013
Last verified: August 2013

December 2, 2011
August 6, 2013
September 2011
July 2013   (final data collection date for primary outcome measure)
Number of complete abortions [ Time Frame: Until 3 months post treatment ] [ Designated as safety issue: Yes ]
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%.
Same as current
Complete list of historical versions of study NCT01487213 on ClinicalTrials.gov Archive Site
  • postabortion contraception [ Time Frame: until 12 months post treatment ] [ Designated as safety issue: No ]
    The use of contraception and rate of repeat abortion at follow-up questionnaire at one year.
  • adverse events [ Time Frame: util 3 months post treatment ] [ Designated as safety issue: Yes ]
    Number of women reporting adverse events and side effects including infections, bleeding, pain
Same as current
Not Provided
Not Provided
 
Routine Follow-up Versus Self-assessment in Medical Abortion
Routine Follow-up Versus Self-assessment of Complete Abortion Following Medical Abortion, Effect on Its Success and Acceptability: a Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Medical Abortion
Other: Home 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.
  • No Intervention: Controls
    Routine follow-up at the clinic 2-3 weeks after the treatment
  • Home self test
    Intervention
    Intervention: Other: Home self assessment of complete medical abortion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
929
July 2013
July 2013   (final data collection date for primary outcome measure)

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).
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Finland,   Norway,   Sweden
 
NCT01487213
WNI1000
Yes
Kristina Gemzell Danielsson, Karolinska Institutet
Karolinska Institutet
  • Ullevaal University Hospital
  • Helsinki University
  • GynMed Clinic, Vienna, Austria
Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD Karolinska Institutet
Karolinska Institutet
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP