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Routine Follow-up Versus Self-assessment in Medical Abortion

This study is currently recruiting participants.
Verified December 2011 by Karolinska Institutet
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: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Medical Abortion
 Other: Home self assessment of complete medical abortion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Routine Follow-up Versus Self-assessment of Complete Abortion Following Medical Abortion, Effect on Its Success and Acceptability: a Randomized Controlled Trial

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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%.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1200
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Controls
Routine follow-up at the clinic 2-3 weeks after the treatment
Home self test
Intervention
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487213

Contacts
Contact: Kristina Gemzell-Danielsson, MD, PhD +46851772128 kristina.gemzell@ki.se
Contact: Kevin Sunde-Oppegaard, MD, PhD kevin.s.oppegaard@helse-finnmark.no

Locations
Austria
GynMed Clinic Recruiting
Vienna, Austria
Contact: Christian Fiala, MD, PhD         christian.fiala@aon.at    
Principal Investigator: Christian Fiala, MD, PhD            
Finland
Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital Recruiting
Helsinki, Finland
Contact: Oskari Heikinheimo, MD, PhD         oskari.heikinheimo@helsinki.fi    
Principal Investigator: Oskari Heikinheimo, MD, PhD            
Norway
Faculty of Medicine, University of Oslo and Dept. of Gynaecology, Recruiting
Oslo, Norway
Contact: Erik Qvigstad, MD, PhD         erik.qvigstad@ulleval.no    
Principal Investigator: Erik Qvigstad, MD, PhD            
Sweden
Dept of Obstetrics and Gynecology, Karolinska University Hospital Recruiting
Stockholm, Sweden, SE17176
Principal Investigator: Kristina Gemzell Danielsson, Prof.MD.PhD            
Sponsors and Collaborators
Karolinska Institutet
Ullevaal University Hospital
Helsinki University
GynMed Clinic, Vienna, Austria
Investigators
Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Kristina Gemzell Danielsson, professor, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01487213     History of Changes
Other Study ID Numbers: WNI1000
Study First Received: December 2, 2011
Last Updated: December 6, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
Medical abortion
Termination of pregnancy
Mifepristone
Misoprostol
 Urine hCG
Follow Up
Termination of unwanted pregnancy. Self assessment (follow up) after medical abortion

ClinicalTrials.gov processed this record on June 18, 2013