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Routine Follow-up Versus Self-assessment in Medical Abortion

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ClinicalTrials.gov Identifier: NCT01487213
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : August 7, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Medical Abortion Other: Home self assessment of complete medical abortion

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 929 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487213


Locations
Austria
GynMed Clinic
Vienna, Austria
Finland
Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital
Helsinki, Finland
Norway
Faculty of Medicine, University of Oslo and Dept. of Gynaecology,
Oslo, Norway
Sweden
Dept of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, Sweden, SE17176
Sponsors and Collaborators
Karolinska Institutet
Ullevaal University Hospital
Helsinki University
Gynmed Clinic Vienna
Investigators
Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD Karolinska Institutet
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristina Gemzell Danielsson, professor, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01487213     History of Changes
Other Study ID Numbers: WNI1000
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

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