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

Tracking Information

First Received Date ^ICMJE

December 2, 2011

Last Updated Date

December 6, 2011

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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%.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01487213 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Routine Follow-up Versus Self-assessment in Medical Abortion

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Medical Abortion

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1200

Estimated Completion Date

December 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Austria, Finland, Norway, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01487213

Other Study ID Numbers ^ICMJE

WNI1000

Has Data Monitoring Committee

Yes

Responsible Party

Kristina Gemzell Danielsson, Karolinska Institutet

Study Sponsor ^ICMJE

Karolinska Institutet

Collaborators ^ICMJE

Ullevaal University Hospital
Helsinki University
GynMed Clinic, Vienna, Austria

Investigators ^ICMJE

Principal Investigator:

Kristina Gemzell-Danielsson, MD, PhD

Karolinska Institutet

Information Provided By

Karolinska Institutet

Verification Date

December 2011

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

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