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Post Abortion IUD & Recurrent Abortion 2001-2004

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965770
First Posted: August 26, 2009
Last Update Posted: June 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
  Purpose
It has been shown that the immediate insertion of intrauterine devices (IUDs) post-abortion prevents repeat abortions. The researchers hypothesize that providing free IUDs post-abortion will be associated with a lower rate of repeat abortion in a Canadian population. Further, the researchers hypothesize that providing free IUDs post-abortion will be associated with decreased costs for the health care system.

Condition Intervention
Abortion Rate Device: Intrauterine device (IUD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Preventing Repeat Abortion: Is the Immediate Insertion of Intrauterine Devices Post-abortion a Cost-effective Option Associated With Fewer Repeat Abortions? Findings From 2001-2004 Data

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The proportion of repeat abortions at five years from the index abortions. [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • A cost-effectiveness analysis of providing free IUDs to women immediately post-abortion; correlation of repeat and index abortions with obstetrical, demographic and contraceptive history factors. [ Time Frame: 2 months ]

Enrollment: 1101
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IUD
Repeat abortion rate in women receiving IUDs immediately post-abortion
Device: Intrauterine device (IUD)
Women choosing to have an intrauterine device (IUD) inserted immediately post-abortion

Detailed Description:

The researchers intend to demonstrate whether there are statistically significant differences in the rates of repeat abortions between three groups: 1. women choosing to have an intrauterine device (IUD) inserted immediately post-abortion, 2. those choosing to begin oral contraceptives immediately post-abortion, and 3. all other choices for post abortion contraception including those stating an intention to obtain contraceptives at a later time or from an alternate location or to use no contraception. This data will then be used to conduct a cost-effectiveness analysis of health system provision for cost-free IUDs post-abortion.

The researchers will conduct a retrospective observational cohort study by chart review. The researchers propose to review the charts of 600 women undergoing abortions between January 1, 2001 and December 31, 2004 at Kelowna General Hospital's Women's Services Clinic. The researchers will record the following data from each chart: age, parity, gestational age, date of index therapeutic abortion (TA), dates of subsequent TAs, contraception used at the time of the index conception, contraceptive method chosen post-abortion, and outcome of follow-up at two weeks, such as expulsion of IUD. The researchers will also record the recurrent pregnancy rates.

  Eligibility

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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female resident of Interior Health region seeking an abortion
Criteria

Inclusion Criteria:

  • Female resident of Interior Health region seeking an abortion between January 1, 2001 and December 31, 2004

Exclusion Criteria:

  • Women undergoing abortions for fetal genetic abnormalities
  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): NCT00965770


Locations
Canada, British Columbia
Women's Services Clinic, Kelowna General Hospital
Kelowna, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Wendy Norman, Dr. University of British Columbia
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00965770     History of Changes
Other Study ID Numbers: H09-01871
First Submitted: August 24, 2009
First Posted: August 26, 2009
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by University of British Columbia:
abortion
intrauterine device
cost-effectiveness