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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00965770
Other study ID # H09-01871
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 2011
Est. completion date December 2011

Study information

Verified date May 2018
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1101
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Intrauterine device (IUD)
Women choosing to have an intrauterine device (IUD) inserted immediately post-abortion

Locations

Country Name City State
Canada Women's Services Clinic, Kelowna General Hospital Kelowna British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of repeat abortions at five years from the index abortions. 5 years
Secondary 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. 2 months