NCT00965770

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,101

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

August 24, 2009

Last Update Submit

May 1, 2018

Conditions

Abortion Rate

Keywords

abortionintrauterine devicecost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • The proportion of repeat abortions at five years from the index abortions.

    5 years

Secondary Outcomes (1)

  • 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

Study Arms (1)

IUD

Repeat abortion rate in women receiving IUDs immediately post-abortion

Device: Intrauterine device (IUD)

Interventions

Intrauterine device (IUD)DEVICE

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

IUD

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female resident of Interior Health region seeking an abortion

You may qualify if:

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

You may not qualify if:

  • Women undergoing abortions for fetal genetic abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Services Clinic, Kelowna General Hospital

Kelowna, British Columbia, Canada

Location

MeSH Terms

Interventions

Intrauterine Devices

Intervention Hierarchy (Ancestors)

Contraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Officials

  • Wendy Norman, Dr.

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 26, 2009

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

CA(1)