Better Contraceptive Choices: Immediate or Delayed Insertion of IUD After Second Trimester Abortion - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 3, 2009

Last Updated Date

April 6, 2009

Start Date ^†

June 2009

Current Primary Outcome Measures ^†

Pregnancy rate at one year [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00877344 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Better Contraceptive Choices: Immediate or Delayed Insertion of IUD After Second Trimester Abortion

Official Title ^†

Better Contraception for Marginalized Women: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion

Brief Summary

Hypothesis

More pregnancies will be prevented in women after a second trimester abortion using an IUD placed at the time of the abortion, than by scheduling device placement later, or choosing an alternate method of contraception.

Study Design

Randomized Controlled Trial after their second trimester abortion comparing immediate with delayed insertion of IUD, and a non intervention control group choosing non-intrauterine contraception. Participants choosing an IUD will be randomly assigned to immediate or delayed insertion. The investigators primary outcome is pregnancy rate within one year.

Detailed Description

This Randomized Controlled Trial will be offered to women choosing to have an IUD after an abortion for gestational ages from 12 to 24 weeks, and a non intervention control group offered to all others having abortions at this gestational age. Participants choosing an IUD will be randomly assigned to immediate or delayed insertion. In conjunction with follow up visits and questionnaires, the British Columbia Linked Health Database access will determine pregnancy rate within one year for the two intervention groups and in relation to the various contraceptive choices made by the women not choosing intrauterine contraception. All women will complete surveys at 3, 6 and twelve months on their satisfaction with the contraceptive method chosen and on their satisfaction with study participation.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^†

Pregnancy

Intervention ^†

Procedure: IUD

Study Arms / Comparison Groups

Experimental: Immediate insertion of IUD after 12-24 week abortion
Experimental: Delayed (two to four weeks post abortion) insertion of IUD after 12-24 abortion

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Estimated Enrollment ^†

1372

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Have completed informed consent for an abortion at gestation between 12 weeks zero days and 23 weeks 6 days, and
choosing an IUD for contraception post abortion, and
residents of British Columbia, registered with the Medical Services Plan health care system.
Ability to give informed consent

Exclusion Criteria:

Any contraindications to use of an IUD
- Current untreated PID, chlamydia or gonorrhea,
- Uterine cavity anomalies including fibroids of more than 5 cm, excluding repaired Uterine septum,
- hypersensitivity to Copper or polyethylene or Wilsons Disease
Intention to move from BC within the next year
Intention to conceive within the next year.
Post Randomization Exclusion:
- Uterine Perforation at the time of abortion
- Bleeding of more than 500 cc during abortion or use of non-routine uterotonic agents to manage hemorrhage during abortion or prior to discharge.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Wendy V. Norman, MD

604-918-1134

wvnorman@interchange.ubc.ca

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00877344

Responsible Party

Dr. Wendy V. Norman, University of British Columbia

Secondary IDs ^††

Study Sponsor ^†

University of British Columbia

Collaborators ^††

Women’s Health Research Institute
College Of Family Physicians

Investigators ^†

Principal Investigator:	Wendy V. Norman, Ph.D	University of British Columbia
Study Director:	Brian Fitzsimmons, MD	University of British Columbia
Study Chair:	Lyda Dicus	University of British Columbia

Information Provided By

University of British Columbia

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.