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

Sponsors and Collaborators:	University of British Columbia Women’s Health Research Institute College Of Family Physicians
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00877344

Purpose

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.

Condition	Intervention	Phase
Pregnancy	Procedure: IUD	Phase IV

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Better Contraception for Marginalized Women: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

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

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 ]

Estimated Enrollment:	1372
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Immediate insertion of IUD after 12-24 week abortion	Procedure: IUD Immediate or Delayed Timing of insertion for a copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, delayed insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.
2: Experimental Delayed (two to four weeks post abortion) insertion of IUD after 12-24 abortion	Procedure: IUD Immediate or Delayed Timing of insertion for a copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, delayed insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877344

Contacts

Contact: Wendy V. Norman, MD

604-918-1134

wvnorman@interchange.ubc.ca

Locations

Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada
Elizabeth Bagshaw Women's Clinic
Vancouver, British Columbia, Canada
Kelowna General Hospital Women's Services Clinic
Kelowna, British Columbia, Canada

Sponsors and Collaborators

University of British Columbia

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

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. Wendy V. Norman )
Study ID Numbers:	H09-00363
Study First Received:	April 3, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00877344 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Pregnancy
IUD
abortion
contraception

Study placed in the following topic categories:

Contraceptive Agents
Copper

ClinicalTrials.gov processed this record on May 07, 2009