Condition category
Pregnancy and Childbirth
Date applied
20/05/2010
Date assigned
15/06/2010
Last edited
13/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.bcc4me.ca

Contact information

Type

Scientific

Primary contact

Dr Wendy V. Norman

ORCID ID

Contact details

200- 1177 West Broadway
Vancouver
V6H 1G3
Canada
+1 604 761 7767
wendy.norman@ubc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Better Contraceptive Choices for Marginalized Women: A Randomised Controlled Trial Comparing Immediate or Interval Insertion of Intrauterine Contraception after Second Trimester Abortion

Acronym

Study hypothesis

We hypothesize that intrauterine contraception (IUC) placed immediately after second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.

Ethics approval

The University of British Columbia, Children's and Women's Hospital Research Ethics Board (REB) approved on the 13th of April 2010 (ref: UBC Study ID: H10-00306)

Study design

Interventional multisite randomized controlled trial. Randomization by blocking (4) and stratified for parity and study site.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Contraceptive management; Intrauterine contraceptive devices

Intervention

To women seeking a therapeutic abortion in their second trimester of pregnancy (over 12 weeks gestation) who are interested in intrauterine contraception, we offer a choice between two leading IUC devices currently available in Canada: LNG-IUC (containing 52 mg levonorgestrel, “Mirena Intrauterine System”, Bayer Inc, Toronto, Ont.) and CuT380-IUC (a T-shaped IUC offering 380mm2 surface area of copper, “FlexiT380 (+)”, Prosan International, BV).

The total duration of follow up is 5 years from the date of IUC insertion.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pregnancy rate at one year among women randomized to immediate insertion compared to women randomized to a planned insertion at 4 weeks (“interval insertion”) for each of the two leading IUC devices.
As many women randomized to an interval insertion will never have an IUC inserted, a real life condition for this current standard of care, we will analyse pregnancy rates based upon those randomized to each group, rather than upon those who insert an IUC. In this way we will analyse by “intention to treat” rather than by treatment received. Thus our primary outcome will reflect real life conditions and the true effectiveness of a health care delivery change to prevent unintended pregnancies (immediate insertions of IUC versus the current standard of planned interval insertions).

Secondary outcome measures

1. Costs and cost effectiveness
2. Rates of loss to follow up
3. Adverse events (such as infection or perforation: anticipated at under 1%)
4. Expulsion
5. Continuation of method
6. Satisfaction with IUC chosen and with insertion timing assigned
These outcomes will be assessed initially at one year, and through questionnaires in this study and administrative data base access in subsequent studies, annually during the 5 year device effectiveness period.

Overall trial start date

01/04/2010

Overall trial end date

06/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

This study will be offered to all women who present at the study sites meeting all of the following criteria:
1. Have completed informed consent for an abortion over 12 and under 24 weeks gestational age
2. Have chosen an IUC (either LNG-IUS or CuT380-IUD) for contraception post abortion
3. Are residents of British Columbia (BC) registered with the Medical Services Plan health care system
4. Are able to give informed consent
5. No age limits. Women ot girls of any age, fulfilling the above criteria will be eligibile

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

716 women; 358 (175-Mirena IUS & 183-Copper) recruited to each arm: immediate insertion vs planned interval insertion. (Amended on 13/03/2012: participant enrollment completed)

Participant exclusion criteria

1. Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC:
1.1. Uterine cavity anomalies causing distortion of the endometrial canal including fibroids of > 5 cm, excluding repaired Uterine septum
1.2. Current untreated PID, Chlamydia, gonorrhea, cervicitis or lower genital tract infection
1.3. Wilson’s Disease (if choosing a CuT380-IUC)
1.4. Undiagnosed abnormal uterine bleeding
1.5. Known uterine or cervical malignancy or cervical dysplasia
1.6. Known or suspected progestin-dependent neoplasia, including breast cancer (if choosing a LNG-IUC)
1.7. Active liver disease or dysfunction (if choosing a LNG-IUC)
1.8. Actual benign or malignant liver tumours (if choosing a LNG-IUC)
1.9. Hypersensitivity to levonorgestrel or any of the other ingredients in the formulation or component of the container components of MIRENA (if choosing a LNG-IUC)
1.10. Current bacterial endocarditis
1.11. Established immunodeficiency
1.12. Acute malignancies affecting blood or leukemias
1.13. Recent trophoblastic disease while hCG levels are elevated
2. Intention to move from BC within the next year
3. Intention to conceive within the next year
4. Post Randomization Exclusion:
4.1. Uterine perforation at the time of abortion
4.2. Bleeding of more than 500 cc during abortion
4.3. Any of the above exclusions detected at the time of abortion

Recruitment start date

01/04/2010

Recruitment end date

06/04/2015

Locations

Countries of recruitment

Canada

Trial participating centre

200- 1177 West Broadway
Vancouver
V6H 1G3
Canada

Sponsor information

Organisation

University of British Columbia (Canada)

Sponsor details

Faculty of Medicine
200- 1177 West Broadway
Vancouver
V6H 1G3
Canada

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) (F09-04035)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Funder name

Women's Health Research Institute (Canada) (infrastructure support) (F08-05221)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bayer Canada (solely by donation of Mirena devices with no financial support, nor input to study design or conduct) (F09-04254)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21672213

Publication citations

  1. Protocol

    Norman WV, Kaczorowski J, Soon JA, Brant R, Bryan S, Trouton KJ, Dicus L, Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial., Trials, 2011, 12, 149, doi: 10.1186/1745-6215-12-149.

Additional files

Editorial Notes