Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Wendy V. Norman


Contact details

200- 1177 West Broadway
V6H 1G3
+1 604 761 7767

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Contraceptive management; Intrauterine contraceptive devices


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



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment


Trial participating centre

200- 1177 West Broadway
V6H 1G3

Sponsor information


University of British Columbia (Canada)

Sponsor details

Faculty of Medicine
200- 1177 West Broadway
V6H 1G3

Sponsor type




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, IRSC

Funding Body Type

government organisation

Funding Body Subtype

National government



Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


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

Basic results (scientific)

Publication list

2011 protocol in

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

24/07/2020: No publications found. 31/01/2019: Internal review