Better Contraceptive Choices: Should your intrauterine contraceptive be put in when you have an abortion over 12 weeks gestation, or a month afterwards?
| ISRCTN | ISRCTN19506752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19506752 |
| Protocol serial number | N/A |
| Sponsor | University of British Columbia (Canada) |
| Funders | Canadian Institutes of Health Research (CIHR) (Canada) (F09-04035), Women's Health Research Institute (Canada) (infrastructure support) (F08-05221), Bayer Canada (solely by donation of Mirena devices with no financial support, nor input to study design or conduct) (F09-04254) |
- Submission date
- 20/05/2010
- Registration date
- 15/06/2010
- Last edited
- 28/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
200- 1177 West Broadway
Vancouver
V6H 1G3
Canada
| Phone | +1 604 761 7767 |
|---|---|
| wendy.norman@ubc.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional multisite randomized controlled trial. Randomization by blocking (4) and stratified for parity and study site. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Costs and cost effectiveness |
| Completion date | 06/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 716 |
| Key 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 |
| Key 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. Wilsons 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 |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 06/04/2015 |
Locations
Countries of recruitment
- Canada
Study participating centre
V6H 1G3
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/06/2011 | Yes | No | |
| Other publications | 12/07/2016 | 28/10/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/10/2022: Publication reference added.
24/07/2020: No publications found.
31/01/2019: Internal review