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 |
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DOI | https://doi.org/10.1186/ISRCTN19506752 |
Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wendy V. Norman
Scientific
Scientific
200- 1177 West Broadway
Vancouver
V6H 1G3
Canada
Phone | +1 604 761 7767 |
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wendy.norman@ubc.ca |
Study information
Study design | Interventional multisite randomized controlled trial. Randomization by blocking (4) and stratified for parity and study site. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | Not available in web format, please use contact details to request a patient 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 | 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 study start date | 01/04/2010 |
Completion date | 06/04/2015 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | 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) |
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
200- 1177 West Broadway
Vancouver
V6H 1G3
Canada
V6H 1G3
Canada
Sponsor information
University of British Columbia (Canada)
University/education
University/education
Faculty of Medicine
200- 1177 West Broadway
Vancouver
V6H 1G3
Canada
abc@email.com | |
https://ror.org/03rmrcq20 |
Funders
Funder type
Research council
Canadian Institutes of Health Research (CIHR) (Canada) (F09-04035)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Women's Health Research Institute (Canada) (infrastructure support) (F08-05221)
No information available
Bayer Canada (solely by donation of Mirena devices with no financial support, nor input to study design or conduct) (F09-04254)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | protocol | 14/06/2011 | Yes | No | |
Other publications | 12/07/2016 | 28/10/2022 | Yes | No |
Editorial Notes
28/10/2022: Publication reference added.
24/07/2020: No publications found.
31/01/2019: Internal review