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. 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
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
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
-
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.