Contraceptive management
Conditions
Interventions
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 dev
Sponsors
University of British Columbia (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada
Outcome results
None listed