Table 2.
Inclusion and Exclusion Criteria
| Inclusion Criteria - This study will be offered to women at the study sites who meet all of the following criteria: |
|---|
| Have completed informed consent for an abortion over 12 and under 24 weeks gestational age. |
| Have chosen an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion. |
| Are residents of British Columbia registered with the Medical Services Plan health care system. |
| Exclusion Criteria |
| Intention to move from BC within the next year |
| Intention to conceive within the next year |
| Uterine cavity anomalies causing distortion of the endometrial canal including fibroids of more than 5 cm, excluding repaired uterine septum |
| Current untreated PID, Chlamydia, gonorrhea, cervicitis or lower genital tract infection (recent infection is not a contraindication to IUC insertion[35]) |
| Wilson's Disease (if choosing a CuT380-IUC) |
| Undiagnosed abnormal uterine bleeding |
| Known uterine or cervical malignancy or cervical dysplasia |
| Known or suspected progestin-dependent neoplasia, including breast cancer (if choosing a LNG-IUC) |
| Active liver disease or dysfunction (if choosing a LNG-IUC) |
| Actual benign or malignant liver tumours (if choosing a LNG-IUC) |
| 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) |
| Bacterial endocarditis |
| Established immunodeficiency (HIV positivity is not an exclusion unless immunodeficient) |
| Acute malignancies affecting blood or leukemias |
| Recent trophoblastic disease while hCG levels are elevated |
| Currently enrolled in another investigational study |
| Post Randomization Exclusion Criteria |
| Failure to undergo an abortion (ie: participants who elect to continue their index pregnancy at any time subsequent to randomization) |
| Uterine perforation at the time of abortion |
| Bleeding of more than 500 cc during abortion |
| Uterine cavity anomalies as outlined above |