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 |