Better Contraceptive Choices for Marginalized Women: A Randomised Controlled Trial Comparing Immediate or Interval Insertion of Intrauterine Contraception after Second Trimester Abortion

niversity of British Columbia (Canada)0 个研究点目标入组 716 人开始时间: 2010年6月15日最近更新: 2022年11月7日

适应症

试验速览

•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

•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

发起方

niversity of British Columbia (Canada)