LNG-IUS at 2 Weeks Postpartum
Condition: Contraception; Malposition of Intrauterine Contraceptive Device
Intervention: Levonorgestrel Intrauterine System (LNG-IUS)
Intervention description: The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postpartum; contraception; intrauterine device; intrauterine system; mirena; uterine involution

Summary:

      This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for
      contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides
      contraception for 5 years with excellent effectiveness. Women enrolled in this study will
      only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants
      will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for
      satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months
      postpartum, and participants will be able to keep their LNG-IUS following study completion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Desiring a LNG-IUS

          2. Postpartum, ages 18-45 who deliver at a gestational age > 32 weeks, delivery can be
             via cesarean or vaginal delivery

          3. Following a viable, singleton pregnancy

          4. Willing to return to UNC for their LNG-IUS insertion and study follow-up

          5. Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3
             visits

          6. Fluent in English or Spanish

          7. At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)

        Exclusion Criteria:

          1. No genital bleeding of unknown etiology

          2. No personal history of known or suspected breast carcinoma

          3. No 4th degree vaginal laceration at time of delivery

          4. No documented uterine rupture during delivery

          5. No active liver disease (resolved pre-eclampsia may enroll)

          6. No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion

          7. No history of postpartum endometritis treated with antibiotics or a postpartum
             readmission for a dilation and curettage

          8. No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical
             Eligibility Criteria (MEC) category 3 or 4

          9. Not currently incarcerated

         10. No known congenital or acquired uterine anomaly, including fibroids that distort the
             uterine cavity

         11. No suspected hypersensitivity or contraindication to the LNG-IUS

         12. With any other condition or circumstance that the PI determines could cause an adverse
             event or interfere with completing the study.