Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding
Condition: Postpartum Contraception
Intervention: Levonorgestrel-releasing intrauterine system
Intervention description: Placement within 48 hours of delivery
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their
      infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive
      method postpartum. The investigators will compare the frequency of breastfeeding among women
      receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after
      vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no
      difference in breastfeeding prevalence between the two groups.
    

Eligibility criteria:

        1. Women ages 18-45

          2. Pregnant and equal to or more than 24 weeks of estimated gestational age

          3. States an intent to breastfeed for at least 6 months

          4. States a plan to use the LNG-IUS postpartum

          5. Anticipates a vaginal delivery

          6. HIV negative

          7. Intend to stay in the Chapel Hill area for at least 6 months after birth

          8. No medical or personal conditions which in the judgment of study staff preclude
             participation in the study

          9. Have no allergies to any component of the LNG-IUS

         10. No known uterine anomalies

         11. Fluent in English

         12. No history of ectopic pregnancy

         13. No known or suspected carcinoma of the breast

         14. No known acute liver disease or liver tumor (benign or malignant)

         15. No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear

         16. No active pelvic inflammatory disease

         17. No known hypersensitivity to any component of the LNG-IUS

         18. No genital bleeding of unknown etiology

         19. No history of solid organ transplantation

        Additional eligibility criteria for entry into the randomized trial, as assessed postpartum

          1. No endometritis or chorioamnionitis

          2. Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes)

          3. No fever greater than or equal to 38°C during the intrapartum or postpartum period

          4. Did not receive medications other than pitocin and/or misoprostol to control
             postpartum bleeding

          5. Did not have a documented estimated blood loss of greater than 750mL intrapartum

          6. Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage

          7. Did not have a third or fourth degree laceration at delivery.

          8. The infant must be greater than 35 weeks EGA at birth as determined by physical exam
             at birth

          9. The infant must weigh at least 2727 grams

         10. Must have been a singleton birth

         11. Infant not in the intensive care nursery

         12. The infant has not been diagnosed with a condition which would preclude long term
             feeding