Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding

Study Overview
=================
Brief 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.

Official Title
-----------------
Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1)

Conditions
-----------------
Postpartum Contraception

Intervention / Treatment
-----------------
* Drug: Levonorgestrel-releasing intrauterine system


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate<br>Placement within 48 hours of delivery | Drug: Levonorgestrel-releasing intrauterine system<br>* Placement within 48 hours of delivery<br>* Other names: Mirena;|
| Active Comparator: Control<br>Placement 4-8 weeks after delivery | Drug: Levonorgestrel-releasing intrauterine system<br>* Placement within 48 hours of delivery<br>* Other names: Mirena;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding | Reported any breastfeeding at the final 6 month visit | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LNG-IUS Expulsion or Removal | Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study | up to 6 months |