Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period

Study Overview
=================
Brief Summary
-----------------
The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.

Official Title
-----------------
Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine questioning at their 36-38 week prenatal appointment or upon admission to labor and delivery are eligible for our study. Exclusion Criteria: Contraindications to the LNG-IUS include: Pregnancy or suspicion of pregnancy, Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity, Postpartum endometritis within the past 3 months, Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear, untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections, acute liver disease or liver tumor, hypersensitivity to any component of the product, known or suspected carcinoma of the breast. Any of these conditions would exclude the patient from our study. Delivery <36 weeks Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery) Cesarean delivery if randomized to IPP or EP placement

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Postplacental<br>Within 10 minutes from delivery of placenta | Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)<br>* Placement of Mirena at given intervals during the postpartum period<br>|
| Experimental: Early Postpartum<br>After 10 minutes from delivery of placenta but within 48hrs from delivery | Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)<br>* Placement of Mirena at given intervals during the postpartum period<br>|
| Experimental: Interval<br>After 6 weeks postpartum | Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)<br>* Placement of Mirena at given intervals during the postpartum period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation Rates of the LNG-IUS when placed postpartum at three time periods | Determine if there is a difference in continuation rates at 6 months between participants who had the LNG-IUS placed at three different time periods: Immediate Postplacental (within 10 minutes from delivery of placenta), Early Postpartum (after 10 minutes but before 48 hours postpartum) , and Interval (after 6 weeks postpartum). | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion rate of the LNG-IUS when placed postpartum at three time periods | Determine if there is a difference in expulsion rates at the three different time periods of placement. | at 3 weeks | 
| Pain at placement | Determine if there is a difference pain as assessed with the Visual Analog Scale at the time of placement of the LNG-IUS at three time period: Immediate Postplacental, Early Postpartum, or Interval. | at 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long-Acting Reversible Contraception, Contraceptive Agents, Therapeutic Uses, Contraceptive Agents, Female, Reproductive Control Agents, Pharmacologic Actions, Levonorgestrel