LNG-IUS at 2 Weeks Postpartum

Study Overview
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Brief Summary
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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.

Official Title
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Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes

Conditions
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Contraception, Malposition of Intrauterine Contraceptive Device

Intervention / Treatment
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* Drug: Levonorgestrel Intrauterine System (LNG-IUS)


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

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LNG-IUS placed at 2 weeks postpartum<br>Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum | Drug: Levonorgestrel Intrauterine System (LNG-IUS)<br>* The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled<br>* Other names: Mirena;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum. | A dichotomous, yes/no answer to the following question Would you recommend Mirena placement at two-weeks postpartum to a friend? | 6 months postpartum | 
| Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period. | Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion? | Day 14-20 postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months. | Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix. | 6 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum, contraception, intrauterine device, intrauterine system, mirena, uterine involution