LNG-IUS at 2 Weeks Postpartum

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
LNG-IUS placed at 2 weeks postpartum	Levonorgestrel Intrauterine System (LNG-IUS)	Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.	6 months postpartum	A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"
Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.	Day 14-20 postpartum	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?

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.	6 months postpartum	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.