LNG-IUS at 2 Weeks Postpartum

University of North Carolina, Chapel Hill50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Contraception Malposition of Intrauterine Contraceptive Device

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Desiring a LNG-IUS 2. Postpartum, ages 18-45 who deliver at a gestational age \> 32 weeks, delivery can be via cesarean or vaginal delivery 3. Following a viable, singleton pregnancy 4. Willing to return to UNC for their LNG-IUS insertion and study follow-up 5. Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits 6. Fluent in English or Spanish 7. At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization) Exclusion Criteria: 1. No genital bleeding of unknown etiology 2. No personal history of known or suspected breast carcinoma 3. No 4th degree vaginal laceration at time of delivery 4. No documented uterine rupture during delivery 5. No active liver disease (resolved pre-eclampsia may enroll) 6. No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion 7. No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage 8. No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4 9. Not currently incarcerated 10. No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity 11. No suspected hypersensitivity or contraindication to the LNG-IUS 12. With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study.

Outcomes

Primary Outcomes

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?"

Time frame: 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?

Time frame: Day 14-20 postpartum

Secondary Outcomes

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.