LNG-IUS at 2 Weeks Postpartum

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Society of Family Planning
• Treatments: Levonorgestrel

Criteria

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.