LNG-IUS at 2 Weeks Postpartum

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: Malposition of Intrauterine Contraceptive Device; Contraception

Treatments: Drug: Levonorgestrel Intrauterine System (LNG-IUS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02121067

14-0202

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

LNG-IUS placed at 2 weeks postpartum

Experimental group

Description:

Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum

Treatment:

Drug: Levonorgestrel Intrauterine System (LNG-IUS)