LNG-IUS at 2 Weeks Postpartum

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

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.

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Detailed Description

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Conditions

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Contraception Malposition of Intrauterine Contraceptive Device

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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LNG-IUS placed at 2 weeks postpartum

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

Group Type EXPERIMENTAL

Levonorgestrel Intrauterine System (LNG-IUS)

Intervention Type DRUG

The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled

Interventions

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Levonorgestrel Intrauterine System (LNG-IUS)

The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled

Intervention Type DRUG

Other Intervention Names

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Mirena

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes