LNG-IUS at 2 Weeks Postpartum

Completed · Phase 4

Conditions studied: Contraception, Malposition of Intrauterine Contraceptive Device

In brief

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.

Key facts

Study ID

NCT02121067

Run by

University of North Carolina, Chapel Hill

People needed

50

Starts

2014-09-01

Expected to finish

2016-06-01

Last updated by the study team

2017-08-24

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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