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LNG-IUS at 2 Weeks Postpartum

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception; Malposition of Intrauterine Contraceptive Device

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

Phase: Phase 4

Status: Recruiting

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Matthew L Zerden, MD, MPH, Principal Investigator, Affiliation: UNCH
Gretchen S Stuart, MD, Study Director, Affiliation: University of North Carolina, Chapel Hill

Overall contact:
Matthew L Zerden, MD, MPH, Phone: 919-843-5633, Email: Matthew_Zerden@med.unc.edu

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.

Clinical Details

Official title: Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: To report the acceptability of receiving an LNG-IUS two-weeks postpartum.

Secondary outcome:

To estimate the expulsion rate (complete or partial) at six months of LNG-IUS placed at two-weeks postpartum.

To assess the pain experience of LNG-IUS insertion.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Locations and Contacts

Matthew L Zerden, MD, MPH, Phone: 919-843-5633, Email: Matthew_Zerden@med.unc.edu

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States; Recruiting
Matthew L. Zerden, MD, MPH, Phone: 919-843-5633, Email: Matthew_Zerden@med.unc.edu
Gretchen S. Stuart, MD, Phone: 919-843-5633, Email: gstuart@med.unc.edu
Matthew L Zerden, MD, MPH, Principal Investigator
Additional Information

Starting date: September 2014
Last updated: April 6, 2015

Page last updated: August 23, 2015

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