Phase 4
N=50
LNG-IUS at 2 Weeks Postpartum
Contraception · Malposition of Intrauterine Contraceptive Device
Bottom Line
View on ClinicalTrials.gov: NCT02121067 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum. — 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levonorgestrel Intrauterine System (LNG-IUS) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum. |
40 | — |
| PRIMARY Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period. |
50 | — |
| SECONDARY Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months. |
2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02121067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.