LNG-IUS at 2 Weeks Postpartum
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | September 2014 |
| End Date: | January 2016 |
| Contact: | Matthew L Zerden, MD, MPH |
| Email: | Matthew_Zerden@med.unc.edu |
| Phone: | 919-843-5633 |
Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes
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.
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.
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.
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