Clinical trial NCT02121067: LNG-IUS at 2 Weeks Postpartum
Official title: Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Malposition of Intrauterine Contraceptive Device
Keywords: postpartum
contraception
intrauterine device
intrauterine system
mirena
uterine involution
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2014-04-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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:

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.

Primary outcomes:
measure: Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
timeFrame: 6 months postpartum
measure: Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.
timeFrame: Day 14-20 postpartum
Secondary outcomes:
measure: Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNCH
name: Matthew L Zerden, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Gretchen S Stuart, MD
role: STUDY_DIRECTOR
References:
citation: Zerden ML, Stuart GS, Charm S, Bryant A, Garrett J, Morse J. Two-week postpartum intrauterine contraception insertion: a study of feasibility, patient acceptability and short-term outcomes. Contraception. 2017 Jan;95(1):65-70. doi: 10.1016/j.contraception.2016.08.005. Epub 2016 Aug 20.