Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes
Overview
- Phase
- Phase 4
- Intervention
- Levonorgestrel Intrauterine System (LNG-IUS)
- Conditions
- Contraception
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Arms & Interventions
LNG-IUS placed at 2 weeks postpartum
Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Intervention: Levonorgestrel Intrauterine System (LNG-IUS)
Outcomes
Primary Outcomes
Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
Time Frame: 6 months postpartum
A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"
Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.
Time Frame: Day 14-20 postpartum
Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?
Secondary Outcomes
- Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.(6 months postpartum)