Contraception, Malposition of Intrauterine Contraceptive Device
Conditions
Keywords
postpartum, contraception, intrauterine device, intrauterine system, mirena, uterine involution
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.
Interventions
The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled
Sponsors
Society of Family Planning
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum. | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months. | 6 months postpartum | Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LNG-IUS Placed at 2 Weeks Postpartum Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | LNG-IUS Placed at 2 Weeks Postpartum |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Age, Continuous | 30 years |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
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?
Time frame: Day 14-20 postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LNG-IUS Placed at 2 Weeks Postpartum | 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 Participants |
Primary
Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
A dichotomous, yes/no answer to the following question Would you recommend Mirena placement at two-weeks postpartum to a friend?
Time frame: 6 months postpartum
Population: Of the 50 participants who enrolled, only 43 were available at 6 months postpartum to provide data for the first primary outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LNG-IUS Placed at 2 Weeks Postpartum | Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum. | 40 Participants |
Secondary
Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.
Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.
Time frame: 6 months postpartum
Population: Of the 50 participants who enrolled and had an LNG-IUS placed at 2 weeks postpartum, only 43 were available at 6 months postpartum to provide data for expulsion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LNG-IUS Placed at 2 Weeks Postpartum | Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months. | 2 Participants |