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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNG-IUS placed at 2 weeks postpartum | Experimental | Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG-IUS) | Drug | The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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?" | 6 months 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. | 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? | Day 14-20 postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew L Zerden, MD, MPH | UNCH | Principal Investigator |
| Gretchen S Stuart, MD | University of North Carolina, Chapel Hill | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27554014 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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?" | Of the 50 participants who enrolled, only 43 were available at 6 months postpartum to provide data for the first primary outcome. | Posted | Count of Participants | Participants | 6 months postpartum |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Zerden, MD, MPH | University of North Carolina | 6179352394 | mzerden@gmail.com |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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|
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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? | Posted | Count of Participants | Participants | Day 14-20 postpartum |
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|
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| 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. | 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. | Posted | Count of Participants | Participants | 6 months postpartum |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |