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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate | Experimental | Placement within 48 hours of delivery |
|
| Control | Active Comparator | Placement 4-8 weeks after delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel-releasing intrauterine system | Drug | Placement within 48 hours of delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding | Reported any breastfeeding at the final 6 month visit | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| LNG-IUS Expulsion or Removal | Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study | up to 6 months |
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Additional eligibility criteria for entry into the randomized trial, as assessed postpartum
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen Stuart, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Women's Hospital | Chapel Hill | North Carolina | 27599 | United States |
26 women failed entry criteria after delivery. Therefore although 61 were enrolled in the original study cohort, only 35 were randomized and allocated to one of the two treatment arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate | Placement within 48 hours of delivery Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery |
| FG001 | Control | Placement 4-8 weeks after delivery Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics of women allocated to immediate or late LNG-IUS placement after delivery.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate | Placement within 48 hours of delivery Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery |
| BG001 | Control | Placement 4-8 weeks after delivery Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Breastfeeding | Reported any breastfeeding at the final 6 month visit | Posted | Number | participants | 6 months |
|
|
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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 | Immediate | Placement within 48 hours of delivery Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gretchen Stuart | University of North Carolina School of Medicine | 919-962-4880 | gstuart@med.unc.edu |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Participants |
|
|
| Secondary | LNG-IUS Expulsion or Removal | Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study | Posted | Number | participants | up to 6 months |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Control | Placement 4-8 weeks after delivery Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery | 0 | 18 | 0 | 18 |
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |