| Primary | Use of the LNG-IUS for Contraception | | | Posted | | Number | | participants | | 12 months after cesarean delivery | | | | ID | Title | Description |
|---|
| OG000 | Delayed Insertion Group | Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery | | OG001 | Postplacental Insertion After Cesarean | Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta |
| | | Title | Denominators | Categories |
|---|
| Confirmed use of LNG-IUD | | | | Lost to follow up at 12 months | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Fisher Exact | | 0.35 | | | | | | 2-Sided | | | | | | | | Superiority or Other (legacy) | | |
|
| Secondary | Rates of Expulsion of the LNG-IUS | | | Posted | | Number | | participants | | 12 months after cesarean delivery | | | | ID | Title | Description |
|---|
| OG000 | Delayed Insertion Group | Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery | | OG001 | Postplacental Insertion After Cesarean | Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta |
| |
| Secondary | Perforation Rates | | | Posted | | Number | | participants | | 12 months after cesarean delivery | | | | ID | Title | Description |
|---|
| OG000 | Delayed Insertion Group | Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery | | OG001 | Postplacental Insertion After Cesarean | Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta |
| |
| Secondary | Satisfaction With LNG-IUS | We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question. | Analysis only done on subject completing six-month visit | Posted | | Number | | participants | | 6 months after cesarean delivery | | | | ID | Title | Description |
|---|
| OG000 | Delayed Insertion Group | Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery | | OG001 | Postplacental Insertion After Cesarean | Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta |
| |
| Secondary | Satisfaction With LNG-IUS | We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question. | Analysis only done on subjects completing 12-month visit | Posted | | Number | | participants | | 12 months after cesarean delivery | | | | ID | Title | Description |
|---|
| OG000 | Delayed Insertion Group | Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery | | OG001 | Postplacental Insertion After Cesarean | Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta |
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