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| ID | Type | Description | Link |
|---|---|---|---|
| MA1310CN | Other Identifier | company internal |
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To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h) |
| |
| Group 2 | Copper IUDs with different shape and with or without drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUS (Mirena, BAY86-5028) | Drug | LNG-IUS once inserted will be effective for 5 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion | The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day. | Months 4 to 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual bleeding intensity | It will be captured by patient dairy and measured by subjective scale as below.
| up to 6 months |
| Abortion related bleeding days |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects should go through the surgical abortion should meet both inclusion and exclusion criteria. And they are willing to sign an informed consent. And all recruitment should be conducted after the decision of treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29298525 | Derived | Chen X, Li Q, Wang X, Chen J, Lv W, Shi B, Wang H, Luo J, Li J. Bleeding pattern difference between levonorgestrel intrauterine system and copper intrauterine devices inserted immediately post-abortion: a multicenter, prospective, observational cohort study in Chinese women. Curr Med Res Opin. 2018 May;34(5):873-880. doi: 10.1080/03007995.2017.1421919. Epub 2018 Feb 7. |
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| Copper-IUD | Device | Copper-IUD once inserted will be effective for more than 10 years. |
|
|
| up to 1 month |
| Time to the first menstrual bleeding following abortion | This data will be calculated by days | up to 2 months |
| Participants continuation rates of Mirena and Cu-IUD | up to 6 months |
| Reasons for discontinuation of Mirena and Cu-IUD | It will be calculated by percentage | Up to 6 months |
| Participants satisfaction rates of Mirena and Cu-IUD | It will be captured by satisfaction scale as below.
| Up to 6 months |
| Percentage of participants with adverse events | Adverse events included: Pelvic inflammatory disease, Expulsion and Others.) | Up to 6 months |
| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D007435 | Intrauterine Devices, Copper |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007436 | Intrauterine Devices, Medicated |
| D007434 | Intrauterine Devices |
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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