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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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The main objective of the study is to compare use, in a randomised controlled trial, of the the copper IUD if inserted immediately after completion of a second trimester medical abortion, to standard care with insertion 3-4 or more weeks after abortion at community health centres.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate group: | Experimental | The Copper Intrauterine device will be inserted within 24 hours of the expulsion of the fetus and placenta or after surgical evacuation for placental remains, and prior to discharge from the facility. |
|
| Delayed Group | No Intervention | The Copper Intrauterine device will be inserted at a local community health centre 14-28 days after discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper Intrauterine device | Device | Immediate insertion of the copper intrauterine device after completion of abortion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of the copper IUD | Number of women using the IUD | 6 weeks after second trimester abortion |
| Insertion of the IUD | Number of IUD insertions | 6 weeks after second trimester abortion |
| Measure | Description | Time Frame |
|---|---|---|
| Use of the IUD at 3 months post-abortion | Number of women using the IUD | 3 months after second trimester medical abortion |
| Use of the IUD at 6 months post-abortion | Number of women using the IUD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Constant, PhD | University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groote Schuur Hospital | Cape Town | Western Province | 7925 | South Africa |
Participant data will be made available from an institutional repository
Data will become available following successful publication of findings - Expected date December 2020. No cut-off date
Through application to lead investigator
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| ID | Term |
|---|---|
| D007435 | Intrauterine Devices, Copper |
| ID | Term |
|---|---|
| D007436 | Intrauterine Devices, Medicated |
| D007434 | Intrauterine Devices |
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
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| 6 months after second trimester medical abortion |
| Spontaneous expulsion of the IUD | Number of full and partial expulsions | 6 weeks post-abortion |
| Spontaneous expulsion of the IUD | Number of full and partial expulsions | Between 6 weeks and 3 months post abortion |
| Spontaneous expulsion of the IUD | Number of full and partial expulsions | Between 3 and 6 months post abortion |
| Removal of IUD and associated factors | Number of removals | within 3 and 6 months post-abortion |
| Abortion-related and IUD-related complications | Number of complications | within 3 months post-abortion |
| Women's satisfaction and acceptability of the IUD | 5 point scales | Reported at 3 and 6 months post-abortion |
| Recurrent pregnancy | Number of recurrent pregnancies | At 6 months post-abortion |
| D004864 | Equipment and Supplies |