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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004749-18 | EudraCT Number |
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Medical abortion performed in the womens home has shown to be safe and acceptable up to 9 weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of gestation.
The study will include 600 women opting for medical abortion. Women wanting to perform the last part of the abortion in their homes will be invited to participate. 300 women with a pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation length between 64 and 70 days of gestation. The primary endpoints will be number of patients with an incomplete abortion, with a need for surgical or pharmaceutical intervention.
Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method and number of additional visits to the clinic/facility.
The study will be performed in five abortion clinics in Sweden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gestational length up to 63 days | Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later |
| |
| Gestational length 64-70 days | Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical abortion at home | Procedure | Medical abortion using Mifepristone at the clinic followed by Cytotec at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of incomplete abortions | Need for surgical or pharmaceutical intervention | 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of bleeding | Measured by diary and questionnaires | 4 weeks after treatment |
| Acceptance and satisfaction of treatment | Questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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Women with an unwanted pregnancy opting for medical abortion
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| Name | Affiliation | Role |
|---|---|---|
| Lena Marions, MD PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | 118 83 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36933004 | Derived | Podolskyi V, Gemzell-Danielsson K, Maltzman LL, Marions L. Effectiveness and acceptability of home use of misoprostol for medical abortion up to 10 weeks of pregnancy. Acta Obstet Gynecol Scand. 2023 May;102(5):541-548. doi: 10.1111/aogs.14549. Epub 2023 Mar 18. |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 4 weeks after treatment |
| Number of additional visits to the clinic | 4 weeks after treatment |