Medical Abortion up to 10 Weeks Gestation at Home

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Medical Abortion up to 10 Weeks Gestation at Home

Conditions
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Pregnancy Complications, Legally Induced Abortion Without Mention of Complication

Intervention / Treatment
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* Procedure: Medical abortion at home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Requesting and eligible for medical abortion Confirmed intrauterine pregnancy Gestational length no more than 70 days Hemoglobin over 100g/l Exclusion Criteria: Anemia Contraindication to mifepristone (steroid-dependant cancer, porphyria) Breast feeding Advanced pregnancy (>70 days) Known liver disease Bleeding disorder Arterial hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gestational length up to 63 days<br>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 | Procedure: Medical abortion at home<br>* Medical abortion using Mifepristone at the clinic followed by Cytotec at home<br>|
| Gestational length 64-70 days<br>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 | Procedure: Medical abortion at home<br>* Medical abortion using Mifepristone at the clinic followed by Cytotec at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of incomplete abortions | Need for surgical or pharmaceutical intervention | 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of bleeding | Measured by diary and questionnaires | 4 weeks after treatment | 
| Acceptance and satisfaction of treatment | Questionnaires | 4 weeks after treatment | 
| Number of additional visits to the clinic |  | 4 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical abortion, Home abortion