An observational study in Pregnancy Complications and Legally Induced Abortion Without Mention of Complication, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Karolinska Institutet · Observational
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.
437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.
This study's enrollment of 273 is below the median of 320 across 205 observational studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with an unwanted pregnancy opting for medical abortion
Exclusion Criteria:
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
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
Medical abortion using Mifepristone at the clinic followed by Cytotec at home
Number of incomplete abortions
Need for surgical or pharmaceutical intervention
Time frame: 4 weeks after treatment
Duration of bleeding
Measured by diary and questionnaires
Time frame: 4 weeks after treatment
Acceptance and satisfaction of treatment
Questionnaires
Time frame: 4 weeks after treatment
Number of additional visits to the clinic
Time frame: 4 weeks after treatment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet