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Trials / Completed

CompletedNCT02191774

Medical Abortion up to 10 Weeks Gestation at Home

Status
Completed
Phase
Study type
Observational
Enrollment
273 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREMedical abortion at homeMedical abortion using Mifepristone at the clinic followed by Cytotec at home

Timeline

Start date
2014-09-01
Primary completion
2021-12-01
Completion
2021-12-01
First posted
2014-07-16
Last updated
2022-06-22

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02191774. Inclusion in this directory is not an endorsement.

Medical Abortion up to 10 Weeks Gestation at Home (NCT02191774) · Clinical Trials Directory