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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Medical abortion at home | Medical 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.