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NCT02191774 Clinical Trial

Medical Abortion up to 10 Weeks Gestation at Home

Pregnancy Complications Clinical Trial

Official title:
Medical Abortion up to 10 Weeks Gestation at Home

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02191774
Other study ID # Marions 2014 1.2
Secondary ID 2013-004749-18
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date December 2021

Study information
Verified date June 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 273
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Medical abortion at home
Medical abortion using Mifepristone at the clinic followed by Cytotec at home

Locations
Country Name City State
Sweden Södersjukhuset Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of incomplete abortions Need for surgical or pharmaceutical intervention 4 weeks after treatment
Secondary Duration of bleeding Measured by diary and questionnaires 4 weeks after treatment
Secondary Acceptance and satisfaction of treatment Questionnaires 4 weeks after treatment
Secondary Number of additional visits to the clinic 4 weeks after treatment
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