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
• 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
• 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

Related Conditions & MeSH terms

• Legally Induced Abortion Without Mention of Complication
• Pregnancy Complications

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