Medical Abortion up to 10 Weeks Gestation at Home

Karolinska Institute

Status: Completed

Conditions: Pregnancy Complications; Legally Induced Abortion Without Mention of Complication

Treatments: Procedure: Medical abortion at home

Study type: Observational

Funder types: Other

Identifiers

NCT02191774

Marions 2014 1.2

2013-004749-18 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 273 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

273 participants in 2 patient groups

Gestational length up to 63 days

Description:

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

Treatment:

Procedure: Medical abortion at home

Gestational length 64-70 days

Description:

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

Treatment:

Procedure: Medical abortion at home