Medical Abortion up to 10 Weeks Gestation at Home

Completed

• Conditions: Legally Induced Abortion Without Mention of Complication; Pregnancy Complications
• Interventions: Procedure: Medical abortion at home

• Registration Number: NCT02191774
• Lead Sponsor: Karolinska Institutet

Brief 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.

Study Timeline

• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Study Start: 2014-09
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 273

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gestational length up to 63 days	Medical abortion at home	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
Gestational length 64-70 days	Medical abortion at home	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

Primary Outcome Measures

Name	Time	Method
Number of incomplete abortions	4 weeks after treatment	Need for surgical or pharmaceutical intervention

Secondary Outcome Measures

Name	Time	Method
Acceptance and satisfaction of treatment	4 weeks after treatment	Questionnaires
Duration of bleeding	4 weeks after treatment	Measured by diary and questionnaires
Number of additional visits to the clinic	4 weeks after treatment

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden