Medical Abortion up to 10 Weeks Gestation at Home

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT02191774
• Collaborator: (none)
• Enrollment: 273
• Location: 1
• Actual Duration (Months): 87
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Complications; Legally Induced Abortion Without Mention of Complication	Procedure: Medical abortion at home

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 Design

• Study Type: Observational
• Actual Enrollment: 273 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Medical Abortion up to 10 Weeks Gestation at Home
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Gestational length up to 63 days 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	Procedure: Medical abortion at home; Medical abortion using Mifepristone at the clinic followed by Cytotec at home
Gestational length 64-70 days 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	Procedure: Medical abortion at home; Medical abortion using Mifepristone at the clinic followed by Cytotec at home

Outcome Measures

Primary Outcome Measures

1. Number of incomplete abortions [4 weeks after treatment]

   Need for surgical or pharmaceutical intervention

Secondary Outcome Measures

1. Duration of bleeding [4 weeks after treatment]

   Measured by diary and questionnaires

2. Acceptance and satisfaction of treatment [4 weeks after treatment]

   Questionnaires

3. Number of additional visits to the clinic [4 weeks after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Södersjukhuset	Stockholm		Sweden	118 83

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Lena Marions, MD PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lena Marions, Associate professor, senior consultant, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02191774
• Other Study ID Numbers: Marions 2014 1.2; 2013-004749-18
• First Posted: Jul 16, 2014
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Lena Marions, Associate professor, senior consultant, Karolinska Institutet: Medical abortion; Home abortion
• Additional relevant MeSH terms: Pregnancy Complications

Study Results

No Results Posted as of Jun 22, 2022