Medical Abortion up to 10 Weeks Gestation at Home

June 21, 2022 updated by: Lena Marions, Karolinska Institutet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 118 83
        • Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with an unwanted pregnancy opting for medical abortion

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of incomplete abortions
Time Frame: 4 weeks after treatment
Need for surgical or pharmaceutical intervention
4 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of bleeding
Time Frame: 4 weeks after treatment
Measured by diary and questionnaires
4 weeks after treatment
Acceptance and satisfaction of treatment
Time Frame: 4 weeks after treatment
Questionnaires
4 weeks after treatment
Number of additional visits to the clinic
Time Frame: 4 weeks after treatment
4 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Marions 2014 1.2
  • 2013-004749-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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