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Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians

This study is currently recruiting participants.
Verified June 2012 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01612923
First received: June 4, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

The physical examination before an abortion is usually performed by a physician. However, in many countries access to physicians is limited. To increase access to safe abortion this study wishes to examine if midlevel providers such as specially trained midwives can provide safe abortion services. Midwives in study were specially trained to perform early pregnancy ultrasound and if needed to consult a physician. The midwife then provided the abortion service as well as the contraceptive advice. Women were randomized to receive the service from a midwife or a physician.


Condition Intervention Phase
Medical Abortion
 Other: Midwife
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • feasibility [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Successful completion of abortion without need for unscheduled visits or calls.


Secondary Outcome Measures:
  • efficacy [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    complete uterine evacuation without the need for further medical or surgical intervention

  • acceptability [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    as assessed by questionnaire


Estimated Enrollment: 1250
Study Start Date: April 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: midwife
Gynecological exam and ultrasound performed by midwife, medical abortion service provided by midwife,contraceptive advice provided by midwife. Follow-up visit provided by midwife
 Other: Midwife
gynecological exam and ultrasound and contraceptive advice provided by midwife
No Intervention: Physician
Gynecological exam and ultrasound and contraceptive advice provided by physician. Medical abortion service and follow-up visit provided by midwife

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy women aged 18-45 with no contraindication to medical abortion

Exclusion Criteria:

  • any medical condition which contraindicates medical abortion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612923

Contacts
Contact: Kristina Gemzell Danielsson, professor kristina.gemzell@ki.se
Contact: Helena Kopp Kallner, MD helena.kopp-kallner@ds.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17177
Sponsors and Collaborators
Kristina Gemzell Danielsson
Investigators
Principal Investigator: Kristina Gemzell Danielsson, professor Karolinska Institutet
Principal Investigator: Helena Kopp Kallner, MD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01612923     History of Changes
Other Study ID Numbers: W2010U
Study First Received: June 4, 2012
Last Updated: June 4, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
abortion
medical abortion

ClinicalTrials.gov processed this record on May 19, 2013