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

This study has been completed.
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet Identifier:
First received: June 4, 2012
Last updated: August 25, 2013
Last verified: June 2012
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
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 ]
    Successful completion of abortion without need for unscheduled visits or calls.

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

  • acceptability [ Time Frame: 3 weeks ]
    as assessed by questionnaire

Enrollment: 1180
Study Start Date: April 2011
Study Completion Date: July 2012
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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01612923

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet Identifier: NCT01612923     History of Changes
Other Study ID Numbers: W2010U
Study First Received: June 4, 2012
Last Updated: August 25, 2013

Keywords provided by Karolinska Institutet:
medical abortion

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 28, 2017