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

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ClinicalTrials.gov Identifier: NCT01612923
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : August 27, 2013
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet

Brief Summary:
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 or disease Intervention/treatment Phase
Medical Abortion Other: Midwife Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians
Study Start Date : April 2011
Primary Completion Date : June 2012
Study Completion Date : July 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. feasibility [ Time Frame: 3 weeks ]
    Successful completion of abortion without need for unscheduled visits or calls.


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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612923


Locations
Sweden
Karolinska University Hospital
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01612923     History of Changes
Other Study ID Numbers: W2010U
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: June 2012

Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
abortion
medical abortion

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs