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

Medical Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612923
• Other study ID #: W2010U
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2012
• Last updated: August 25, 2013
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: June 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1180
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• any medical condition which contraindicates medical abortion

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Other:
• Midwife
gynecological exam and ultrasound and contraceptive advice provided by midwife

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Kristina Gemzell Danielsson

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility	Successful completion of abortion without need for unscheduled visits or calls.	3 weeks	Yes
Secondary	efficacy	complete uterine evacuation without the need for further medical or surgical intervention	3 weeks	Yes
Secondary	acceptability	as assessed by questionnaire	3 weeks	No