Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians
1 other identifier
interventional
1,180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 6, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedAugust 27, 2013
June 1, 2012
1.2 years
June 4, 2012
August 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
feasibility
Successful completion of abortion without need for unscheduled visits or calls.
3 weeks
Secondary Outcomes (2)
efficacy
3 weeks
acceptability
3 weeks
Study Arms (2)
midwife
EXPERIMENTALGynecological exam and ultrasound performed by midwife, medical abortion service provided by midwife,contraceptive advice provided by midwife. Follow-up visit provided by midwife
Physician
NO INTERVENTIONGynecological exam and ultrasound and contraceptive advice provided by physician. Medical abortion service and follow-up visit provided by midwife
Interventions
Eligibility Criteria
You may qualify if:
- healthy women aged 18-45 with no contraindication to medical abortion
You may not qualify if:
- any medical condition which contraindicates medical abortion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Stockholm, 17177, Sweden
Related Publications (1)
Kopp Kallner H, Gomperts R, Salomonsson E, Johansson M, Marions L, Gemzell-Danielsson K. The efficacy, safety and acceptability of medical termination of pregnancy provided by standard care by doctors or by nurse-midwives: a randomised controlled equivalence trial. BJOG. 2015 Mar;122(4):510-7. doi: 10.1111/1471-0528.12982. Epub 2014 Jul 18.
PMID: 25040643DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristina Gemzell Danielsson, professor
Karolinska Institutet
- PRINCIPAL INVESTIGATOR
Helena Kopp Kallner, MD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 6, 2012
Study Start
April 1, 2011
Primary Completion
June 1, 2012
Study Completion
July 1, 2012
Last Updated
August 27, 2013
Record last verified: 2012-06