Midlevel Versus Physician-provided Medical Abortion in the Second Trimester
NCT ID: NCT04181541
Last Updated: 2021-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
245 participants
INTERVENTIONAL
2020-02-17
2021-03-03
Brief Summary
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Detailed Description
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The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system (WHO abortion guidelines). Training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct second trimester aspiration abortions is proposed as a way to increase women's access to safe abortion procedures and has been highlighted by the WHO as an area in which rigorous research is needed (WHO task-sharing guidelines).
The investigators seek to conduct a comparative study of patients undergoing second trimester medical abortion provided by either physicians or nurse midwives.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Women receiving abortion care by physicians
Patients who receive second trimester medical abortion care from a physician.
Provider type: Physicians
In this cohort, women will receive second trimester medical abortion care from physicians
Women receiving abortion care from midlevel providers
Patients who receive second trimester medical abortion care from a midlevel provider.
Provider type: Midlevel Providers
In this cohort, women will receive second trimester medical abortion care from midlevel providers.
Interventions
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Provider type: Physicians
In this cohort, women will receive second trimester medical abortion care from physicians
Provider type: Midlevel Providers
In this cohort, women will receive second trimester medical abortion care from midlevel providers.
Eligibility Criteria
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Inclusion Criteria
* Intrauterine pregnancy with confirmed gestational age \>13 weeks and \<20 weeks
* Presenting for induced abortion at Michu Clinic
* Speaker of Amharic or Oromo
Exclusion Criteria
* Gestational age \<13 or \>20 weeks
* Adolescents aged less than 16 years
* Women with an allergy to or contraindications to mifepristone or misoprostol
* Women with a history of more than one previous hysterotomy
* Women seeking treatment for incomplete abortion, intrauterine fetal demise, or postabortion care
* Women with chronic hypertension or adrenal failure
* Women on chronic steroid treatment
16 Years
FEMALE
Yes
Sponsors
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St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia
UNKNOWN
Ipas
OTHER
Responsible Party
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Principal Investigators
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Nathalie Kapp, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Ipas
Locations
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St. Paul's Hospital Millennium Medical College
Addis Ababa, , Ethiopia
Countries
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Other Identifiers
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PM23/146
Identifier Type: -
Identifier Source: org_study_id
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