Midlevel Versus Physician-provided Medical Abortion in the Second Trimester
Study Details
Study Description
Brief Summary
The purpose of the study is to determine the safety and effectiveness of second trimester medical abortion when provided by nurse midwives compared with physicians. The study sample will be obtained from Michu Clinic, affiliated with St Paul's hospital, in Addis Ababa.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
About 10% of all abortions globally take place at or after 13 weeks gestation. Women seeking second-trimester abortion services are often the most vulnerable and socially disadvantaged population.Studies show the rate of second-trimester abortion procedures remains stable over time, even in high-access locations, confirming the ongoing need for accessibility to services in rural locations with limited access to care. In Ethiopia, second-trimester abortion services are widely available in Addis Ababa, making up a high proportion of the total number of abortions occurring each year in the country; however, access to accurate and reliable data is limited.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Women receiving abortion care by physicians Patients who receive second trimester medical abortion care from a physician. |
Procedure: Provider type: Physicians
In this cohort, women will receive second trimester medical abortion care from physicians
|
| Experimental: Women receiving abortion care from midlevel providers Patients who receive second trimester medical abortion care from a midlevel provider. |
Procedure: Provider type: Midlevel Providers
In this cohort, women will receive second trimester medical abortion care from midlevel providers.
|
Outcome Measures
Primary Outcome Measures
- Time to expulsion [Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours]
Time to expulsion of fetus after medical abortion regimen initiated
Secondary Outcome Measures
- Total number of misoprostol doses [Time (hours/minutes) from first dose of misoprostol until the fetus and placenta are expelled, up to 72 hours]
Doses of misoprostol needed for completion of abortion
- Need for ultrasound to confirm gestational age [At the time of eligibility for the abortion is assessed, need for confirmatory ultrasound recorded (up to 1 day)]
Whether ultrasound was needed to estimate gestational age
- Need for intervention by a physician [Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days)]
whether any physician involvement was needed to manage the case (from nurse-led services)
- Serious complications/ morbidity [Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days)]
Whether the following complications occur while a patient is receiving abortion services: hemorrhage requiring transfusion, placental retention requiring removal, uterine rupture, fever/ signs of infection requiring antibiotic treatment.
- Adverse events [up to 7 days after discharge]
Whether adverse events occurred that required a return to the hospital after discharge from Michu clinic.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Willing and able to give consent for participation
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Intrauterine pregnancy with confirmed gestational age >13 weeks and <20 weeks
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Presenting for induced abortion at Michu Clinic
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Speaker of Amharic or Oromo
Exclusion Criteria:
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Women unable to give consent for participation
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Gestational age <13 or >20 weeks
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Adolescents aged less than 16 years
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Women with an allergy to or contraindications to mifepristone or misoprostol
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Women with a history of more than one previous hysterotomy
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Women seeking treatment for incomplete abortion, intrauterine fetal demise, or postabortion care
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Women with chronic hypertension or adrenal failure
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Women on chronic steroid treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Paul's Hospital Millennium Medical College | Addis Ababa | Ethiopia |
Sponsors and Collaborators
- Ipas
- St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia
Investigators
- Principal Investigator: Nathalie Kapp, MD, MPH, Ipas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PM23/146