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| Name | Class |
|---|---|
| St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women receiving abortion care by physicians | Active Comparator | Patients who receive second trimester medical abortion care from a physician. |
|
| Women receiving abortion care from midlevel providers | Experimental | Patients who receive second trimester medical abortion care from a midlevel provider. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provider type: Physicians | Procedure | In this cohort, women will receive second trimester medical abortion care from physicians |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to expulsion | Time to expulsion of fetus after medical abortion regimen initiated | Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of misoprostol doses | Doses of misoprostol needed for completion of abortion | Time (hours/minutes) from first dose of misoprostol until the fetus and placenta are expelled, up to 72 hours |
| Need for ultrasound to confirm gestational age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Kapp, MD, MPH | Ipas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital Millennium Medical College | Addis Ababa | Ethiopia |
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The investigators propose a randomized, controlled, non-inferiority study comparing management of medical abortion by either nurse midwives or physicians for women undergoing induced abortion at a gestational ages > 13 weeks.
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| Provider type: Midlevel Providers | Procedure | In this cohort, women will receive second trimester medical abortion care from midlevel providers. |
|
Whether ultrasound was needed to estimate gestational age
| At the time of eligibility for the abortion is assessed, need for confirmatory ultrasound recorded (up to 1 day) |
| Need for intervention by a physician | whether any physician involvement was needed to manage the case (from nurse-led services) | Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days) |
| Serious complications/ morbidity | 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. | Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days) |
| Adverse events | Whether adverse events occurred that required a return to the hospital after discharge from Michu clinic. | up to 7 days after discharge |