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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
245
In this cohort, women will receive second trimester medical abortion care from physicians
In this cohort, women will receive second trimester medical abortion care from midlevel providers.
St. Paul's Hospital Millennium Medical College
Addis Ababa, Ethiopia
Time to expulsion
Time to expulsion of fetus after medical abortion regimen initiated
Time frame: Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours
Total number of misoprostol doses
Doses of misoprostol needed for completion of abortion
Time frame: 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
Whether ultrasound was needed to estimate gestational age
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: up to 7 days after discharge
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