NCT04181541

Midlevel Versus Physician-provided Medical Abortion in the Second Trimester

Can Midlevel Providers Manage Medical Abortion in the Second Trimester as Safely and Effectively as Physicians? A Randomized Controlled Trial in Ethiopia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Ipas · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Induced Abortion
• Second Trimester Abortion
• Medical Abortion
• Health Personnel

Interventions

Type	Name	Description
PROCEDURE	Provider type: Physicians	In this cohort, women will receive second trimester medical abortion care from physicians
PROCEDURE	Provider type: Midlevel Providers	In this cohort, women will receive second trimester medical abortion care from midlevel providers.

Timeline

• Start date: 2020-02-17
• Primary completion: 2021-02-24
• Completion: 2021-03-03
• First posted: 2019-11-29
• Last updated: 2021-09-20

Locations

1 site across 1 country: Ethiopia