Midlevel Versus Physician-provided Medical Abortion in the Second Trimester

Ipas

Status: Completed

Conditions: Induced Abortion; Health Personnel; Medical Abortion; Second Trimester Abortion

Treatments: Procedure: Provider type: Midlevel Providers; Procedure: Provider type: Physicians

Study type: Interventional

Funder types: Other

Identifiers

NCT04181541

PM23/146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Willing and able to give consent for participation
• 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

• Women unable to give consent for participation
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

Women receiving abortion care by physicians

Active Comparator group

Description:

Patients who receive second trimester medical abortion care from a physician.

Treatment:

Procedure: Provider type: Physicians

Women receiving abortion care from midlevel providers

Experimental group

Description:

Patients who receive second trimester medical abortion care from a midlevel provider.

Treatment:

Procedure: Provider type: Midlevel Providers