Midlevel Versus Physician-provided Medical Abortion in the Second Trimester

Medical Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181541
• Other study ID #: PM23/146
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: March 3, 2021

Study information

• Verified date: September 2021
• Source: Ipas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: March 3, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Provider type: Physicians
In this cohort, women will receive second trimester medical abortion care from physicians
• Provider type: Midlevel Providers
In this cohort, women will receive second trimester medical abortion care from midlevel providers.

Locations

Country	Name	City	State
Ethiopia	St. Paul's Hospital Millennium Medical College	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
Ipas	St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Need for ultrasound to confirm gestational age	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)
Secondary	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)
Secondary	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)
Secondary	Adverse events	Whether adverse events occurred that required a return to the hospital after discharge from Michu clinic.	up to 7 days after discharge