Midlevel Versus Physician-provided Medical Abortion in the Second Trimester

September 17, 2021 updated by: Ipas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia
        • St. Paul's Hospital Millennium Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Women receiving abortion care by physicians
Patients who receive second trimester medical abortion care from a physician.
Procedure: Provider type: Physicians
In this cohort, women will receive second trimester medical abortion care from physicians
Experimental: Women receiving abortion care from midlevel providers
Patients who receive second trimester medical abortion care from a midlevel provider.
Procedure: Provider type: Midlevel Providers
In this cohort, women will receive second trimester medical abortion care from midlevel providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to expulsion
Time Frame: Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of misoprostol doses
Time Frame: Time (hours/minutes) from first dose of misoprostol until the fetus and placenta are expelled, up to 72 hours
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
Time Frame: At the time of eligibility for the abortion is assessed, need for confirmatory ultrasound recorded (up to 1 day)
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
Time Frame: Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days)
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
Time Frame: Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days)
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
Time Frame: up to 7 days after discharge
Whether adverse events occurred that required a return to the hospital after discharge from Michu clinic.
up to 7 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipas

Collaborators

St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia

Investigators

  • Principal Investigator: Nathalie Kapp, MD, MPH, Ipas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2020

Primary Completion (Actual)

February 24, 2021

Study Completion (Actual)

March 3, 2021

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM23/146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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