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Completed

NCT Number: NCT04181541

Midlevel Versus Physician-provided Medical Abortion in the Second Trimester

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.

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Key information

Conditions

Induced Abortion Health Personnel Medical Abortion Second Trimester Abortion

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital Millennium Medical College

Addis Ababa, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provider type: Physicians

Procedure

In this cohort, women will receive second trimester medical abortion care from physicians

Provider type: Midlevel Providers

Procedure

In this cohort, women will receive second trimester medical abortion care from midlevel providers.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Ipas

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2019
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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