Clinical trial NCT04181541: Midlevel Versus Physician-provided Medical Abortion in the Second Trimester
Official title: Can Midlevel Providers Manage Medical Abortion in the Second Trimester as Safely and Effectively as Physicians? A Randomized Controlled Trial in Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Abortion
Second Trimester Abortion
Medical Abortion
Health Personnel
Keywords: Midlevel provider
Lead sponsor: Ipas
Sponsor class: OTHER
Collaborators: name: St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia
First posted: 2019-11-29
Enrollment: 245
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators propose a randomized, controlled, non-inferiority study comparing management of medical abortion by either nurse midwives or physicians for women undergoing induced abortion at a gestational ages \> 13 weeks.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to expulsion
timeFrame: Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours
Secondary outcomes:
measure: Total number of misoprostol doses
timeFrame: Time (hours/minutes) from first dose of misoprostol until the fetus and placenta are expelled, up to 72 hours
measure: Need for ultrasound to confirm gestational age
timeFrame: At the time of eligibility for the abortion is assessed, need for confirmatory ultrasound recorded (up to 1 day)
measure: Need for intervention by a physician
timeFrame: Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days)
measure: Serious complications/ morbidity
timeFrame: Assessed at the time of discharge and reflecting entire duration of hospitalization (up to 7 days)
measure: Adverse events
timeFrame: up to 7 days after discharge
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: St. Paul's Hospital Millennium Medical College
Study officials:
affiliation: Ipas
name: Nathalie Kapp, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: