Midlevel Versus Physician-provided Medical Abortion in the Second Trimester

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Induced Abortion, Second Trimester Abortion, Medical Abortion, Health Personnel

Intervention / Treatment
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* Procedure: Provider type: Physicians
* Procedure: Provider type: Midlevel Providers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| Adverse events | Whether adverse events occurred that required a return to the hospital after discharge from Michu clinic. | up to 7 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midlevel provider