Induced AbortionNCT04181541
Midlevel Versus Physician-provided Medical Abortion in the Second Trimester
A study testing Provider type: Physicians and Provider type: Midlevel Providers in people with Induced Abortion and Second Trimester Abortion, run by Ipas at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Abortion, Second Trimester Abortion, Medical Abortion
- What is being tested?
- Provider type: Physicians and Provider type: Midlevel Providers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteEthiopia
- Study dates
- 17 Feb 2020to 3 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Provider type: Physicians, Provider type: Midlevel Providers
- Keywords
- Midlevel provider
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider type: PhysiciansProcedure or surgery
In this cohort, women will receive second trimester medical abortion care from physicians
Provider type: Midlevel ProvidersProcedure or surgery
In this cohort, women will receive second trimester medical abortion care from midlevel providers.
| Study group | Role | What they receive |
|---|---|---|
| Women receiving abortion care by physicians | Active comparator | Patients who receive second trimester medical abortion care from a physician. Receives: Procedure: Provider type: Physicians |
| Women receiving abortion care from midlevel providers | Experimental | Patients who receive second trimester medical abortion care from a midlevel provider. Receives: Procedure: Provider type: Midlevel Providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to expulsion
Time to expulsion of fetus after medical abortion regimen initiated
Measured: Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours
Secondary outcomes (5)
Total number of misoprostol doses
Doses of misoprostol needed for completion of abortion
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: up to 7 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start17 Feb 2020
- Primary completion24 Feb 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipas
- Sponsor type
- University, hospital or other
- Collaborators
- St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia
- Responsible party
- Sponsor
- Investigators
- Nathalie Kapp, MD, MPH, Principal investigator, Ipas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181541
- Sponsor's protocol ID
- PM23/146
- Status last verified
- Sep 2021
- First submitted
- 22 Nov 2019
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Midlevel Providers Manage Medical Abortion in the Second Trimester as Safely and Effectively as Physicians? A Randomized Controlled Trial in Ethiopia
- ClinicalTrials.gov ID
- NCT04181541
- Acronym / sponsor ID
- PM23/146
- Keywords
- Midlevel provider
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- IpasUniversity, hospital or other
- Collaborators
- St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Women receiving abortion care by physicians | Active comparator | Procedure: Provider type: PhysiciansPatients who receive second trimester medical abortion care from a physician. |
| Women receiving abortion care from midlevel providers | Experimental | Procedure: Provider type: Midlevel ProvidersPatients who receive second trimester medical abortion care from a midlevel provider. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provider type: PhysiciansIn this cohort, women will receive second trimester medical abortion care from physicians | Procedure or surgery | Women receiving abortion care by physicians |
| Provider type: Midlevel ProvidersIn this cohort, women will receive second trimester medical abortion care from midlevel providers. | Procedure or surgery | Women receiving abortion care from midlevel providers |
Primary outcome
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
5 secondary outcomes
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
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)
Need for intervention by a physician
Time frame: 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)
Adverse events
Time frame: up to 7 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Kapp, MD, MPH principal investigator
Ipas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider type: Physicians and Provider type: Midlevel Providers in people with Induced Abortion and Second Trimester Abortion, run by Ipas at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to expulsion (time frame: Time (hours/minutes) from first dose of misoprostol until the fetus is expelled, up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.