Induced AbortionMOCNCT03727308
Study of Clinic-based Versus Self-use of Medical Abortion Pills
An observational study of Induced Abortion and First Trimester Abortion, run by Ipas at 2 sites in 2 countries.
Trial summary
The goal of the study is to determine whether important clinical outcomes differ among women who access a combined medical abortion regimen from a pharmacy when compared with those who access it from a facility. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Abortion, First Trimester Abortion, Misoprostol
- What is being tested?
- Medical abortion pills sourced from pharmacies and Medical abortion pills sourced from health clinics
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 4,196 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 May 2018to 2 Jun 2021
- Phase
- Observational
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women who are pregnant and seeking abortion in study sites.
Who may be able to join
- Women are eligible for participation if they have purchased abortion medications (mifepristone-misoprostol) independently at a pharmacy or received them from a clinic for an unwanted pregnancy at less than 9 weeks since her last menstrual period (LMP). She must meet the following criteria:
- Be at least 15 years of age (may vary by country)
- Have a known LMP of less than 9 weeks
- No contraindications to medical abortion (list)
- Willing and able to give informed consent
- Have a mobile phone of which they are the independent user or be willing to be followed-up in person
- Willing to be contacted with questions about her abortion by telephone (optional in-person visit) at 3, 10-14 and 30 days following initial contact.
- Resident of country of study.
Who cannot join
- Contraindications to mifepristone-misoprostol
- Age <15
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol
The goal of the study is to determine whether important clinical outcomes differ among women who access a combined medical abortion regimen from a pharmacy when compared with those who access it from a facility.
Read the detailed description
Medical abortion with mifepristone and misoprostol within the first 10 weeks of pregnancy is safe and highly effective. Investigators aim to assess whether self-use of early (<9 weeks) medical abortion using mifepristone with misoprostol results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medical abortion.
The investigators will prospectively recruit women who obtain medical abortion medication from pharmacies and clinics. Follow-up will occur by telephone during two phone calls within 30 days following the woman's abortion. A small number of adolescents will be recruited into a qualitative substudy.
- Conditions
- Induced Abortion, First Trimester Abortion, Misoprostol, Mifepristone
- Being tested
- Medical abortion pills sourced from pharmacies, Medical abortion pills sourced from health clinics
- Keywords
- medical abortion, self-use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical abortion pills sourced from pharmaciesBehavioural
One cohort using medical abortion pills sourced from pharmacies
Medical abortion pills sourced from health clinicsBehavioural
One cohort using medical abortion pills sourced from health clinics
| Study group | Role | What they receive |
|---|---|---|
| Women recruited from pharmacies | Investigators will enroll women seeking medical abortion pills without prescription from pharmacies.
- Medical abortion pills sourced from pharmacies Receives: Behavioral: Medical abortion pills sourced from pharmacies | |
| Women recruited from health clinics | Investigators will enroll women seeking medical abortion pills from clinics.
- Medical abortion pills sourced from health clinics Receives: Behavioral: Medical abortion pills sourced from health clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for additional treatment to complete abortion
The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol) following a woman taking the medical abortion pills.
Measured: Final assessment at 30 days following mifepristone administration
Secondary outcomes (1)
Serious complications/ morbidity
Number of participants who will have a complication such as hemorrhage requiring a blood transfusion, hospitalization, serious infection and undiagnosed (at the time of mifepristone) ectopic pregnancy.
Measured: Final assessment at 30 days following mifepristone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start30 May 2018
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Health Science, Phnom Penh, Cambodia
- Responsible party
- Sponsor
- Investigators
- Nathalie Kapp, MD, MPH, Principal investigator, Ipas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727308
- Sponsor's protocol ID
- 0916 NECHR
- Acronym
- MOC
- Status last verified
- Sep 2021
- First submitted
- 28 Oct 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kapp N, Bawah AA, Agula C, Menzel JL, Antobam SK, Asuming PO, Eckersberger E, Pearson EE. Medical abortion in Ghana: A non-randomized, non-inferiority study of access through pharmacies compared with clinics. Contraception. 2024 Dec;140:110538. doi: 10.1016/j.contraception.2024.110538. Epub 2024 Jul 11.
PubMed 39002625
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol
- ClinicalTrials.gov ID
- NCT03727308
- Acronym / sponsor ID
- MOC / 0916 NECHR
- Conditions
- Induced Abortion, First Trimester Abortion, Misoprostol, Mifepristone
- Keywords
- medical abortion, self-use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,196 participants (actual)
- Lead sponsor
- IpasUniversity, hospital or other
- Collaborators
- University of Health Science, Phnom Penh, Cambodia
- Study start
- 30 May 2018 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 1 Nov 2018 (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 goal of the study is to determine whether important clinical outcomes differ among women who access a combined medical abortion regimen from a pharmacy when compared with those who access it from a facility.
Detailed description
Medical abortion with mifepristone and misoprostol within the first 10 weeks of pregnancy is safe and highly effective. Investigators aim to assess whether self-use of early (<9 weeks) medical abortion using mifepristone with misoprostol results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medical abortion.
The investigators will prospectively recruit women who obtain medical abortion medication from pharmacies and clinics. Follow-up will occur by telephone during two phone calls within 30 days following the woman's abortion. A small number of adolescents will be recruited into a qualitative substudy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women recruited from pharmacies | – | Behavioral: Medical abortion pills sourced from pharmaciesInvestigators will enroll women seeking medical abortion pills without prescription from pharmacies. - Medical abortion pills sourced from pharmacies |
| Women recruited from health clinics | – | Behavioral: Medical abortion pills sourced from health clinicsInvestigators will enroll women seeking medical abortion pills from clinics. - Medical abortion pills sourced from health clinics |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who are pregnant and seeking abortion in study sites.
Key inclusion criteria (8 listed)
- Women are eligible for participation if they have purchased abortion medications (mifepristone-misoprostol) independently at a pharmacy or received them from a clinic for an unwanted pregnancy at less than 9 weeks since her last menstrual period (LMP). She must meet the following criteria:
- Be at least 15 years of age (may vary by country)
- Have a known LMP of less than 9 weeks
- No contraindications to medical abortion (list)
- Willing and able to give informed consent
Key exclusion criteria (2 listed)
- Contraindications to mifepristone-misoprostol
- Age <15
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 |
|---|---|---|
| Medical abortion pills sourced from pharmaciesOne cohort using medical abortion pills sourced from pharmacies | Behavioural | Women recruited from pharmacies |
| Medical abortion pills sourced from health clinicsOne cohort using medical abortion pills sourced from health clinics | Behavioural | Women recruited from health clinics |
Primary outcome
Need for additional treatment to complete abortion
Time frame: Final assessment at 30 days following mifepristone administration
The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol) following a woman taking the medical abortion pills.
1 secondary outcome
Serious complications/ morbidity
Time frame: Final assessment at 30 days following mifepristone administration
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 5 Sep 2021.
- Derived from this study: PubMed 39002625Kapp N, Bawah AA, Agula C, Menzel JL, Antobam SK, Asuming PO, Eckersberger E, Pearson EE. Medical abortion in Ghana: A non-randomized, non-inferiority study of access through pharmacies compared with clinics. Contraception. 2024 Dec;140:110538. doi: 10.1016/j.contraception.2024.110538. Epub 2024 Jul 11.
- 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induced Abortion and First Trimester Abortion, run by Ipas at 2 sites in 2 countries.
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 8 inclusion and 2 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 5 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 2 sites in Cambodia, Ghana. 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?
Need for additional treatment to complete abortion (time frame: Final assessment at 30 days following mifepristone administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727308, which also lists 1 linked publication.
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 5 Sep 2021.