Induced AbortionNCT04242212
Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion
An observational study of Induced Abortion and First Trimester Abortion, run by Ipas at 3 sites in Nigeria.
Trial summary
The goal of the study is to determine whether important clinical outcomes differ among women who access a misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Abortion, First Trimester Abortion
- What is being tested?
- Misoprostol sourced from clinics and Misoprostol sourced from PMVs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,000 participants
- Where
- 3 sitesNigeria
- Study dates
- 19 May 2019to 30 Jun 2020
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Nigerian women, age 15-49, living in the study geography, who are pregnant and seeking a misoprostol-only regimen for medication abortion, either from a patent medicine vendor or a healthcare clinic/facility.
Who may be able to join
- Purchased a misoprostol-only abortion regimen at a PMV or from a clinic
- Be at least 15 years of age
- Have a known LMP of less than 9 weeks
- No contraindications to medical abortion
- 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 at 1-3, 10-29 and 30-45 days following initial contact.
Who cannot join
- Contraindications to misoprostol
- Age <15 or >49
Trial locations and contacts
3 sites in 1 country.
Nigeria3 sites, 3 recruiting
- Recruiting
Multiple facilities
Abeokuta, Ogun State
- Recruiting
Multiple facilities
Awka, Anambra
- Recruiting
Multiple facilities
Ibadan, Oyo State
About this study
Official title: A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen
The goal of the study is to determine whether important clinical outcomes differ among women who access a misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic.
Read the detailed description
Medication abortion with a misoprostol-only regimen within the first 10 weeks of pregnancy is safe and effective. Investigators aim to assess whether self-use of early (<9 weeks) medication abortion using a misoprostol-only regimen results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medication abortion.
The investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.
- Conditions
- Induced Abortion, First Trimester Abortion
- Being tested
- Misoprostol sourced from clinics, Misoprostol sourced from PMVs
- Keywords
- Medication abortion, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol sourced from clinicsBehavioural
One cohort of women using misoprostol sourced from clinics
Misoprostol sourced from PMVsBehavioural
One cohort of women using misoprostol sourced from PMVs
| Study group | Role | What they receive |
|---|---|---|
| Clinic-based | Women who get misoprostol from a clinic-based provider Receives: Behavioral: Misoprostol sourced from clinics | |
| PMV-based | Women who get misoprostol from a patent medicine vendor Receives: Behavioral: Misoprostol sourced from PMVs |
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 >3 doses) following a woman taking the medication abortion pills.
Measured: Final assessment at 45 days following misoprostol
Secondary outcomes (1)
Serious complications/ morbidity
Number of participants who have a complication such as hemorrhage requiring a blood transfusion, hospitalization, serious infection and undiagnosed (at the time of misoprostol) ectopic pregnancy.
Measured: Final assessment at 45 days following misoprostol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start19 May 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242212
- Sponsor's protocol ID
- Ipas_NMAS
- Status last verified
- Feb 2020
- First submitted
- 23 Jan 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shellenberg KM, Storey S, Griffin R, Okwesa N, Oginni A, Adelekan B. Self-managed medical abortion in Nigeria: a prospective, comparative study of clinical outcomes for a misoprostol-alone regimen obtained from patent medicine vendors compared to clinics. Reprod Health. 2026 Mar 26;23(1):93. doi: 10.1186/s12978-026-02305-0.
PubMed 41888911
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. 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 Medication Abortion Using a Misoprostol-only Regimen
- ClinicalTrials.gov ID
- NCT04242212
- Acronym / sponsor ID
- Ipas_NMAS
- Conditions
- Induced Abortion, First Trimester Abortion
- Keywords
- Medication abortion, Misoprostol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- IpasUniversity, hospital or other
- Study start
- 19 May 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 27 Jan 2020 (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 misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic.
Detailed description
Medication abortion with a misoprostol-only regimen within the first 10 weeks of pregnancy is safe and effective. Investigators aim to assess whether self-use of early (<9 weeks) medication abortion using a misoprostol-only regimen results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medication abortion.
The investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic-based | – | Behavioral: Misoprostol sourced from clinicsWomen who get misoprostol from a clinic-based provider |
| PMV-based | – | Behavioral: Misoprostol sourced from PMVsWomen who get misoprostol from a patent medicine vendor |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Nigerian women, age 15-49, living in the study geography, who are pregnant and seeking a misoprostol-only regimen for medication abortion, either from a patent medicine vendor or a healthcare clinic/facility.
Key inclusion criteria (7 listed)
- Purchased a misoprostol-only abortion regimen at a PMV or from a clinic
- Be at least 15 years of age
- Have a known LMP of less than 9 weeks
- No contraindications to medical abortion
- Willing and able to give informed consent
Key exclusion criteria (2 listed)
- Contraindications to misoprostol
- Age <15 or >49
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 |
|---|---|---|
| Misoprostol sourced from clinicsOne cohort of women using misoprostol sourced from clinics | Behavioural | Clinic-based |
| Misoprostol sourced from PMVsOne cohort of women using misoprostol sourced from PMVs | Behavioural | PMV-based |
Primary outcome
Need for additional treatment to complete abortion
Time frame: Final assessment at 45 days following misoprostol
The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol >3 doses) following a woman taking the medication abortion pills.
1 secondary outcome
Serious complications/ morbidity
Time frame: Final assessment at 45 days following misoprostol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Derived from this study: PubMed 41888911Shellenberg KM, Storey S, Griffin R, Okwesa N, Oginni A, Adelekan B. Self-managed medical abortion in Nigeria: a prospective, comparative study of clinical outcomes for a misoprostol-alone regimen obtained from patent medicine vendors compared to clinics. Reprod Health. 2026 Mar 26;23(1):93. doi: 10.1186/s12978-026-02305-0.
- 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.
3 sites in 1 country: 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 3 sites in Nigeria.
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 7 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: status not confirmed, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristen M Shellenberg, PhD, MPH (1.310.733.6524, shellenbergk@ipas.org), or a site near the patient. 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 45 days following misoprostol). 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 NCT04242212, 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 24 Feb 2020.