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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic-based | Women who get misoprostol from a clinic-based provider |
| |
| PMV-based | Women who get misoprostol from a patent medicine vendor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol sourced from clinics | Behavioral | One cohort of women using misoprostol sourced from clinics |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Final assessment at 45 days following misoprostol |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Final assessment at 45 days following misoprostol |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of postabortion contraception | Women's reported use of contraception (yes or no and method type) following medication abortion. | Final assessment at 45 days following misoprostol |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen M Shellenberg, PhD, MPH | Contact | 1.310.733.6524 | shellenbergk@ipas.org | |
| Nathalie Kapp, MD, MPH | Contact | 1.919.960.5611 | kappn@ipas.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple facilities | Recruiting | Awka | Anambra | Nigeria | ||
| Multiple facilities |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41888911 | Derived | 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. |
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| Misoprostol sourced from PMVs | Behavioral | One cohort of women using misoprostol sourced from PMVs |
|
| Recruiting |
| Abeokuta |
| Ogun State |
| Nigeria |
| Multiple facilities | Recruiting | Ibadan | Oyo State | Nigeria |