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| Name | Class |
|---|---|
| University of Health Science, Phnom Penh, Cambodia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women recruited from pharmacies | Investigators will enroll women seeking medical abortion pills without prescription from pharmacies. - 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical abortion pills sourced from pharmacies | Behavioral | One cohort using medical abortion pills sourced from pharmacies |
|
| 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) following a woman taking the medical abortion pills. | Final assessment at 30 days following mifepristone administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Final assessment at 30 days following mifepristone administration |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of postabortion contraception | Women's reported use of contraception (yes or no and method type) following medical abortion | 30 days |
Inclusion Criteria:
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:
Exclusion criteria:
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Women who are pregnant and seeking abortion in study sites.
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Kapp, MD, MPH | Ipas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences | Phnom Penh | Cambodia | ||||
| Regional Institute for Population Studies |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39002625 | Derived | 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. |
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| Medical abortion pills sourced from health clinics | Behavioral | One cohort using medical abortion pills sourced from health clinics |
|
| Accra |
| Ghana |