First Trimester Abortion, Induced Abortion, Mifepristone, Misoprostol
Conditions
Keywords
medical abortion, self-use
Brief 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.
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.
Interventions
BEHAVIORALMedical abortion pills sourced from pharmacies
One cohort using medical abortion pills sourced from pharmacies
BEHAVIORALMedical abortion pills sourced from health clinics
One cohort using medical abortion pills sourced from health clinics
Sponsors
University of Health Science, Phnom Penh, Cambodia
Ipas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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: * 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.
Exclusion criteria
* Contraindications to mifepristone-misoprostol * Age \<15
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for additional treatment to complete abortion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious complications/ morbidity | Final assessment at 30 days following mifepristone administration | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Uptake of postabortion contraception | 30 days | Women's reported use of contraception (yes or no and method type) following medical abortion |
Countries
Cambodia, Ghana
Outcome results
None listed