First Trimester Abortion, Induced Abortion
Conditions
Keywords
Medication abortion, Misoprostol
Brief 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.
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.
Interventions
BEHAVIORALMisoprostol sourced from clinics
One cohort of women using misoprostol sourced from clinics
BEHAVIORALMisoprostol sourced from PMVs
One cohort of women using misoprostol sourced from PMVs
Sponsors
Ipas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Contraindications to misoprostol * Age \<15 or \>49
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for additional treatment to complete abortion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious complications/ morbidity | Final assessment at 45 days following misoprostol | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Uptake of postabortion contraception | Final assessment at 45 days following misoprostol | Women's reported use of contraception (yes or no and method type) following medication abortion. |
Countries
Nigeria
Contacts
Primary ContactKristen M Shellenberg, PhD, MPH
Backup ContactNathalie Kapp, MD, MPH
Outcome results
None listed