Clinical trial NCT03727308: Study of Clinic-based Versus Self-use of Medical Abortion Pills
Official title: A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induced Abortion
First Trimester Abortion
Misoprostol
Mifepristone
Keywords: medical abortion
self-use
Lead sponsor: Ipas
Sponsor class: OTHER
Collaborators: name: University of Health Science, Phnom Penh, Cambodia
First posted: 2018-11-01
Enrollment: 4196
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are pregnant and seeking abortion in study sites.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for additional treatment to complete abortion
timeFrame: Final assessment at 30 days following mifepristone administration
Secondary outcomes:
measure: Serious complications/ morbidity
timeFrame: Final assessment at 30 days following mifepristone administration
Other outcomes:
measure: Uptake of postabortion contraception
timeFrame: 30 days
Locations:
city: Phnom Penh
country: Cambodia
facility: University of Health Sciences
city: Accra
country: Ghana
facility: Regional Institute for Population Studies
Study officials:
affiliation: Ipas
name: Nathalie Kapp, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: