Study of Clinic-based Versus Self-use of Medical Abortion Pills

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol

Conditions
-----------------
Induced Abortion, First Trimester Abortion, Misoprostol, Mifepristone

Intervention / Treatment
-----------------
* Behavioral: Medical abortion pills sourced from pharmacies
* Behavioral: Medical abortion pills sourced from health clinics


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women recruited from pharmacies<br>Investigators will enroll women seeking medical abortion pills without prescription from pharmacies. - Medical abortion pills sourced from pharmacies | Behavioral: Medical abortion pills sourced from pharmacies<br>* One cohort using medical abortion pills sourced from pharmacies<br>|
| Women recruited from health clinics<br>Investigators will enroll women seeking medical abortion pills from clinics. - Medical abortion pills sourced from health clinics | Behavioral: Medical abortion pills sourced from health clinics<br>* One cohort using medical abortion pills sourced from health clinics<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical abortion, self-use