The purpose of this study is to assess the effectiveness, safety, and acceptability of home-administered medical abortion at gestational age of 8 to ≤9 weeks versus \>9 to ≤12 weeks among a cohort of women in Mexico City.
Medical abortion represents an important alternative to surgical methods for termination of early pregnancy. In Mexico City, abortion is legal on request up to 12 weeks of gestation; however, medical abortion is currently only offered up to 10 weeks at Marie Stopes Mexico clinics. The World Health Organization guidelines state that medical abortion drugs may be used to terminate pregnancy up to a gestational age of 24 weeks in clinical settings, with recommended regimens differing by gestational age. However, data are lacking on the safety and effectiveness of home-based medical abortion regimens for pregnancy terminations between \>9 and ≤12 weeks' gestation. Investigators propose a prospective cohort study with women between 8 and ≤9 weeks and \>9 and ≤12 weeks of pregnancy at Marie Stopes Mexico clinics to compare the effectiveness, safety, and acceptability of mifepristone followed by home-based misoprostol use in these two gestational age groups. The information from this study will inform policy and practice guidelines in Mexico City and potentially other locations by providing evidence on the safety, effectiveness, and acceptability of home-use of medical abortion between \>9 and ≤12 weeks of gestation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
648
Women at 64-84 days' gestation will use the following dosing regimen: 200 µg mifepristone administered orally in the clinic on Day 1.
The client will then be given a total of 2400 µg misoprostol tablets to take home, and will be instructed to take 800 μg misoprostol administered sublingually 24-48 hours later at home and to administer a subsequent dose of 400 μg misoprostol sublingually every 3 hours up to a total of four further doses or until expulsion of the products of conception, whichever comes first.
Marie Stopes Mexico Azcapotzalco
Del. Azcapotzalco, Mexico Distrito Federal, Mexico
Marie Stopes Mexico Roma
Del. Cuauhtémoc, Mexico Distrito Federal, Mexico
Marie Stopes Mexico Pedregal
Del. Tlalpan, Mexico Distrito Federal, Mexico
Proportion of participants with complete abortion without surgical intervention by day 30 from mifepristone administration, regardless of misoprostol dosing, by gestational age group
Time frame: 2-4 weeks
Experience of any major adverse event overall, and by type (emergency room treatment, hospitalization, transfusion, unrecognized ectopic pregnancy, allergic reaction, infection requiring intravenous treatment, and death), by gestational age group
Time frame: 2-4 weeks
Proportion of participants by gestational age group with complete abortion without surgical intervention after 1, 2, 3, 4, and 5 doses of misoprostol, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to the presence of a persistent non-viable sac, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to substantial debris in uterus, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to excessive prolonged bleeding indicated as severe on the adverse event form, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group
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Time frame: 2-4 weeks
Number of participants requiring an unscheduled clinic visit, by gestational age group
Time frame: 2-4 weeks
Number of participants who called the helpline, by gestational age group
Time frame: 2-4 weeks
Time to expulsion in days, by gestational age group
Time frame: 2-4 weeks
Side effects overall and by type (chills, fever, vomiting, nausea, diarrhoea, and severe pain), by gestational age group
Time frame: 2-4 weeks
Duration of heavy bleeding, by gestational age group
Time frame: 2-4 weeks
Duration of work or school missed, by gestational age group
Time frame: 2-4 weeks
Pain reliever use
Time frame: 2-4 weeks
Satisfied or very satisfied with abortion method, by gestational age group
Time frame: 2-4 weeks
Would choose medical abortion again instead of surgical, by gestational age group
Time frame: 2-4 weeks
Would recommend abortion method to a friend, by gestational age group
Time frame: 2-4 weeks
Proportion of participants who saw products of pregnancy, by gestational age group
Time frame: 2-4 weeks
Proportion of participants who saw products of pregnancy who reported feelings as: nothing/no feeling, relieved, sad, uncomfortable, other, by gestational group
Time frame: 2-4 weeks
Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention
Time frame: 2-4 weeks
Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention
Time frame: 2-4 weeks
Did not receive a contraceptive method by follow-up visit, but don't want to get pregnant in next 12 months, by gestational age group
Time frame: 2-4 weeks