Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks
Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks
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.
Inclusion Criteria:

 -  Aged 18 or older

 -  Intrauterine pregnancy 57- 84 days, assessed using clinical assessment and
 transvaginal or transabdominal ultrasound by crown-rump length (machines will be
 calibrated and will use a standardized conversion formula to determine gestational
 age)

 -  Eligible for medical abortion according to doctor assessment

 -  Elected medical abortion over surgical abortion after comprehensive counselling

 -  Haemoglobin level ≥10 g/dl measured by Hemocue

 -  Willing and able to sign consent forms

 -  Able to speak and read Spanish

 -  Agree to comply with the study procedures and visit schedule

 -  Access to own telephone and to emergency transportation

 -  Access to a toilet with privacy

 -  Reside no more than 30 minutes car journey from the Sta. Mónica Hospital in Polanco or
 the Marie Stopes Mexico Roma Clinic

 Exclusion Criteria:

 -  History or evidence of disorders that represent a contraindication to the use of
 mifepristone or misoprostol (chronic adrenal failure, severe asthma uncontrolled by
 corticosteroid therapy, inherited porphyries, glaucoma, mitral stenosis, hepatic or
 renal disease)

 -  History of bleeding disorder or current anticoagulant therapy

 -  Previous allergic reaction to any drugs in the regimen

 -  Suspicion of any pathology of pregnancy (e.g. molar, ectopic, non-viable pregnancy)

 -  Multiple gestation

 -  Presence of an intrauterine device