Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ibis Reproductive Health
• Collaborator: Marie Stopes International
• Treatments: Mifepristone; Misoprostol

Criteria

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