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

Ibis Reproductive Health

Status and phase: Unknown; Phase 4

Conditions: Medical Abortion

Treatments: Drug: Mifepristone; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02745093

MSI-6103

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 648 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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648 participants in 2 patient groups

64-84 days gestational age

Experimental group

Description:

Women whose pregnancies are estimated to have a gestational age of 64-84 days will receive 200 µg mifepristone followed by misoprostol 24-48 hours later.

Treatment:

Drug: Misoprostol

Drug: Mifepristone

57-63 days gestational age

No Intervention group

Description:

Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range: 200 µg mifepristone administered orally in the clinic on Day 1 then 800 μg misoprostol administered sublingually 24-48 hours later at home with a subsequent dose of 400 μg misoprostol sublingually 6 hours later if she has not expelled the pregnancy).