The Extended Gestational Age Medical Abortion Study

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Medical Abortion

Treatments: Drug: Mifepristone and misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00997347

1.2.2

Details and patient eligibility

About

This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.

Enrollment: 1,400 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• intrauterine pregnancy of greater than 56 days and less than 71 days
• eligible for medical abortion according to study doctor assessment
• willing and able to sign consent forms
• speak English or Spanish (in US sites); speak the local language(s) (in international sites)
• agree to comply with the study procedures and visit schedule

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

64-70 days' gestational age

Experimental group

Description:

Women whose pregnancies are estimated to have a gestational age of 64-70 days

Treatment:

Drug: Mifepristone and misoprostol

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.)