Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Medical Abortion

Treatments: Drug: Mifepristone; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01856985

1010

Details and patient eligibility

About

These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively.

Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.

Enrollment: 50 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Seeking abortion services
• Have an intrauterine pregnancy 78 days through 84 days' LMP
• Be willing and able to sign consent forms
• Agree to comply with study procedures and visit schedule
• Be living with 30 minutes from the hospital

Exclusion criteria

• Does not meet the inclusion criteria outlined above

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Misoprostol at clinic

Experimental group

Description:

Eligible women will receive 200 mg mifepristone to be administered at home or at the clinic and will receive either 800 µg misoprostol buccally (study 1) or 800 µg misoprostol sublingually (study 2) to self administer at home. Participants will be asked to return to the hospital 14 days later for a follow-up visit.

Treatment:

Drug: Misoprostol

Drug: Mifepristone