A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

Gynuity Health Projects

Status: Completed

Conditions: Abortion, Induced

Treatments: Drug: 800 mcg misoprostol via oral or buccal administration

Study type: Interventional

Funder types: Other

Identifiers

NCT00386867

1.1.3

Details and patient eligibility

About

This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• be willing and able to sign consent forms;
• be eligible for medical abortion according to clinician's assessment;
• be willing to undergo a surgical completion if necessary;
• have ready and easy access to a telephone and emergency transportation;
• speak English, Spanish, or have a translator available to translate for all study procedures; and,
• agree to comply with the study procedures and visit schedule.

Exclusion criteria

• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
• IUD in place;
• Chronic renal failure;
• Concurrent long-term corticosteroid therapy;
• History of allergy to mifepristone, misoprostol or other prostaglandin;
• Hemorrhagic disorders or concurrent anticoagulant therapy;
• Inherited porphyrias; or
• Other serious physical or mental health conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)