Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone

Gynuity Health Projects

Status and phase

Completed

Phase 4

Conditions

Complete Abortion

Treatments

Drug: medical abortion

Study type

Interventional

Funder types

Other

Identifiers

NCT01387256

1.2.1

Details and patient eligibility

About

This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.

Enrollment

441 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Gestational age < 63 days since LMP, confirmed by ultrasound or clinical assessment.
General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
Able to consent to study participation.

Exclusion criteria

Gestational age > 63 days LMP
Confirmed or suspected ectopic or molar pregnancy
Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.