Randomised controlled trial comparing efficacy of same day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36- to 48-hour protocol.

HYPOTHESIS: That a 6-hour drug administration interval has similar efficacy and greater patient satisfaction as a 36- to 48-hour interval.

SAMPLE: Four hundred and fifty patients.

METHODS

A two-arm parallel design unblended randomised controlled trial in a single hospital. Eligible women up to 63 days of gestation will be invited to participate. Those willing will be randomised to either the experimental group (6 hours administration of misoprostol) or the control group (36-48 hours administration of misoprostol). All participants will take 200 mg mifepristone orally. At the time determined by study group allocation 800 microg misoprostol will be given intravaginally together with 100 mg diclofenac pr. Antibiotic prophylaxis as per the usual protocol will be given to each group. The control group will remain in hospital for 6 hours as per current policy and the study group will return home in 1 to 3 hours.

MAIN OUTCOME MEASURE: Complete medical abortion without need for further misoprostol or surgical evacuation.

SECONDARY OUTCOMES: Duration of bleeding, side effects and acceptability based on questionnaire.

FUNDING SOURCE: None.