DOUBLE-BLIND COMPARISON OF INTRACERVICAL AND INTRAVAGINAL PROSTAGLANDIN E(2) FOR CERVICAL RIPENING AND INDUCTION OF LABOR

OBJECTIVE: Our purpose was to compare the safety and effectiveness of prostaglandin E(2) delivered sequentially as an intracervical (0.5 mg) or intravaginal (2.5 mg) gel. STUDY DESIGN: Hospitalized patients wit h an unfavorable cervix (Bishop score less than or equal to 4) at grea ter than or equal to 35 weeks and requiring induction of labor were as signed to receive two 2.5 mi doses of gel intracervically and intravag inally in a double-blind, placebo-controlled manner. Second and third doses were given at 6-hour intervals until there were either regular u terine contractions or a Bishop score change >3 points. RESULTS: The 1 00 evaluable cases received prostaglandin E(2) either intracervically (n = 52) or intravaginally (n = 48). Difficulty with exact gel instill ation was present with intracervical gel only, where spillage occurred in 85% of cases. Compared with intracervical therapy prostaglandin E( 2) given intravaginally was more likely to significantly change the Bi shop score (60.4% vs 40.4%, p = 0.04) and stimulate regular contractio ns (72.9% vs 48.1%, p = 0.01). Uterine hyperstimulation was present in one case in each group. CONCLUSION: Although each was safe, instillat ion of prostaglandin E(2) gel was better at a higher intravaginal dose than a lower intracervical dose because of its greater ease of admini stration and higher likelihood of cervical change.