Randomized trial of the effect of drugs on cervical dilatation for termination of first trimester pregnancy.

A randomized triple-blind and placebo-controlled clinical trial on the effect of lidocaine and Anodyne-lubricant jelly (ALJ) containing dicaine on cervical dilatation is reported. Three-hundred-seventy-two consecutive cases were randomly allocated to 4 groups. The four groups were given: ALJ and placebo (placebo 1); and lidocaine and placebo (placebo 2). ALJ and placebo 1 treatment was by topical application, and lidocaine and placebo 2 by injection. In parous women, a significant difference was found for satisfactory dilatation (SD) rate (p less than 0.01) among four groups. It was unexpected that there were no significant differences between drug and placebo groups, neither between ALJ treatment group and placebo 1 group (p greater than 0.5), nor between lidocaine and placebo 2 (p greater than 0.75). However, the combined SD rate was 60.9% for the topical groups compared with 39.0% for the injection groups (p less than 0.005). The findings suggested that the effect of ALJ on cervical dilatation was not mainly due to dicaine, but associated with the lubricant and the topical treatment.

RCT Entities:   Population Interventions Outcomes