An evaluation of informed consent prior to epidural analgesia for labor and delivery.

This investigation was performed to determine the ability of a parturient to recall the pre-anesthesia discussion with her anesthesiologist and to determine if written consent added to this discussion improves recall. Eighty-two women presenting in labor were randomized to 'verbal' and 'verbal plus written' consent for epidural labor analgesia and were contacted 5 to 7 months after a pre-anesthetic interview. Ten objective questions were posed at this time that addressed issues that were 'true risks', 'false risks', and 'situational' issues related to the consent process. These responses were scored on a point scale so that a maximal objective recall score of 100 points was possible. Median recall score was 80 (70-90) in the 'verbal' group and 90 (80-100) in the 'verbal plus written' group. This difference was statistically significant (P< 0.01). In addition, three subjective questions were asked of all women at this time. All but six women (one 'verbal plus written' and five 'verbal' group patients) expressed that written consent would help them 'remember and appreciate the different anesthetic options, risks, and procedures'. Four of these same women (one 'verbal plus written' and three 'verbal' group patients) thought a written consent process was 'alarming'. Two of these same women (both 'verbal' group patients) reported that they felt unable to give informed consent.

RCT Entities:   Population Interventions Outcomes