Shaw KA, et al. – A randomised controlled trial is carried out to assess mifepristone as an adjunct to, or replacement for, osmotic dilators for cervical preparation in surgical abortion after 19–weeks gestation. The outcome of this study suggests elimination of osmotic dilators has the potential to reduce burden and opportunity cost of cervical preparation. The longer procedure time, identified with manual dilation, is offset by decreasing dilator–related pre–operative time and discomfort. Provider experience may affect risk when eliminating dilators.

Methods

• For this study, they designed a site–stratified, double–blinded randomised controlled trial.
• This study was conducted at two tertiary care teaching hospitals.
• Between November 2013 through November 2015, women undergoing dilation and evacuation (D&E) at 19–23 plus 6/7 weeks gestation were included in this study.
• In this study, all the participants were randomised to receive (1) mifepristone alone (n=27), (2) osmotic dilators with mifepristone (n=27), or (3) osmotic dilators with placebo (n=21) with all receiving pre–procedure misoprostol.

Results

• Total 75 participants were enrolled in this study. 21–weeks was the mean gestation for this study.
• In this study, pre–procedure cervical dilation was ≥ 3cm in 4%, 52%, and 57% of participants in groups (1), (2) and (3), respectively (p<0.005).
• Mifepristone with misoprostol for cervical preparation resulted in longer procedure times than osmotic dilators with median total procedure times of (1) 18.5 (8–52), (2) 12 (7–25), and (3) 13 (6–26) minutes (p=<0.005).
• Excluding time required for manual dilation, procedure times were similar: median times from dilation complete to evacuation complete were (1) 10.5 (4–23), (2) 8.5 (5–24), and (3) 10 (4–20) minutes (p=0.10).
• Complications occurred in 7 cases, 6 with trainees and one with an attending (p=0.03), with no difference by study group (p=0.12).