Lamicel versus laminaria for cervical dilation before early second-trimester abortion: a randomized clinical trial.
Lamicel is a synthetic osmotic cervical dilator reported to work within two hours. To evaluate its efficacy and side effects, we conducted a double-blind, randomized clinical trial comparing Lamicel with multiple laminaria for cervical dilation in 219 patients before second-trimester abortion. A single Lamicel produced significantly less initial dilation (two-tailed P value = .03) than did multiple laminaria, but the techniques had comparable degrees of difficulty in subsequent dilation to 43 French units (two-tailed P value greater than .05) and rates of achieving dilation of 43 French units with rigid dilators (relative risk 1.0; 95% confidence interval 0.9-1.1). Lamicel removal resulted in a significantly lower rate of bleeding from the os (relative risk 0.3; 95% confidence interval 0.2-0.5). Because of its greater convenience, lower cost per patient, and comparable efficacy, Lamicel appears to be an attractive alternative to multiple laminaria for cervical dilation before abortion at 14-16 menstrual weeks' gestation.
D000028:Abortion, Induced / Q000379:methods*; D000293:Adolescent; D000328:Adult; D001672:Biocompatible Materials; D002584:Cervix Uteri / Q000502:physiology; D002986:Clinical Trials as Topic; D004106:Dilatation / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007795:Laminaria; D008278:Magnesium Sulfate / Q000008:administration & dosage* / Q000009:adverse effects; D011142:Polyvinyl Alcohol / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D011262:Pregnancy Trimester, Second; D011897:Random Allocation; D012624:Seaweed
D001672:Biocompatible Materials; C034860:Lamicel; D008278:Magnesium Sulfate; D011142:Polyvinyl Alcohol