Mechanical dilation of the cervix can be both difficult and dangerous and has potentially serious complications. Lamicel, a synthetic hydrophilic polymer, was inserted into the cervix between 2 and 24 h before termination by vacuum aspiration in the first trimester in 48 nulliparae. A control group of 12 nulliparae were not treated with Lamicel. The force needed to dilate the cervix, accurately measured with a specifically designed force-measuring instrument, was found to be significantly reduced in all treated groups. The greatest rate of dilatation occurred within the first 2 h after insertion.
PIP: The study objective was to investigate the effectiveness of a synthetic hydrophilic polymer used as a cervical osmotic dilator before vacuum aspiration in 1st trimester abortion. Lamicel is a polyvinyl alcohol polymer sponge impregnated with magnesium sulphate and compressed to form a thin cylindrical tent. When inserted into the endocervical canal and left in position the Lamicel absorbs and retains fluid from the cervical tissue because of its hygroscopic properties. In the process the Lamicel swells to 4 times its original diameter and is converted from a hard rigid tent into a soft sponge. 60 nullipara who were having vacuum termination of pregnancy in the 1st trimester at the Queen's Medical Center and City Hospital, Nottingham, UK, were recruited into the study. The patients were randomly allocated to 1 of 5 groups each composed of 12 patients. 4 of the groups were treated with Lamicel for various periods before abortion; the 5th group was not treated with Lamicel and constituted a control group. In the 4 treated groups the Lamicel was left in position for periods of 2, 6, 12, or 24 hours in groups 2, 3, 4, and 5, respectively, before abortion. In the control group (group 1) lamicel was not inserted. After insertion the patients were monitored for evidence of discomfort, uterine cramps, sepsis, syncope, or bleeding. These observations were continued for 24 hours after the operation. The patients ranged in age from 14-28 years and gestation at termination ranged from 10-13 weeks. A comparison of the pressure recordings of the control group with each of the treated groups showed a highly significant difference. The reduction of cervical resistance occurred mainly in the first 2 hours after insertion of the Lamicel. There was further reduction in resistance up to 6 hours, but the difference between groups 1 (2 hours) and 2 (6 hours) was not statistically significant, and there were no significant differences between any of the treated groups. Insertion of 5mm Lamicel was achieved without difficulty in 43 (90%) of the patients. A 3mm Lamicel was chosen for the remaining 5 patients because of cervical resistance encountered at the internal os. During insertion 16 patients (33%) experienced mild discomfort. This resolved spontaneously within 5 minutes. There were no problems associated with the removal of the tents and no other side effects were noted. There were no differences in the amount of blood lost during the operation or in the incidence of postoperative pain and bleeding between the 5 groups.