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  • Title: Controlled study of 16,16-dimethyl-trans-delta 2 prostaglandin E1 methyl ester vaginal pessaries prior to suction termination of first trimester pregnancies.
    Author: Fisher PR, Taylor JH.
    Journal: Br J Obstet Gynaecol; 1984 Nov; 91(11):1141-4. PubMed ID: 6388625.
    Abstract:
    A pessary containing the prostaglandin analogue, 16,16-dimethyl-trans-delta 2 prostaglandin E1 methyl ester (Cervagem) was inserted into the vagina of primigravid women 2 h before suction termination of pregnancy. The cervix was softer, easier to dilate and more widely dilated at the start of the procedure than in a control group of women who received placebo pessaries containing the vehicle alone. Intra-operative blood loss was diminished. The incidence of pre- and post-operative abdominal cramps was increased in the Cervagem-treated group. No gastrointestinal side-effects were noted. A case control study to assess the effect on the cervix of inserting a pessary containing the prostaglandin analogue, 16,16-dimethyl-trans-delta 2 prostaglandin E1 methyl ester (Cervagem), into the vagina 2 hours prior to suction curettage was undertaken at the National Woem's Hospital in Uckland, New Zealand. Previous investigaors found that pretreatment of the cervix with Cervagem 3 hours prior to termination reduced cervical damage by making it easier to dilate the cervix. In order to facilitate termination procedures in a busy outpatient clinic, the pesent investigation was undertaken to determine if the treatment time could be reduced to 2 hours and still be effective. The study group consisted of 110 consecutively admitted primigravid patients, aged 14-35, at 6-12 weeks gestation. A randomized supply of 55 placebo pessaries and 55 active pessaries containing 1 mg of Cervagem were inserted, and temperature, pluse, and blood pressure measurements were taken just prior to insertion and then hourly. Prior to termination the patients received an injection of 50-100 ug fentanyl and paracervical block of 10-20 ml of 1% lignocaine was used as a local anesthesia. An assessment of the ease of dilation was made just prior to the operation, and blood loss during the procedure was measured and recored. Chi-square and t-test techniques were used to anaylyze the data. Results indicated that the Cervagem treatment significantly increased the ease of dilation but that the degree proceeded the operation by 3 hours. Spkecific findings were: 1) the mean dilation just prior to termination was 5.8 mm in the Cervagem treated group and 4.9 mm in the control group; 2) mechanical dilation was requred for 49 of the treated women and for 54 of the controls, and the difference was significant (P0.05); 3) dilation was difficult or moderately difficult in 17 of the treated women and in 28 of the placebo patients, and this difference was significant (P0.02); and 4) blood loss during the operation was significantly less for the treated group than for the untreated group (P0.02). Preoperative side effects in the Cervagem treated group were more common than in the control group, but none of the effects were serious. Postoperative complaints of abdominal cramping were significantly more common among the treated patients than among the control (P0.001); however, there were no differences between the 2 groups in regard to the incidence of postoperative pain, nausea, or diarrhea.
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