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During 1986-1988, the Arabin-cerclage pessary was used alternatively to surgical cerclage in 58 patients for prophylactic and in 44 cases of therapeutic indications. In 5 additional patients, the pessary was applied instead of emergency cerclage. The advantages of the cerclage pessary compared to other rigid pessary types, are based on its flexibility and adjustment to the anatomic conditions of vagina and cervix. The bowl-shaped pessary is inserted with the curvature upwards and the cervix is fixed in the central opening of the cerclage pessary. Thus a constriction, reconfiguration, and elongation of the incompetent cervix is obtained as evidenced by ultrasonography. The only side effect of the pessary treatment is an increase in cervical secretion and subsequent vaginal discharge. No infectious complications occurred. In 92% of the treated gravidae the cerclage pessary could be removed after the 36th week of gestation. Cerclage pessary can be recommended as a favourable alternative to surgical procedures as prophylactic or therapeutic approach, reducing surgical treatment significantly to less than 0.5%.
The purpose of this randomized, double-blind study was to evaluate the efficacy and safety of a new controlled-release hydrogel pessary for ripening the cervix and initiating labor. Subjects had an entry Bishop score of 4 or less and gestational age of 37 or more weeks. One hundred fourteen women received a placebo pessary and 101 received the hydrogel pessary, containing 10 mg of prostaglandin (PG) E2. Compared with the placebo group, those given the PGE2 pessary were more likely to have an increase in Bishop score of 3 or more (60 or 59% versus 21 or 18%; P less than .0001), change to a Bishop score of 6 or higher (59 or 58% versus 18 or 16%; P less than .0001), and active labor (68 or 67% versus 15 or 13%; P less than .0001). Including the crossover study, uterine hyperstimulation (28 of 182, 15%) and fetal heart rate abnormalities (18 of 182, 10%) in PGE2-treated subjects were reversed on removal of the pessary with no apparent harm to the mother or fetus. These temporary adverse effects appeared while the pessary was in place and after the onset of active labor. Oxytocin was unnecessary in 89 of 182 (49%) of the PGE2-treated cases and was used more often to augment than to induce labor. We conclude that the described controlled-release PGE2 vaginal pessary induces appreciable cervical ripening and frequently initiates active labor with little or no need for oxytocin. The pessary may cause uterine hyperstimulation or fetal heart rate abnormalities, but these would be expected to reverse on removal of the pessary.
Prostaglandin E and F metabolite (PGEM and PGFM) concentrations in peripheral plasma were assayed following the vaginal administration of a controlled release hydrogel polymer pessary designed to release 0.6 mg PGE2 per hour in vivo. A linear relationship between calculated PGE2 release from the pessary and PGEM levels was observed with a correlation coefficient of 0.78. A significant rise in PGEM levels occurred two hours following pessary administration, with significantly higher PGEM levels in patients delivering within the eight hour observation period compared with those delivering later. PGFM levels increased more slowly. The results suggest that PGE2 released by the pessary crosses the vaginal epithelium and may stimulate endogenous prostaglandin production. The controlled rise of metabolites in association with the polymer pessary suggest that it should provide greater control in labour induction than other vehicles we have studied, but this should be confirmed by clinical trials.
To investigate the best route of prostaglandin medication for induction of labor, 125 pregnant women with unfavorable cervices (Bishop scores less than or equal to 6) were randomized to induction of labor with either PGE2 (0.5 mg) in a viscous intracervical gel once daily or PGE2 pessaries (2.5 mg) 1-2 a day. As estimated by life table analysis, the pessaries were significantly more effective inducing vaginal delivery compared to intracervical gel (24 h: P less than 0.025, 48 h: P less than 0.01, logrank test) and vaginal delivery was obtained within 24 h/48 h in 50%/72% of the women in the pessary group and in 29%/55% of the women in the intracervical group. Cervical ripening was found within 3 h (P less than 0.001) and in the subsequent 3 to 24 h period (P less than 0.005) after both treatments, no difference being found between the groups. The pessaries were much more effective inducing regular contractions compared to the intracervical gel (P less than 0.005, logrank test), so the latter seems preferable if cervical ripening rather than induction is intended. No difference was found analyzing the active labor period. No difference was found in methods of delivery, neonatal parameters (Apgar scores, umbilical artery blood pH and standard base excess), and the patients' attitude towards both methods of induction were equally favorable.
In a previous study nulliparas with poor cervical score (less than 5 out of 10) had a 43.5% Caesarean section (CS) rate of which 55% were for failed induction when labour was induced by artificial rupture of membranes and oxytocin infusion. In this study induction of labour by 2 doses of 3 mg prostaglandin E2 (PGE2) vaginal pessaries, 4 hours apart, and if necessary by artificial rupture of membranes and oxytocin infusion 24 hours later, resulted in a CS rate of 23.7% of which 38.9% were for failed induction. The latter regimen resulted in a significantly lower CS rate compared with labour induced by oxytocin infusion and rupture of membranes without the use of prostaglandins (p less than 0.001). In the prostaglandin group 53.3% were established in labour within 24 hours of inserting the pessary and in these patients the CS rate was 18.5%. In those who did not start labour and needed rupture of membranes and oxytocin infusion 24 hours after the first pessary, 34 (47.9%) had a good cervical score (greater than or equal to 6 out of 10) and 37 (52.1%) had a poor cervical score (less than or equal to 5 out of 10) at the time of amniotomy. The CS rates in these groups were 8.8% and 48.6% respectively (p less than 0.001). In nulliparas with poor cervical score induction is better performed with vaginal prostaglandin pessaries in order to reduce the high CS rate associated with artificial rupture of membranes and oxytocin infusion.
Pessaries have been used for centuries in the management of uterine prolapse. Although surgical repair has been popularized by surgeons and gynecologists for younger women with pelvic relaxation, pessaries remain a useful palliative strategy for patients who refuse surgery or represent higher operative risks. Despite the fact that pessaries are commonly used today, there is scant geriatric literature to describe their use among elderly patients. This article will review the indications and management of pessaries among elderly women with the goal of preventing complications and promoting investigation for their clinical application.
One hundred and thirty-five women suffering from trichomonal, candidal, or both infections simultameously, were treated with povidone-iodine pessaries, 2 pessaries being inserted nightly. Ninety-nine women were given a 7-day course of treatment, but the results obtained were disappointing, and the authors do not recommend such a regime for routine treatment. Better results were obtained with the recommended 14-day course. A further 36 women suffering from chronic trichomonal and/or canidal infections which had previously resisted orthodox treatment were given a prolonged 28-day course of pessary treatment. The results obtained were very encouraging, 92% of the trichomonal and 96% of the canidal infections being cured. Furthermore, although povidone-iodine is slightly less effective in trichomoniasis, most patients suffering from a chronic infection (candidal, as well as trichomonal) were cured by the one preparation. Side-effects did occur, but were significant in only 3 patients. Subjective symptoms, especially any offensive odour, disappeared within 3 days of the start of the treatment. The authors recommend that the 28-day course of povidone-iodine pessaries is used in those cases where trichomoniasis or candidosis has been a therapeutic problem in the past, particularly if the patient is currently on the oral contraceptive pill.
From 1967 to 1990, 96 previously untreated patients with cervicovaginal cancer associated with a history of vaginal pessary use to control uterovaginal prolapse were referred to eight radiation therapy departments in France. Sixty-eight patients had cervical cancer, and 28 had vaginal cancer. The mean interval between pessary insertion and cancer diagnosis was 18 years, with a range of 1 to 41 years. Most patients received radiation therapy and brachytherapy. Few (5%) had Grade 3 treatment side effects. The overall 5-year relative survival rate was 54%; nonsurvival was related to locoregional recurrence. Because almost all tumors occurred at the site of pessary insertion, foreign body chronic inflammation in association with viral infection may be the cause of the tumors.
A case of neglected pessary is presented. After erosion through the anterior vaginal and bladder walls the device came to rest entirely within the bladder. Surgical management of removal of the pessary and repair of the resulting vesicovaginal fistula are described. Appropriate use of supportive pessaries as well as complications of misuse and neglect are discussed.
PGE1 analogue (gemeprost) vaginal pessaries administered three hourly for three doses has been compared with a single extra- or intra-amniotic injection of PGE2 for mid-trimester termination of pregnancy in 450 women between 13 and 20 weeks gestation. The mean (SD) induction-abortion interval (IAI) in the vaginal pessary group of 19.5 (8.4) h was significantly longer than the respective intervals of 14.4 (9.3) and 16.1 (6.8) h in the patients treated extra- or intra-amniotically (P less than 0.001). Seventy-three percent treated with gemeprost aborted within 24 h of initial treatment compared with 84% and 87%, respectively in the extra- and intra-amniotic groups (P less than 0.05). Patients treated with gemeprost were more likely to need further prostaglandin treatment and had an increased incidence of gastrointestinal side effects. Despite these differences vaginal gemeprost pessaries provide a safe, effective, easy to administer method for midtrimester termination of pregnancy.
Twenty five patients booked for induction of labour, at 38 weeks or more gestation, were administered a controlled release vaginal polymer pessary containing 10 mg prostaglandin E2 (PGE2), designed to release 0.6 mg per hour in vivo. The release profile from the polymer was linear throughout the eight hour observation period with a correlation coefficient of 0.81, and regression slope of 0.93 mg/hr. with 95% confidence intervals of 0.63 mg/hr. to 1.23 mg/hr. This compared with a concomitant release profile in vitro which was uniform with time for the first five hours, but then continued at a decreasing rate with a correlation coefficient of 0.98. The relationship between PGE2 release and cervical score change was linear, with a correlation coefficient of 0.65. The results show that PGE2 release from the pessary in vivo is predictable, and suggest that the controlled release pessary offers the advantages of greater control of cervical ripening than alternative vehicles currently available.
Vaginal pessaries are useful for treating uterine prolapse when surgical intervention is not a safe option. This article covers recommendations for selection, insertion and care of the appliance. Careful follow-up is necessary to minimize possible complications, which can include infection, ulceration of the mucosa, incarceration of the pessary, and an increased incidence of vaginal and cervical malignancy. Disagreement within the literature about the proper schedule for follow-up, and inadequate documentation of the risks of pessary usage underscore the need for clinical research in this area.
Outpatient terminations were performed on 100 ultrasonographically confirmed pregnancies of less than or equal to 63 days with a single oral dose of RU 38,486 (600 mg) and a single vaginal pessary of 16,16-dimethyl-trans-delta 2-prostaglandin E1 (1 mg) 48 hours later. Abortion occurred in all patients; in 95 it was complete, in four it was incomplete, and one resulted in a missed abortion. In 88% the abortion occurred within 4 hours of prostaglandin treatment. A total of 25% of patients had nausea and 15% vomited after RU 38,486 treatment. After prostaglandin-treatment, 13% vomited, 10% had diarrhea, and 23% required administration of an opiate analgesic agent. No patient was transfused and there was no genital tract trauma; one case of suspected pelvic infection occurred. If the need for termination arose again, 88% would elect to use the method again, 9% would not. The combination of the antiprogestin RU 38,486 and a vaginal prostaglandin pessary appears to offer a safe, efficient, acceptable nonsurgical outpatient method of termination. Further studies on dosage and treatment protocols would be justified.
OBJECTIVE: The purpose of this study was to determine if prostaglandin E2 in a controlled-release vaginal pessary can produce cervical ripening at term. STUDY DESIGN: This was a double-blind, randomized, placebo-controlled study conducted at a university center and involving 81 patients with 42 receiving active agent. Categoric data were analyzed by Pearson's chi 2 or logistic regression. Continuous variables were analyzed by analysis of variance and the F test. RESULTS: Prostaglandin E2 was significantly better than placebo at cervical ripening and at decreasing the time to rupture of membranes, the time to onset of labor, the need to give oxytocin, and the time to vaginal delivery. Multiparous women benefitted more than primiparous ones. The cesarean section rate decreased only for multiparous women. Uterine hyperstimulation occurred only with prostaglandin E2 and after the onset of labor. CONCLUSIONS: Prostaglandin E2, when administered in a controlled-release vaginal pessary, is affective in producing cervical ripening at term. This agent should be used on inpatients who are under continuous monitoring and it should be removed at the onset of labor.
This study represents the first of its kind in Kuwait. Two preparations of prostaglandin E2 (PGE2) have been compared as agents for induction of labor. In a randomized controlled study of 200 women of low parity and unfavorable cervical induction features induction of labor by means of a single vaginal tablets of PGE2 was compared with locally prepared PGE2 vaginal pessaries. The gradual increase of uterine contractions and the establishment of labor in a similar way to that observed during spontaneous labor was more apparent after PGE2 tablets. Labor induction was successful in 80% of patients in PGE2 tablet group compared with 59% in PGE2 pessaries group. The incidence of cesarean section was equal in both groups (4%), but none was performed due to uterine hyperactivity. The data presented indicate that the PGE2 vaginal tablet is safe and effective in induction of labor in healthy women at term.
Efficacy of a two dose schedule of 3 mg pessary or 1700 micrograms film of PGE2 for induction of labour was compared in nulliparae with poor cervical score. Patient characteristics in the two groups (43 in 3 mg and 40 in 1700 micrograms group) were comparable in age, period of gestation, indications for induction of labour and in their initial cervical score. The number of patients who started labour with a two dose schedule 4 hours apart were similar in each group. The improvement of cervical score, length of labour, mode of delivery and the neonatal outcome were not different in the two groups. There was no advantage of using a film preparation over that in the form of a pessary and the use of 3 mg dose did not give significantly better results compared with the 1700 micrograms dose, in terms of obstetric or neonatal outcome.
Vaginal pessaries containing 3 mg of prostaglandin E2 were used to induce labour in 200 patients with variable induction features. Prostaglandin-induced labour was augmented where necessary by synthetic oxytocin. There was on failed induction. Only 23% of patients with favourable induction features and 53% of patients with unfavourable features needed oxytocin. There were no adverse fetal or maternal effects. The prostaglandin E2 pessary was as effective in inducing labour as 350 microgram extra-amniotic prostaglandin E2 in tylose in a comparable group of 200 patients in which there were 4 failed inductions.