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Controlled study comparing vaginal prostaglandin E2 pessaries with intravenous oxytocin for the stimulation of labour after spontaneous rupture of the membranes.

In a prospective randomized study, 36 patients with spontaneous rupture of the membranes of greater than or equal to 4 h duration were stimulated with 3 mg vaginal prostaglandin E2 pessaries or intravenous oxytocin. Oxytocin stimulation was associated with shorter labours and a lower incidence of abnormal cervimetric progress. Of the patients given prostaglandin pessaries, 40% required a second dose after 4 h for slow progress; 45% of the primigravidae subsequently developed abnormal labour which was corrected by augmentation with oxytocin in all cases. One caesarean section was carried out for disproportion, and the remaining 35 patients were delivered vaginally. Prostaglandin pessaries were not associated with an increased incidence of hyperstimulation or sepsis. In conclusion, although PGE2 pessaries are safe in spontaneous rupture of the membranes, intravenous oxytocin is more efficient in stimulating labour.

Adolescent↗

The use of 16,16-dimethyl-trans delta 2 prostaglandin E1 methyl ester (gemeprost) vaginal pessaries for the termination of pregnancy in the early second trimester. A comparison with extra-amniotic prostaglandin E2.

The use of gemeprost pessaries has been compared in an open randomized trial with the extra-amniotic infusion of prostaglandin E2 (PGE2) for the termination of pregnancy between 12 and 16 weeks gestation. The success rates were 77% and 79% for the pessary and infusion group respectively, and these rates were unaffected by parity. There was no significant difference in the cumulative abortion rate between the two groups, nor were there differences in the induction-abortion interval, nor in the time taken to the onset of pain or bleeding. However, women in the pessary group required significantly less analgesia than those in the infusion group. Side-effects, experienced both during treatment and during the 6 weeks after abortion, were similar in both groups. Gemeprost vaginal pessaries are an effective alternative to the extra-amniotic infusion of PGE2 for the termination of pregnancy in the early second trimester.

Abortion, Induced↗

Oestradiol-releasing vaginal ring versus oestriol vaginal pessaries in the treatment of bothersome lower urinary tract symptoms.

OBJECTIVES: To assess the efficacy of an oestradiol-releasing vaginal ring and oestriol pessaries in the alleviation of lower urinary tract symptoms occurring after the menopause. DESIGN: Randomised, parallel group, controlled trial. SETTING: Twenty-six clinics of practising gynaecologists and one outpatient clinic at a department of obstetrics and gynaecology. POPULATION: Two hundred and fifty-one postmenopausal women, with a mean age of 66 years, reporting at least one bothersome lower urinary tract symptom. METHODS: One hundred and thirty-four women were treated with the oestradiol-releasing ring for 24 weeks; 117 women were treated with oestriol pessaries 0.5 mg every second day for 24 weeks. MAIN OUTCOME MEASURES: Subjective scores of urgency, frequency, nocturia, dysuria, stress incontinence and urge incontinence. RESULTS: The two treatments were equally efficacious in alleviating urinary urgency (51% vs 56%), urge incontinence (58% vs 58%), stress incontinence (53% vs 59%) and nocturia (51% vs 54%). Dysuria was alleviated in 76% vs 67%, equivalence was not demonstrated. No statistically significant difference was found for any primary efficacy endpoint. Sixty percent of the participants rated the form of administration via the vaginal ring as excellent, compared with 14% for the pessaries (P < 0.0001). CONCLUSIONS: Low dose vaginally administered oestradiol and oestriol are equally efficacious in alleviating lower urinary tract symptoms which appear after the menopause. The form of administration of the vaginal ring, seems to be more acceptable than oestriol pessaries.

Administration, Intravaginal↗

Induction of labour in nulliparas with poor cervical score: oxytocin or prostaglandin vaginal pessaries?

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.

Adult↗

Cervical ripening before induction of labour in patients with an unfavourable cervix: a comparative randomized study of the Atad Ripener Device, prostaglandin E2 vaginal pessary, and prostaglandin E2 intracervical gel.

One hundred and nineteen women with singleton pregnancy and cephalic presentation requiring induction of labour in the presence of an unfavourable cervix (Bishop score < or = 4) were studied. Five patients were excluded because of failure to comply with the protocol. Cervical ripening was carried out using 3 different methods; 36 used the Atad Ripener Device, 39 received 0.5 mg PGE2 intracervical gel and 39 received at least one 3 mg PGE2 intravaginal pessary. There were no differences in the demographic characteristics and the indications for induction. Five patients developed complications during the ripening period necessitating intervention; 3 required emergency Caesarean section and 2 delivered vaginally. Although statistically there were no differences among the 3 methods of cervical ripening, the power of the study is probably not large enough to show the differences. The PGE2 pessary appears to be more effective with 68% of patients either going into labour during cervical ripening or succeeding in the cervical ripening compared to around 50% in the Atad and PGE2 gel groups. The vaginal delivery rate was 87.2% in the pessary group compared to 72.2% in the Atad group and 84.6% in the gel group. The duration of labour was also shorter in the pessary group with 73.5% delivered within 24 hours compared to 57.7% in the Atad group and 57.6% in the gel group. Although the results of the Atad device seem to be inferior, the risk of uterine hyperstimulation from the use of the device is probably lower than that of the PGE2 and may therefore be preferable in women with fetuses at high risk of fetal hypoxia.

Adult↗

Pessaries in the geriatric patient.

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.

Age Factors↗

The use of povidone-iodine ('Betadine') pessaries in the treatment of candidal and trichomonal vaginitis.

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.

Candidiasis, Vulvovaginal↗

Forgotten vaginal pessary eroding into rectum.

Vaginal pessaries still have a role in the management of uterine prolapse, particularly in elderly patients. However, they are known to cause serious complications if proper care is not taken. We present a case of a rectovaginal fistula, developing secondary to a forgotten vaginal pessary. The shelf pessary was found to have eroded through into the rectum. A review of the relevant literature was undertaken and complications associated with vaginal pessaries are discussed.

Aged, 80 and over↗

Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix?

OBJECTIVE: The purpose was to determine the effect of vaginal pessaries in patients at risk for spontaneous preterm birth (SPB). STUDY DESIGN: Transvaginal sonography (TVS) was longitudinally performed to measure cervical length (CL) in 258 singleton at risk for SPB and 282 twin pregnancies. Pairs with or without treatment were matched for gestational age and the CL at examination. RESULTS: In 4 singleton and 7 twin pregnancies the CL was < 15 mm before 24 weeks, the mean interval between pessary insertion and delivery was 13 + 2 and 12 + 5 weeks respectively. For the matched control analysis, 12 pairs with singleton and 23 pairs with twin pregnancies were compared. For singleton pregnancies, the mean interval between TVS and delivery was 99 (70-134) days in the treatment and 67 (2-130) days in the control group (p = 0.0184), the mean gestational age at delivery was 38 (36 + 6-41) and 33 + 4 (26-38) weeks respectively (p = 0.02). For twin pregnancies, the interval was 85 (43-129) days in the treatment and 67 (21-100) days in the control group (p = 0.001), gestational age at delivery was 35 + 6 (33-37 + 4) and 33 + 2 (24 + 4-37 + 2) respectively (p = 0.02). Within singleton pregnancies with pessary, there was no SPB < 36 weeks compared to 6/12 cases in the control group (p < 0.001). Within twin pregnancies, the rates were 8/23 cases with SPB < 36 weeks but none < 32 weeks, compared to 12/23 cases with SPB < 36 weeks and 7/23 cases < 32 weeks in the control group (p < 0.001). CONCLUSIONS: Insertion of a vaginal pessary may be a cost-effective preventive treatment in patients at risk for SPB. Prospective controlled trials are needed.

Adult↗

Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India.

BACKGROUND & OBJECTIVES: Though nonoxynol-9 (N-9) is available in India as a spermicidal pessary, data on its safety as a potential microbicide among Indian women are not available. Nonoxynol-9 containing compounds have shown anti-HIV activity in in vitro studies and protection against cervical infections. Nonoxynol-9 is being extensively evaluated as a vaginal microbicide world-wide. We assessed the safety and preliminary acceptability of nonoxynol-9 pessary as a vaginal microbicide in women at low risk for human immunodeficiency virus (HIV) infection and sexually transmitted diseases (STDs). METHODS: Twenty three HIV seronegative women enrolled in the study were given Today pessarys containing 5 per cent of nonoxynol-9 for vaginal use at bedtime for 14 days. Colposcopy was done at enrollment and on day 14 and speculum examination on day 7 to assess the local toxicity. RESULTS: Most of the women (16/23, 69.6%) did not experience any symptoms of genital irritation. The remaining 7 (30.4%, 95% CI 11.6-49.2) women reported 11 episodes of mild irritative symptoms of short duration. On clinical examination, three adverse events were reported of which one could have been product related. Eight (34.8%) women showed willingness to use the product for protection against HIV transmission if it was approved. INTERPRETATION & CONCLUSION: Nonoxynol-9 vaginal pessary was found to be safe and acceptable in once daily dose in low risk women after consecutive use for 14 days. Willingness for future use, if found safe and effective for HIV prevention was shown by 8 (34.8%) women.

Administration, Intravaginal↗

[Comparison of cerclage and cerclage pessary in the treatment of pregnant women with incompetent cervix and threatened preterm delivery].

UNLABELLED: Cervical incompetence is one of the causes of preterm delivery. Ultrasound examination of the cervix has given the evidence that cervical shortening, dilatation of internal cervical os and funneling observed long before term are the warning signs of preterm delivery. Early diagnosis and treatment may serve better outcome. Cerclage, which has been employed for more than 50 years is a traumatic procedure, furthermore requiring anaesthesia. Cerclage pessary can be a safe alternative to cerclage. This method seems to be less invasive. The aim of the study was to compare the effectiveness of the two methods employed in gravid patients between 22 and 27 completed weeks of pregnancy with clinically and ultrasonographically confirmed shortening of the cervix. MATERIAL AND METHODS: We analysed 57 patients, 22 treated with McDonald cerclage procedure and 35 with pessary. The primary outcome measure was prolongation of pregnancy--mean 13.4 weeks and 12.1 weeks for cerclage and pessary respectively (p = 0.06). There were no significant differences regarding the mode of delivery, rate of prematurity, mean birthweight and Apgar score. CONCLUSIONS: Cerclage and cerclage pessary are equally effective methods of prolongation of pregnancy in gravid patients with incompetent cervix and threatened preterm labor. The choice of the method does not affect the mode of delivery as well as neonatal outcome.

Adult↗

Pessary test in women with urinary incontinence.

Thirty women with urinary incontinence underwent detailed preoperative and postoperative clinical and urodynamic evaluation before and after the pessary test. The urodynamic changes observed with the pessary test (P less than .01) were very similar to those seen after corrective incontinence surgery. The pessary test differentiated patients with bladder instability from those complaining of stress urinary incontinence with a correctable anatomic defect. Pre- and postpessary test voiding urethrocystometry and uroflometry demonstrated absence of urethral obstruction to the free flow of urine. The pessary test is a simple, inexpensive, reliable diagnostic and prognostic tool. It simulates the results of anticipated incontinence surgery and restores continence without causing compression of the urethra as does the Bonney test.

Adult↗

Investigation of the efficacy of progesterone pessaries in the relief of symptoms of premenstrual syndrome. progesterone Study Group.

BACKGROUND: A variety of definitions have been applied to premenstrual syndrome. The severity of the syndrome is also variable. AIM: A study was undertaken to compare progesterone pessaries with placebo in the relief of symptoms of premenstrual syndrome. In this study the condition was characterized by a wide range of symptoms recurring in the late luteal phase but absent in the follicular phase (that is, the specific definition published by Dalton in 1953). METHOD: A multicentre, prospective, double-blind, randomized, parallel group study was undertaken by 45 general practitioners. Patients were deemed eligible after two prospective menstrual cycles of observation (selection phase) in which a precise definition of symptoms was applied. Patients were randomized to use either progesterone pessaries (400 mg twice a day) or matching placebo, by vaginal or rectal administration, from 14 days before the expected onset of menstruation until the onset of vaginal bleeding, for four consecutive cycles. Baseline data for the outcome variables were determined in the selection phase. The main outcome variables were changes in the severity (categorized as none, mild, moderate or severe) of each patient's most severe symptom, and in the average score of all the patient's symptoms characteristic of premenstrual syndrome. Spontaneous reports of adverse events were recorded. RESULTS: A total of 281 patients were screened for premenstrual syndrome; of these, 141 patients were randomized to treatment or placebo groups. Efficacy was evaluated in 93 patients. Reductions in the scores of the highest scoring, most severe, symptoms and in the average symptom score, were consistently observed in patients receiving progesterone pessaries and in those receiving placebo. The response to progesterone was greater than to placebo during each cycle; the differences were clinically and statistically significant. Adverse events were reported by 51% of patients in the progesterone treatment group and by 43% in the placebo group. Irregularity of menstruation, vaginal pruritus and headache were reported more frequently by patients taking active therapy. CONCLUSION: In this study, progesterone, given as pessaries by vaginal or rectal administration, was more effective than placebo in the relief of symptoms of premenstrual syndrome in a population of patients selected by strict entry criteria.

Adolescent↗

A comparison of oral misoprostol tablets and vaginal prostaglandin E2 pessary in induction of labour at term.

OBJECTIVE: To compare the cost-effectiveness, mode of delivery, fetal and maternal outcome of oral Misoprostol and vaginal prostaglandin E2 pessary in induction of labour at term. DESIGN: Randomized clinical trial. PLACE AND DURATION OF STUDY: Hamdard University Hospital, Imam Clinic and General Hospital from February 2002 to January 2003. PATIENTS AND METHODS: The trial was conducted over two groups of patient for labour induction such that Group A received 50 microg oral Misoprostol 4 hourly to a maximum of four doses. Group B received prostaglandin E2 vaginal pessary at 6 hourly intervals upto two doses. Labour induction, number of doses, need of augmentation, induction to delivery time interval, mode of delivery and neonatal outcome were the main outcomes. Test of proportions was used to compare the significance between both managements. RESULTS: Out of a total of 214 women, 106 received oral Misoprostol and 108 received PGE2 vaginal pessary. Ninety-three percent women in misoprostol group were successfully induced compared with 91% in PGE2 group. A significant response of labour induction with the minimal dose (58%, p = 0.001) and earlier induction to vaginal delivery (74%, p = 0.01) was observed in Misoprostol group. Rate of operative delivery was also less (16%, p = 0.16) compared with PGE2 group (25%). CONCLUSION: Oral Misoprostol administration was more efficient and cost-effective than PGE2 vaginal pessary for induction of labour due to earlier response with minimal dose and less number of operative deliveries.

Administration, Intravaginal↗

Systemic absorption of ketoconazole from vaginal pessaries.

Eight healthy female subjects were each given (a) ketoconazole 400 mg orally, (b) ketoconazole 400 mg as a single vaginal pessary, (c) ketoconazole 800 mg as two vaginal pessaries, and (d) ketoconazole 1200 mg as three vaginal pessaries. The area under the plasma concentration time curve (AUC) after the oral dose was 51.41 +/- 10.99 mg l-1 h (mean +/- s.d.) and the half-life of ketoconazole was 2.98 +/- 1.41 h. The AUCs after vaginal administration were 0.27 +/- 0.14, 0.52 +/- 0.25, and 0.43 +/- 0.22 mg-1 l h following the 400, 800 and 1200 mg pessaries respectively. Systemic absorption of single doses of vaginally administered ketoconazole appears to be negligible in the absence of vaginal infection. There were no local or systemic side effects related to ketoconazole in these healthy volunteers.

Absorption↗

Maternal plasma bicycling PGE2 levels following vaginal administration of prostaglandin E2 pessaries in full term pregnancies.

Plasma levels of bicyclic PGE2 (PGE2M) were measured after administration of a 5mg, PGE2 slow release hydrogel pessary and a 3mg vaginal tablet (Upjohn). Twenty-four women of low parity with favourable induction features were randomised to receive either the hydrogel pessary or the vaginal tablet. A single pessary was administered and amniotomy was performed after 4 hours. Augmentation with oxytocin was carried out after amniotomy if required. Both groups showed a rise in plasma PGE2 levels in keeping with the release profiles of the pessaries. Wide interindividual differences in absorption were found.

Administration, Intravaginal↗

[Intrauterine pessaries and acute genital inflammation in women].

The performed clinic-statistical investigation has covered generally 2182 patients, 946 patients of common group make use of intrauterine contraceptive pessaries and 1236 patients have been included on the other occasion. Generally 14 832 menstrual cycles were followed up. There were used multivariational method and analysis for investigation of three and more risk factors at once. The essential connection between the presence of intrauterine pessary and increased risk of sharply inflammation of the genital apparatus had been established. The uterus was the most often affected--endometritis in sharp and chronic from in 31.39% of cases, and in 3 cases pelvioperitonitis was diagnosed. The appearance of genitals inflammation under the pessary presence is connected also with the age, parity, the application time and the pessary use.

Adult↗

Serial changes in the biophysical profile in patients undergoing cervical ripening with a controlled release PGE2 vaginal pessary.

OBJECTIVE: The purpose of this study was to evaluate the effects of exogenous administration of PGE2 upon the components of the biophysical profile. METHODS: The study group included 17 nulliparas at > or = 38 weeks gestation, with a Bishop score of < or = 4, requiring induction of labor. A controlled release vaginal pessary containing 10 mg of PGE2, designed to release hormones at approximately 0.8 mg per hour in vitro, was used for 12 hours of cervical ripening. The BPP was performed by the same sonographer at three intervals: prior to pessary insertion, at 6 hours, and 12 hours. RESULTS: None of these patients had membrane rupture or went into spontaneous labor during the ripening process. All patients subsequently required amniotomy and oxytocin. The proportion of patients scoring 2 points for fetal breathing movements decreased from 59% at baseline to 0% at 12 hours, P < 0.0005, and the proportion of patients with fetal body movements decreased from 100% at baseline to 25% at 12 hours, P < 0.0005. However, the other components of the biophysical profile were not affected. The mean maternal plasma PGE2 metabolite concentrations were 235 pg/ml, 475 pg/ml, and 466 pg/ml at 0, 6 and 12 hours, respectively, P < 0.005. CONCLUSIONS: In term patients, vaginal administration of the PGE2 pessary was associated with improved Bishop score over 12 hours and significant increases in maternal plasma PGEM levels at 6 hours and 12 hours. These changes were inversely related to fetal breathing and body movements.

Administration, Intravaginal↗