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Revista Brasileira de Ginecologia E... Jan 2019The gestational complication most associated with perinatal mortality and morbidity is spontaneous preterm birth with gestational age < 37 weeks. Therefore, it is... (Comparative Study)
Comparative Study Review
OBJECTIVE
The gestational complication most associated with perinatal mortality and morbidity is spontaneous preterm birth with gestational age < 37 weeks. Therefore, it is necessary to identify its risk factors and attempt its prevention. The benefits of the pessary in prematurity are under investigation. Our objective was to analyze the use of the pessary in the prevention of preterm births in published studies, and to compare its efficacy with other methods.
METHODS
Randomized clinical trials published between 2010 and 2018 were selected from electronic databases. Studies on multiple gestations were excluded.
RESULTS
Two studies were in favor of the pessary as a preventive method, one study was contrary to the method and another two showed no statistically significant difference. The meta-analysis showed no statistical difference with the use of a cervical pessary in the reduction of births < 37 (odds ratio [OR]: 0.63; confidence interval [95% CI]: 0.38-1.06) and < 34 weeks (OR: 0.74; 95% CI: 0.35-1.57) CONCLUSION: The pooled data available to date seems to show a lack of efficacy of the cervical pessary in the prevention of preterm birth, although the heterogeneity of the studies made comparisons more difficult.
Topics: Female; Humans; Pessaries; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30716786
DOI: 10.1055/s-0038-1676511 -
Journal of Applied Microbiology Jul 2016Treatment of vaginal infection requires different drugs although the recurrence rate post treatment remains high due to adverse effects on the beneficial microbiota.... (Review)
Review
Treatment of vaginal infection requires different drugs although the recurrence rate post treatment remains high due to adverse effects on the beneficial microbiota. Thus, there are clear clinical advantages for the use of biotherapeutic agents (prebiotics and/or probiotics) for treating these infections. Pre- and probiotic beneficial effects can be delivered topically or systemically. In general, both approaches have the potential to optimize, maintain and restore the ecology of the vaginal ecosystem. Specific carbohydrates provide a therapeutic approach for controlling infections by stimulating the growth of the indigenous lactobacilli but inhibiting the growth and adhesion of pathogens to the vaginal epithelial cells. Overall, little evidence exists to promote the prevention or treatment of vaginal disease with prebiotic carbohydrates in formulations such as pessaries, creams or douches. However, recent reports have promoted prebiotic applications in ecosystems other than the gut and include the mouth, skin and vagina. This review focuses on the utilization of pre- and probiotics for vaginal health.
Topics: Female; Humans; Lactobacillus; Microbiota; Prebiotics; Probiotics; Vaginal Diseases
PubMed: 26757173
DOI: 10.1111/jam.13054 -
The Cochrane Database of Systematic... May 2013Preterm birth is a major health problem and contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical... (Review)
Review
BACKGROUND
Preterm birth is a major health problem and contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical incompetence and multiple pregnancy. Different management strategies have been tried to prevent preterm birth, including cervical cerclage. Cervical cerclage is an invasive technique that needs anaesthesia and may be associated with complications. Moreover, there is still controversy regarding the efficacy and the group of patients that could benefit from this operation. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.
OBJECTIVES
To evaluate the efficacy of cervical pessary for the prevention of preterm birth in women with risk factors for cervical incompetence.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 September 2012), Current Controlled Trials and the Australian New Zealand Clinical Trials Registry (1 September 2012).
SELECTION CRITERIA
We selected all published and unpublished randomised clinical trials comparing the use of cervical pessary with cervical cerclage or expectant management for prevention of preterm birth. We did not include quasi-randomised trials. Cluster-randomised or cross-over trials were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion.
MAIN RESULTS
The review included one randomised controlled trial. The study included 385 pregnant women with a short cervix of 25 mm or less who were between 18 to 22 weeks of pregnancy. The use of cervical pessary (192 women) was associated with a statistically significantly decrease in the incidence of spontaneous preterm birth less than 37 weeks' gestation compared with expectant management (22% versus 59 %; respectively, risk ratio (RR) 0.36, 95% confidence interval (CI) 0.27 to 0.49). Spontaneous preterm birth before 34 weeks was statistically significantly reduced in the pessary group (6% and 27% respectively, RR 0.24; 95% CI 0.13 to 0.43). Mean gestational age at delivery was 37.7 + 2 weeks in the pessary group and 34.9 + 4 weeks in the expectant group. Women in the pessary group used less tocolytics (RR 0.63; 95% CI 0.50 to 0.81) and corticosteroids (RR 0.66; 95% CI 0.54 to 0.81) than the expectant group. Vaginal discharge was more common in the pessary group (RR 2.18; 95% CI 1.87 to 2.54). Among the pessary group, 27 women needed pessary repositioning without removal and there was one case of pessary removal. Ninety-five per cent of women in the pessary group would recommend this intervention to other people. Neonatal paediatric care admission was reduced in the pessary group in comparison to the expectant group (RR 0.17; 95% CI 0.07 to 0.42).
AUTHORS' CONCLUSIONS
The review included only one well-designed randomised clinical trial that showed beneficial effect of cervical pessary in reducing preterm birth in women with a short cervix. There is a need for more trials in different settings (developed and developing countries), and with different risk factors including multiple pregnancy.
Topics: Female; Gestational Age; Humans; Pessaries; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic
PubMed: 23728668
DOI: 10.1002/14651858.CD007873.pub3 -
Archives of Gynecology and Obstetrics Aug 2023Pelvic floor disorders are common and associated with pregnancy and childbirth. For restitution of pelvic floor connective tissue and thereby therapy of postpartum...
PURPOSE
Pelvic floor disorders are common and associated with pregnancy and childbirth. For restitution of pelvic floor connective tissue and thereby therapy of postpartum pelvic organ prolapse and stress urinary incontinence, the Restifem pessary is approved. It supports the anterior vaginal wall behind the symphysis, the lateral sulci and the sacro-uterine ligaments and stabilises the connective tissue. We evaluated the compliance and applicability of Restifem use in women postpartum in a preventive and therapeutic approach.
METHODS
Restifem pessary was handed out to 857 women. Six weeks after birth, they started the pessary use. After 8 weeks, 3 and 6 months postpartum, women received a questionnaire via online survey for evaluation of pessary applicability and efficacy.
RESULTS
After 8 weeks, 209 women answered the questionnaire. 119 women used the pessary. Common problems were discomfort, pain and the pessary use was to circuitous. Vaginal infections were rare. After 3 months, 85 women and after 6 months, 38 women still used the pessary. 3 months postpartum, 94% of women with POP, 72% of women with UI and 66% of women with OAB stated to have an improvement of their symptoms using the pessary. 88% women without any disorder felt an improvement of stability.
CONCLUSIONS
Use of the Restifem pessary in the postpartum period is feasible and accompanied with less complications. It reduces POP and UI and leads to an increased sense of stability. So, Restifem pessary can be offered to women postpartum to improve pelvic floor dysfunction.
Topics: Pregnancy; Female; Humans; Male; Pessaries; Pelvic Floor; Prospective Studies; Postpartum Period; Parturition; Pelvic Organ Prolapse
PubMed: 37210701
DOI: 10.1007/s00404-023-07075-9 -
BMJ Open Jul 2022Pelvic organ prolapse can be managed with a pessary. However, regular follow-up may deter women due to the inconvenience of frequent appointments, as well as preventing... (Review)
Review
OBJECTIVES
Pelvic organ prolapse can be managed with a pessary. However, regular follow-up may deter women due to the inconvenience of frequent appointments, as well as preventing autonomous decision making. Pessary self-management may be a solution to these issues. However, there remains a number of uncertainties regarding pessary self-management. This scoping review aims to map available evidence about pessary self-management to identify knowledge gaps providing the basis for future research.
DESIGN
Scoping review as detailed in the review protocol.
DATA SOURCES
A search of MEDLINE, CINAHL, EMBASE and PsycINFO databases and a handsearch were undertaken during May 2021 to identify relevant articles using the search terms 'pessary' and 'self-management' or 'self-care'.
DATA EXTRACTION AND SYNTHESIS
Data relevant to pessary self-management was extracted and the Mixed Methods Appraisal Tool used to assess empirical rigour. Thematic analysis was performed to evaluate the results.
RESULTS
The database search identified 82 publications. After duplicates and articles not meeting the inclusion and exclusion criteria were removed, there were 23 eligible articles. A hand search revealed a further 19 articles, resulting in a total of 42 publications.Findings relevant to pessary self-management were extracted and analysed for the emergence of themes. Recurrent themes in the literature were; the characteristics of self-managing women; pessary care; factors associated with decision making about self-management; teaching self-management and cost benefit.
CONCLUSIONS
Pessary self-management may offer benefits to some women without increased risk. Some women do not feel willing or able to self-manage their pessary. However, increased support may help women overcome this. Further in-depth exploration of factors which affect women's willingness to self-manage their pessary is indicated to ensure better understanding and support as available for other conditions.
Topics: Female; Humans; Pelvic Organ Prolapse; Pessaries; Self-Management
PubMed: 35851026
DOI: 10.1136/bmjopen-2021-060223 -
The Cochrane Database of Systematic... Dec 2022Preterm birth (PTB), defined as birth prior to 37 weeks of gestation, occurs in ten percent of all pregnancies. PTB is responsible for more than half of neonatal and... (Review)
Review
BACKGROUND
Preterm birth (PTB), defined as birth prior to 37 weeks of gestation, occurs in ten percent of all pregnancies. PTB is responsible for more than half of neonatal and infant mortalities and morbidities. Because cervical insufficiency is a common cause of PTB, one possible preventive strategy involves insertion of a cervical pessary to support the cervix. Several published studies have compared the use of pessary with different management options and obtained questionable results. This highlights the need for an up-to-date systematic review of the evidence.
OBJECTIVES
To evaluate the benefits and harms of cervical pessary for preventing preterm birth in women with singleton pregnancies and risk factors for cervical insufficiency compared to no treatment, vaginal progesterone, cervical cerclage or bedrest.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform to 22 September 2021. We also searched the reference lists of included studies for additional records.
SELECTION CRITERIA
We included published and unpublished randomised controlled trials (RCTs) comparing cervical pessary with no treatment, vaginal progesterone, cervical cerclage or bedrest for preventing PTB. We excluded quasi-randomised trials. Our primary outcome was delivery before 34 weeks' gestation. Our secondary outcomes were 1. delivery before 37 weeks' gestation, 2. maternal mortality, 3. maternal infection or inflammation, 4. preterm prelabour rupture of membranes, 5. harm to woman from the intervention, 6. maternal medications, 7. discontinuation of the intervention, 8. maternal satisfaction, 9. neonatal/paediatric care unit admission, 10. fetal/infant mortality, 11. neonatal sepsis, 12. gestational age at birth, 13. harm to offspring from the intervention 14. birthweight, 15. early neurodevelopmental morbidity, 15. late neurodevelopmental morbidity, 16. gastrointestinal morbidity and 17. respiratory morbidity.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for eligibility and risk of bias, evaluated trustworthiness based on criteria developed by the Cochrane Pregnancy and Childbirth Review Group, extracted data, checked for accuracy and assessed certainty of evidence using the GRADE approach.
MAIN RESULTS
We included eight RCTs (2983 participants). We included five RCTs (1830 women) in the comparison cervical pessary versus no treatment, three RCTs (1126 pregnant women) in the comparison cervical pessary versus vaginal progesterone, and one study (13 participants) in the comparison cervical pessary versus cervical cerclage. Overall, the certainty of evidence was low to moderate due to inconsistency (statistical heterogeneity), imprecision (few events and wide 95% confidence intervals (CIs) consistent with possible benefit and harm), and risk of performance and detection bias. Cervical pessary versus no treatment Cervical pessary compared with no treatment may reduce the risk of delivery before 34 weeks (risk ratio (RR) 0.72, 95% CI 0.33 to 1.55; 5 studies, 1830 women; low-certainty evidence) or before 37 weeks (RR 0.68, 95% CI 0.44 to 1.05; 5 studies, 1830 women; low-certainty evidence). However, these results should be viewed with caution because the 95% CIs cross the line of no effect. Cervical pessary compared with no treatment probably has little or no effect on the risk of maternal infection or inflammation (RR 1.04, 95% CI 0.87 to 1.26; 2 studies, 1032 women; moderate-certainty evidence). It is unclear if cervical pessary compared with no treatment has an effect on neonatal/paediatric care unit admission (RR 0.96, 95% CI 0.58 to 1.59; 3 studies, 1332 infants; low-certainty evidence) or fetal/neonatal mortality (RR 0.93, 95% CI 0.58 to 1.48; 5 studies, 1830 infants; low-certainty evidence) because the 95% CIs are compatible with a wide range of effects that encompass both appreciable benefit and harm. Cervical pessary versus vaginal progesterone Cervical pessary may reduce the risk of delivery before 34 weeks (RR 0.72, 95% CI 0.52 to 1.02; 3 studies, 1126 women; moderate-certainty evidence) or before 37 weeks (RR 0.89, 95% CI 0.73 to 1.09; 3 studies, 1126 women; moderate-certainty evidence), but we are uncertain of the results because the 95% CI crosses the line of no effect. The intervention probably has little or no effect on maternal infection or inflammation (RR 0.95, 95% CI 0.81 to 1.12; 2 studies, 265 women; moderate-certainty evidence). It is unclear if cervical pessary compared with vaginal progesterone has an effect on the risk of neonatal/paediatric care unit admission (RR 0.98, 95% CI 0.49 to 1.98; low-certainty evidence) or fetal/neonatal mortality (RR 1.97, 95% CI 0.50 to 7.70; 2 studies; 265 infants; low-certainty evidence) because the 95% CIs are compatible with a wide range of effects that encompass both appreciable benefit and harm. Cervical pessary versus cervical cerclage Only one very small study of 13 pregnant women contributed data to this comparison; the results were unclear.
AUTHORS' CONCLUSIONS
In women with a singleton pregnancy, cervical pessary compared with no treatment or vaginal progesterone may reduce the risk of delivery before 34 weeks or 37 weeks, although these results should be viewed with caution due to uncertainty around the effect estimates. There is insufficient evidence with regard to the effect of cervical pessary compared with cervical cerclage on PTB. Due to low certainty-evidence in many of the prespecified outcomes and non-reporting of several other outcomes of interest for this review, there is a need for further robust RCTs that use standardised terminology for maternal and offspring outcomes. Future trials should take place in a range of settings to improve generalisability of the evidence. Further research should concentrate on comparisons of cervical pessary versus cervical cerclage and bed rest. Investigation of different phenotypes of PTB may be relevant.
Topics: Female; Pregnancy; Humans; Pessaries; Cervix Uteri; Progesterone; Premature Birth; Cerclage, Cervical
PubMed: 36453699
DOI: 10.1002/14651858.CD014508 -
American Family Physician May 2010Pelvic organ prolapse, or genital prolapse, is the descent of one or more of the pelvic structures (bladder, uterus, vagina) from the normal anatomic location toward or...
Pelvic organ prolapse, or genital prolapse, is the descent of one or more of the pelvic structures (bladder, uterus, vagina) from the normal anatomic location toward or through the vaginal opening. Women of all ages may be affected, although pelvic organ prolapse is more common in older women. The cause is a loss of pelvic support from multiple factors, including direct injury to the levator ani, as well as neurologic injury from stretching of the pudendal nerves that may occur with vaginal childbirth. Previous hysterectomy for pelvic organ prolapse; ethnicity; and an increase in intra-abdominal pressure from chronic coughing, straining with constipation, or repeated heavy lifting may contribute. Most patients with pelvic organ prolapse are asymptomatic. A sense of bulging or protrusion in the vagina is the most specific symptom. Evaluation includes a systematic pelvic examination. Management options for women with symptomatic prolapse include observation, pelvic floor muscle training, mechanical support (pessaries), and surgery. Pessary use should be considered before surgery in women who have symptomatic prolapse. Most women can be fitted with a pessary regardless of the stage or site of predominant prolapse. Surgical procedures are obliterative or reconstructive.
Topics: Exercise; Female; Health Behavior; Health Knowledge, Attitudes, Practice; Humans; Muscle Contraction; Patient Education as Topic; Pelvic Organ Prolapse; Pessaries; Women's Health
PubMed: 20433127
DOI: No ID Found -
Frontiers in Medicine 2023Preterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on... (Review)
Review
BACKGROUND
Preterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on progesterone, cerclage, pessary, and acetylsalicylic acid (ASA) to prevent preterm birth in asymptomatic women with singleton pregnancies defined as risk of preterm birth and multifetal pregnancies.
METHODS
Six databases (including PubMed, Embase, Medline, the Cochrane Library) were searched up to February 2022. RCTs published in English or Scandinavian languages were included through a consensus process. Abstracts and duplicates were excluded. The trials were critically appraised by pairs of reviewers. The Cochrane risk-of-bias tool was used for risk of bias assessment. Predefined outcomes including preterm birth, perinatal/neonatal/maternal mortality and morbidity, were pooled in meta-analyses using RevMan 5.4, stratified for high and low risk of bias trials. The certainty of evidence was assessed using the GRADE approach. The systematic review followed the PRISMA guideline.
RESULTS
The search identified 2,309 articles, of which 87 were included in the assessment: 71 original RCTs and 16 secondary publications with 23,886 women and 32,893 offspring. Conclusions were based solely on trials with low risk of bias ( = 50).Singleton pregnancies: Progesterone compared with placebo, reduced the risk of preterm birth <37 gestational weeks: 26.8% vs. 30.2% (Risk Ratio [RR] 0.82 [95% Confidence Interval [CI] 0.71 to 0.95]) (high certainty of evidence, 14 trials) thereby reducing neonatal mortality and respiratory distress syndrome. Cerclage probably reduced the risk of preterm birth <37 gestational weeks: 29.0% vs. 37.6% (RR 0.78 [95% CI 0.69 to 0.88]) (moderate certainty of evidence, four open trials). In addition, perinatal mortality may be reduced by cerclage. Pessary did not demonstrate any overall effect. ASA did not affect any outcome, but evidence was based on one underpowered study.Multifetal pregnancies: The effect of progesterone, cerclage, or pessary was minimal, if any. No study supported improved long-term outcome of the children.
CONCLUSION
Progesterone and probably also cerclage have a protective effect against preterm birth in asymptomatic women with a singleton pregnancy at risk of preterm birth. Further trials of ASA are needed. Prevention of preterm birth requires screening programs to identify women at risk of preterm birth.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.uk/prospero/], identifier [CRD42021234946].
PubMed: 36936217
DOI: 10.3389/fmed.2023.1111315 -
American Family Physician Aug 2017
Topics: Female; Humans; Muscle Stretching Exercises; Pelvic Organ Prolapse; Pessaries; Risk Factors; Urinary Incontinence
PubMed: 28762699
DOI: No ID Found -
BJUI Compass Nov 2022Pessaries are desirable for its overall safety profiles. Serious complications have been reported; however, there is little summative evidence. This systematic review... (Review)
Review
INTRODUCTION
Pessaries are desirable for its overall safety profiles. Serious complications have been reported; however, there is little summative evidence. This systematic review aimed to consolidate all reported serious outcomes from pessaries usage to better identify and counsel patients who might be at higher risk of developing these adverse events.
METHODS
We performed a systematic literature review using search terms such as 'prolapse', 'stress urinary incontinence' and 'pessary or pessaries or pessarium' on PubMed, Embase and CINAHL. A total of 36 articles were identified. Patient-level data were extracted from case reports to further describe complications on an individual level.
RESULTS
Overall median age of the patients was 82 years (range 62-98). The most frequent complications were vesicovaginal fistula (25%, = 9/36), rectovaginal fistula (19%, = 7/36), vaginal impaction (11%, = 4/36) and vaginal evisceration of small bowel through vaginal vault (8%, = 3/36). In the vesicovaginal fistula cohort, none of the patients had a history of radiation, and two had histories of total abdominal hysterectomy (22%). In the rectovaginal fistula cohort, one patient had a history of pelvic radiation for rectal squamous cell carcinoma, and another had a history of chronic steroid use for rheumatoid arthritis. No other risk factors were reported in the other groups. Ring and Gellhorn were the most represented pessary types among the studies, 16 (44%) and 12 (33%), respectively. No complications were reported with surgical and non-surgical treatment of the complications.
CONCLUSION
Pessaries are a reasonable and durable treatment for POP with exceedingly rare reports of severe adverse complications. The ideal candidate for pessary should have a good self-care index. Studies to determine causative factors of the more serious adverse events are needed; however, this may be difficult given the long follow-up that is required.
PubMed: 36267197
DOI: 10.1002/bco2.174