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American Journal of Obstetrics &... May 2024Preterm birth is a major cause of perinatal morbidity and mortality. It is unclear whether the introduction of a universal transvaginal ultrasound cervical length... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Preterm birth is a major cause of perinatal morbidity and mortality. It is unclear whether the introduction of a universal transvaginal ultrasound cervical length screening program in women at low risk for preterm delivery is associated with a reduction in the frequency of preterm birth.
OBJECTIVE
To test the hypothesis that the introduction of a midtrimester universal transvaginal ultrasound cervical length screening program in asymptomatic singleton pregnancies without prior preterm delivery would reduce the rate of preterm birth at <37 weeks of gestation.
STUDY DESIGN
This study was a multicenter nonblinded randomized trial of screening of asymptomatic singleton pregnancies without prior spontaneous preterm birth, who were randomized to either cervical length screening program (ie, intervention group) or no screening (ie, control group). Participants were randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks of gestation. Women randomized in the screening group received cervical length measurement. Those who were found to have cervical length ≤25 mm were offered 200 mg vaginal progesterone daily along with cervical pessary. The primary outcome was preterm birth at <37 weeks. The risk of primary outcome was quantified by the relative risk with 95% confidence interval, and was based on the intention-to-screen principle.
RESULTS
A total of 1334 asymptomatic women with singleton pregnancies and without prior preterm birth, were included in the trial. Out of the 675 women randomized in the transvaginal ultrasound cervical length screening group, 13 (1.9%) were found to have transvaginal ultrasound cervical length ≤25 mm during the screening. Preterm birth at <37 weeks of gestation occurred in 48 women in the transvaginal ultrasound cervical length screening group (7.5%), and 54 women in the control group (8.7%) (relative risk, 0.86; 95% confidence interval, 0.59-1.25). Women randomized in the transvaginal ultrasound cervical length screening group had no significant differences in the incidence of preterm birth at less than 34, 32, 30, 28, and 24 weeks of gestation.
CONCLUSION
The introduction of a universal transvaginal ultrasound cervical length screening program at 18 0/6 to 23 6/7 weeks of gestation in singleton pregnancies without prior spontaneous preterm birth, with treatment for those with cervical length ≤25 mm, did not result in significant lower incidence of preterm delivery than the incidence without the screening program.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Risk; Cervix Uteri; Incidence
PubMed: 38642994
DOI: 10.1016/j.ajogmf.2023.101267 -
Archives of Gynecology and Obstetrics Jun 2024There is no evidence about the efficacy of self-care of vaginal pessary in women with symptomatic pelvic organ prolapse (POP). The aim of this systematic review and... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
There is no evidence about the efficacy of self-care of vaginal pessary in women with symptomatic pelvic organ prolapse (POP). The aim of this systematic review and meta-analysis is to assess the adherence to pessary treatment among women who engage in self-management of their pessary.
METHODS
We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected seven publications for inclusion in the analysis.
RESULTS
Pooled continuation rate of self-cared vaginal pessary was the 76% (95%CI: 66-85%) with a I-test of 93.3% (p < 0.001). Pooled conversion to POP surgery was the 12% (95%CI: 1-23%) with a I-test of 96% (p < 0.001). Continuation rate was not statistically different between women who were treated by self-care and non-self-care management of vaginal pessary (RR 1.11, 95%CI 0.96-1.27; p = 0.15), with a related I-test of 37% (p = 0.21).
CONCLUSION
Self-care vaginal pessary management presented a high continuation rate in women affected by pelvic organ prolapse at a long follow-up. The rate of conversion to surgical management of POP was low. No significant difference in continuation rate were highlighted between women who adopted the self-care or the clinical-based management of pessary.
Topics: Humans; Pelvic Organ Prolapse; Pessaries; Female; Self Care; Patient Compliance; Treatment Outcome
PubMed: 38634900
DOI: 10.1007/s00404-024-07506-1 -
International Journal of Gynaecology... Apr 2024Prediction of pregnancies at risk of preterm birth (PTB) may allow targeted prevention strategies. (Review)
Review
BACKGROUND
Prediction of pregnancies at risk of preterm birth (PTB) may allow targeted prevention strategies.
OBJECTIVES
To assess quality of clinical practice guidelines (CPGs) and identify areas of agreement and contention in prediction and prevention of spontaneous PTB.
SEARCH STRATEGY
We searched for CPGs regarding PTB prediction and prevention in asymptomatic singleton pregnancies without language restriction in January 2024.
SELECTION CRITERIA
CPGs included were published between July 2017 and December 2023 and contained statements intended to direct clinical practice.
DATA COLLECTION AND ANALYSIS
CPG quality was assessed using the AGREE-II tool. Recommendations were extracted and grouped under domains of prediction and prevention, in general populations and high-risk groups.
MAIN RESULTS
We included 37 CPGs from 20 organizations; all were of moderate or high quality overall. There was consensus in prediction of PTB by identification of risk factors and cervical length screening in high-risk pregnancies and prevention of PTB by universal screening and treatment for asymptomatic bacteriuria, screening and treatment for BV in high-risk pregnancies, and use of preventative progesterone and cerclage. Areas of contention or limited consensus were the role of PTB clinics, universal cervical length measurement, biomarkers and cervical pessaries.
CONCLUSIONS
This review identified strengths and limitations of current PTB CPGs, and areas for future research.
PubMed: 38619379
DOI: 10.1002/ijgo.15514 -
European Journal of Obstetrics &... Jun 2024We aimed to identify the incidence and risk factors of spontaneous preterm birth in pessary carriers with singleton pregnancies and a short cervix in the mid-trimester...
INTRODUCTION
We aimed to identify the incidence and risk factors of spontaneous preterm birth in pessary carriers with singleton pregnancies and a short cervix in the mid-trimester of pregnancy.
MATERIAL AND METHODS
Patient data were obtained from the PECEP Trial. We analyzed singleton pregnancies in pessary carriers with a short cervix (≤25 mm) between 18 and 22 gestational weeks. Demographics and obstetric history were compared to identify risk factors for spontaneous preterm birth < 34 gestational weeks. Each demographic and obstetric variable was compared between spontaneous preterm birth < 34 and ≥ 34 weeks of gestation.Regression analysis was used to identify risk factors. A risk score model was generated using the odds ratio for significant factors. The risk score model and spontaneous preterm birth risk were assessed using the receiver operating characteristic curve. Perinatal outcomes were compared by risk score.
RESULTS
Among 190 pregnant individuals, 12 (6.3%) had spontaneous preterm birth < 34 gestational weeks. In the bivariate analysis, statistically significant differences between those with and without spontaneous preterm birth were only observed for mean cervical length at diagnosis and mean cervical length after pessary placement. By multiple logistic regression analysis, maternal age (OR 0.818; 95% CI 0.69-0.97; 0.020), cervical length at diagnosis (OR 0.560; 95% CI 0.43-0.73; < 0.001) and smoking status (OR 7.276; 95% CI 1.02-51.80; 0.048) remained significantly associated with spontaneous preterm birth.The ROC curve from the multiple logistic regression analysis, including cervical length, maternal age and smoking status, had an area under the curve (AUC) of 0.952 0.001). The ROC curve for the risk score model incorporating all three variables had an AUC of 0.864 (95% CI 0.77-0.96; < 0.001). A high-risk score was predictive of spontaneous preterm birth with a sensitivity of 75%, specificity of 84%, positive predictive value of 24%, and negative predictive value of 98%.Women with a high-risk score had a significantly reduced latency to delivery and poorer neonatal outcomes than those with a low-risk score.
CONCLUSIONS
Patients at a high risk for spontaneous preterm birth despite pessary therapy may be identified using cervical length at diagnosis added to maternal age and smoking status.
PubMed: 38595705
DOI: 10.1016/j.eurox.2024.100305 -
Cureus Mar 2024Preterm birth is the delivery of a live fetus before the 37th week of gestation. Preterm birth may stem from various factors, including premature rupture of membranes,... (Review)
Review
Preterm birth is the delivery of a live fetus before the 37th week of gestation. Preterm birth may stem from various factors, including premature rupture of membranes, spontaneous preterm labor, or medically induced circumstances. Premature delivery can result in serious and long-lasting difficulties even for infants who survive, as it is the leading cause of death for infants under five years old. Numerous nations have implemented initiatives to detect and track pregnant women who may give birth before their due date. Numerous therapies are available to protect these at-risk groups from the devastating effects of premature delivery, given the complex nature of preterm birth risk factors. Among the preventive measures, prophylactic progesterone appears to hold significant promise, while cervical cerclage proves effective in cases of cervical insufficiency. Conversely, pessaries show no discernible beneficial effects in reducing the risk of preterm birth. Regular antenatal visits are imperative for frequent patient evaluation and screening for potential risk factors. Adopting a healthy lifestyle can influence the risk of developing preeclampsia, with regular physical activity, a fiber-rich diet, and smoking cessation serving to mitigate the risk of preterm birth. The efficacy of bed rest in preventing preterm birth remains inconclusive due to insufficient evidence. This study aims to explore various preventive strategies for averting premature birth in high-risk women.
PubMed: 38586732
DOI: 10.7759/cureus.55737 -
Maturitas Jul 2024The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of... (Clinical Trial)
Clinical Trial
OBJECTIVES
The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause.
STUDY DESIGN
Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial.
MAIN OUTCOME MEASURES
During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied.
RESULTS
A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as "good to very good" by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred.
CONCLUSION
Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active.
CLINICALTRIALS
gov identifier NCT05211505.
Topics: Humans; Female; Middle Aged; Vaginal Diseases; Quality of Life; Aged; Prospective Studies; Dyspareunia; Vagina; Menopause; Pessaries; Surveys and Questionnaires; Severity of Illness Index; Postmenopause; Treatment Outcome
PubMed: 38583316
DOI: 10.1016/j.maturitas.2024.107978 -
BMJ Case Reports Apr 2024Vaginal pessaries are widely considered to be a safe and effective non-surgical management option for women with pelvic organ prolapse. Complications may occur, and are...
Vaginal pessaries are widely considered to be a safe and effective non-surgical management option for women with pelvic organ prolapse. Complications may occur, and are more frequent with improper care and certain device designs and materials. It is imperative to provide information to patients about potential complications. We present the case of a woman in her 70s who presented to the Emergency Department with increasing groin and abdominal pain following a vaginal pessary insertion 2 days prior for grade 3 vaginal vault prolapse. On presentation, her abdomen was markedly distended with guarding. Laboratory investigations showed a significant acute kidney injury with a metabolic acidosis. An initial non-contrast CT showed fluid and inflammatory changes surrounding the bladder, and bladder perforation was suspected. A subsequent CT cystogram showed extravasation of contrast from the bladder into the peritoneal cavity, in keeping with an intraperitoneal bladder rupture. The patient underwent an emergency bladder repair in theatre.
Topics: Humans; Female; Pessaries; Urinary Bladder; Pelvic Organ Prolapse; Urinary Bladder Diseases; Vagina; Abdominal Injuries
PubMed: 38569734
DOI: 10.1136/bcr-2023-257233 -
Urogynecology (Philadelphia, Pa.) Mar 2024ChatGPT (Chat Generative Pre-trained Transformer) is an artificial intelligence (AI) chatbot that provides human-like responses to text prompts. Little is known...
IMPORTANCE
ChatGPT (Chat Generative Pre-trained Transformer) is an artificial intelligence (AI) chatbot that provides human-like responses to text prompts. Little is known regarding ChatGPT's ability to identify original research ideas in urogynecology.
OBJECTIVE
Our objective was to evaluate the accuracy of ChatGPT in generating novel systematic review (SR) and research ideas in urogynecology.
STUDY DESIGN
In this cross-sectional study, we asked ChatGPT to generate 10 novel SR ideas that have not yet been published for each of the following 5 topics: (1) urogynecology, (2) tension-free vaginal tape slings, (3) pessaries for pelvic organ prolapse, (4) beta-3 agonist use for overactive bladder, and (5) sexual function with genitourinary syndrome of menopause. Research idea novelty was assessed by cross-referencing PubMed and Scopus to determine if any prior publications existed.
RESULTS
ChatGPT proposed 50 total SR ideas, including 10 for each prompt. Overall, ChatGPT showed 54% overall accuracy in developing novel SR ideas. Nonnovel SR ideas had a median of 19 (interquartile range, 8-35) published SRs on the suggested topic. When stratified by prompt type, 50% of general and 40-70% of specific urogynecology proposed SR ideas were found to be novel. There were no publications of any type identified for 7 of the 50 suggested ideas.
CONCLUSIONS
ChatGPT may be helpful for identifying novel research ideas in urogynecology, but its accuracy is limited. It is essential for those using ChatGPT to review existing literature to ensure originality and credibility. As AI transforms health care, we encourage all urogynecologists to familiarize themselves with popular AI platforms.
PubMed: 38527167
DOI: 10.1097/SPV.0000000000001505 -
Value in Health : the Journal of the... Jul 2024Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation.
METHODS
A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period.
RESULTS
There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%.
CONCLUSIONS
Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.
Topics: Humans; Pessaries; Cost-Benefit Analysis; Pelvic Organ Prolapse; Quality-Adjusted Life Years; Female; Middle Aged; Aged; Decision Support Techniques; Self-Management; Models, Economic
PubMed: 38492924
DOI: 10.1016/j.jval.2024.03.004 -
Clinics (Sao Paulo, Brazil) 2024Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION AND HYPOTHESIS
Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women.
METHODS
This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment.
RESULTS
The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044).
CONCLUSIONS
The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.
Topics: Female; Humans; Middle Aged; Pelvic Organ Prolapse; Pessaries; Pilot Projects; Postmenopause; Quality of Life; Treatment Outcome; Aged
PubMed: 38484583
DOI: 10.1016/j.clinsp.2024.100335