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European Journal of Obstetrics,... Jul 2024To evaluate the prediction performance of E-Cervix™ for preterm birth in twin pregnancies with threatened preterm labor.
OBJECTIVE
To evaluate the prediction performance of E-Cervix™ for preterm birth in twin pregnancies with threatened preterm labor.
METHODS
This was a single-center retrospective cohort study of twin pregnancies presenting to obstetrics triage for threatened preterm labor (PTL) between 23 0/7 - 33 6/7 weeks who received screening for PTL with transvaginal ultrasound cervical length (TVU CL) and cervical elastography with E-Cervix™ at the time of triage. Cervical elastography parameters were examined and compared between women who delivered preterm and those who did not. The quantification of cervical strain was calculated by a data analysis system that directly analyzes raw data from the region of interest (ROI) and described as hardness ratio (HR), mean strain level within 1 cm from internal (IOS) and external (EOS) os.
RESULTS
63 twin gestations without prior preterm birth and with threatened PTL between 23 0/7 - 33 6/7 weeks of gestation were included in the study. 27 (42.9 %) had cervical length < 25 mm, and were admitted for true PLT. Out of the 36 women with cervical length ≥ 25 mm, 6 (16.7 %) were admitted. Women with threatened PTL had significantly higher HR compared to those with true PTL (p < 0.01), and significantly lower IOS and EOS. Women who delivered preterm had significantly higher HR compared to those who did not delivery preterm and significantly lower IOS and EOS, in overall cohort, and in the subset of women with true PTL. Incidences of HR < 50 % and < 35 % were statistically significantly higher in women who delivered preterm compared to those who did not (p < 0.01).
CONCLUSION
Cervical elastography with E-Cervix™ may be useful for assessment of twin gestations presenting to obstetrics triage for threatened PTL.
Topics: Humans; Female; Pregnancy; Pregnancy, Twin; Retrospective Studies; Adult; Cervix Uteri; Elasticity Imaging Techniques; Premature Birth; Obstetric Labor, Premature; Cervical Length Measurement; Predictive Value of Tests
PubMed: 38739982
DOI: 10.1016/j.ejogrb.2024.05.001 -
The Cochrane Database of Systematic... May 2024Prenatal ultrasound is widely used to screen for structural anomalies before birth. While this is traditionally done in the second trimester, there is an increasing use... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Prenatal ultrasound is widely used to screen for structural anomalies before birth. While this is traditionally done in the second trimester, there is an increasing use of first-trimester ultrasound for early detection of lethal and certain severe structural anomalies.
OBJECTIVES
To evaluate the diagnostic accuracy of ultrasound in detecting fetal structural anomalies before 14 and 24 weeks' gestation in low-risk and unselected pregnant women and to compare the current two main prenatal screening approaches: a single second-trimester scan (single-stage screening) and a first- and second-trimester scan combined (two-stage screening) in terms of anomaly detection before 24 weeks' gestation.
SEARCH METHODS
We searched MEDLINE, EMBASE, Science Citation Index Expanded (Web of Science), Social Sciences Citation Index (Web of Science), Arts & Humanities Citation Index and Emerging Sources Citation Index (Web of Science) from 1 January 1997 to 22 July 2022. We limited our search to studies published after 1997 and excluded animal studies, reviews and case reports. No further restrictions were applied. We also screened reference lists and citing articles of each of the included studies.
SELECTION CRITERIA
Studies were eligible if they included low-risk or unselected pregnant women undergoing a first- and/or second-trimester fetal anomaly scan, conducted at 11 to 14 or 18 to 24 weeks' gestation, respectively. The reference standard was detection of anomalies at birth or postmortem.
DATA COLLECTION AND ANALYSIS
Two review authors independently undertook study selection, quality assessment (QUADAS-2), data extraction and evaluation of the certainty of evidence (GRADE approach). We used univariate random-effects logistic regression models for the meta-analysis of sensitivity and specificity.
MAIN RESULTS
Eighty-seven studies covering 7,057,859 fetuses (including 25,202 with structural anomalies) were included. No study was deemed low risk across all QUADAS-2 domains. Main methodological concerns included risk of bias in the reference standard domain and risk of partial verification. Applicability concerns were common in studies evaluating first-trimester scans and two-stage screening in terms of patient selection due to frequent recruitment from single tertiary centres without exclusion of referrals. We reported ultrasound accuracy for fetal structural anomalies overall, by severity, affected organ system and for 46 specific anomalies. Detection rates varied widely across categories, with the highest estimates of sensitivity for thoracic and abdominal wall anomalies and the lowest for gastrointestinal anomalies across all tests. The summary sensitivity of a first-trimester scan was 37.5% for detection of structural anomalies overall (95% confidence interval (CI) 31.1 to 44.3; low-certainty evidence) and 91.3% for lethal anomalies (95% CI 83.9 to 95.5; moderate-certainty evidence), with an overall specificity of 99.9% (95% CI 99.9 to 100; low-certainty evidence). Two-stage screening had a combined sensitivity of 83.8% (95% CI 74.7 to 90.1; low-certainty evidence), while single-stage screening had a sensitivity of 50.5% (95% CI 38.5 to 62.4; very low-certainty evidence). The specificity of two-stage screening was 99.9% (95% CI 99.7 to 100; low-certainty evidence) and for single-stage screening, it was 99.8% (95% CI 99.2 to 100; moderate-certainty evidence). Indirect comparisons suggested superiority of two-stage screening across all analyses regarding sensitivity, with no significant difference in specificity. However, the certainty of the evidence is very low due to the absence of direct comparisons.
AUTHORS' CONCLUSIONS
A first-trimester scan has the potential to detect lethal and certain severe anomalies with high accuracy before 14 weeks' gestation, despite its limited overall sensitivity. Conversely, two-stage screening shows high accuracy in detecting most fetal structural anomalies before 24 weeks' gestation with high sensitivity and specificity. In a hypothetical cohort of 100,000 fetuses, the first-trimester scan is expected to correctly identify 113 out of 124 fetuses with lethal anomalies (91.3%) and 665 out of 1776 fetuses with any anomaly (37.5%). However, 79 false-positive diagnoses are anticipated among 98,224 fetuses (0.08%). Two-stage screening is expected to correctly identify 1448 out of 1776 cases of structural anomalies overall (83.8%), with 118 false positives (0.1%). In contrast, single-stage screening is expected to correctly identify 896 out of 1776 cases before 24 weeks' gestation (50.5%), with 205 false-positive diagnoses (0.2%). This represents a difference of 592 fewer correct identifications and 88 more false positives compared to two-stage screening. However, it is crucial to acknowledge the uncertainty surrounding the additional benefits of two-stage versus single-stage screening, as there are no studies directly comparing them. Moreover, the evidence supporting the accuracy of first-trimester ultrasound and two-stage screening approaches primarily originates from studies conducted in single tertiary care facilities, which restricts the generalisability of the results of this meta-analysis to the broader population.
Topics: Female; Humans; Pregnancy; Bias; Congenital Abnormalities; Pregnancy Trimester, First; Pregnancy Trimester, Second; Sensitivity and Specificity; Ultrasonography, Prenatal
PubMed: 38721874
DOI: 10.1002/14651858.CD014715.pub2 -
Translational Andrology and Urology Apr 2024Patients with cystocele of pelvic organ prolapse quantification (POP-Q) stage II and below can be treated conservatively, but there are few reports on non-surgical...
BACKGROUND
Patients with cystocele of pelvic organ prolapse quantification (POP-Q) stage II and below can be treated conservatively, but there are few reports on non-surgical treatment for these patients. This study aimed to present the real-world clinical effectiveness of nonsurgical treatment, including pelvic floor muscle training (PFMT), PFMT combined with pessary (PFMT + P), or non-ablative radiofrequency (PFMT + RF) for female with POP-Q stage II cystocele.
METHODS
We retrospectively analyzed females with POP-Q stage II cystocele between January 2020 and January 2022 who received PFMT, PFMT + P, or PFMT + RF treatment and were followed up for 12 months. Clinical parameters including Pelvic Floor Distress Inventory-20 questionnaire (PFDI-20), Persian version urinary incontinence quality of life questionnaire (I-QOL), POP-Q, pelvic floor Glazer evaluation, and trans-labial ultrasound at different time points were analyzed.
RESULTS
There were 147 participants enrolled. PFDI-20 and I-QOL scores were improved in all groups, but the mean decrement in the PFDI-20 scores (-14.28±8.57 and -9.78±8.25) was higher in the PFMT + P group than in the PFMT group and PFMT + RF group at both 6 and 12 months (P<0.05), and the mean I-QOL score (3.82±23.43 and 3.47±22.06) was higher in the PFMT + RP group at both 6 months and 12 months (P<0.05). The PFMT + P group also showed higher improvement rate (43.3%, P=0.03) in terms of changing the severity of cystocele (point Ba) and delta bladder neck-symphyseal distance (ΔBSD) (P<0.05) than the other 2 groups at 12 months. No statistical difference was found in the type-I and type-II myofiber function-based Glazer assessment among 3 groups.
CONCLUSIONS
The combination of 2 treatment strategies seems to be superior to PFMT only for stage-II cystocele. Specific prolapse-related symptoms and objective indicators did improve more in the PFMT + P group, whereas stress urinary incontinence (SUI) symptoms and quality of life were improved in the PFMT + RP group.
PubMed: 38721295
DOI: 10.21037/tau-23-486 -
Urogynecology (Philadelphia, Pa.) May 2024The importance of this study was to examine treatment patterns and surgical complications for stress urinary incontinence (SUI).
IMPORTANCE
The importance of this study was to examine treatment patterns and surgical complications for stress urinary incontinence (SUI).
OBJECTIVES
The aim of this study was to describe the treatment of SUI and associated complications in a racially and ethnically diverse population.
STUDY DESIGN
This was a retrospective cohort study of patients with a new diagnosis of SUI. We identified patients who received treatment with a pessary, pelvic floor physical therapy, or surgery. Surgical complications were abstracted. Logistic regression was used to examine the association between race/ethnicity and treatment, as well as surgical complications.
RESULTS
A total of 67,187 patients with a new diagnosis of SUI were included. The population was predominately Hispanic (47.5%) followed by White, Asian, Black, Native Hawaiian/Pacific Islander, and American Indian/Alaska Native. Comparing no treatment to any treatment, all racial/ethnic groups, except American Indian/Alaska Native, had decreased odds of receiving treatment compared with White women. Hispanic and Native Hawaiian/Pacific Islander women had increased odds of referral for pelvic floor physical therapy compared with White women. All racial/ethnic groups, except for American Indian/Alaska Native women, had decreased odds of receiving a sling procedure compared with White women. When these racial/ethnic minority groups did receive treatment, it was more likely to be conservative treatment compared with White women. There were no significant differences in individual surgical complications.
CONCLUSIONS
Racial minority women were 20-50% less likely to undergo a sling procedure, commonly posited as the gold standard surgical treatment. Racial minority women were 40-100% more likely to receive conservative management and 20-50% less likely to receive any treatment compared with White women.
PubMed: 38710019
DOI: 10.1097/SPV.0000000000001525 -
BMJ Open May 2024To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.
OBJECTIVE
To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.
DESIGN
Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.
SETTING
21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.
PARTICIPANTS
1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.
INTERVENTIONS
Pessary therapy and surgery.
PRIMARY AND SECONDARY OUTCOME MEASURES
The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.
RESULTS
For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives.
CONCLUSIONS
Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.
TRIAL REGISTRATION NUMBER
NTR4883.
Topics: Humans; Pessaries; Female; Cost-Benefit Analysis; Pelvic Organ Prolapse; Middle Aged; Netherlands; Aged; Quality-Adjusted Life Years; Treatment Outcome; Quality of Life
PubMed: 38692718
DOI: 10.1136/bmjopen-2023-075016 -
Medicina (Kaunas, Lithuania) Mar 2024Pelvic organ prolapse (POP) is a common condition in women, with its prevalence increasing with age, and can significantly impact the quality of life (QOL) of many... (Observational Study)
Observational Study
Pelvic organ prolapse (POP) is a common condition in women, with its prevalence increasing with age, and can significantly impact the quality of life (QOL) of many individuals. The objective of this study was to assess the overall improvement, quality of life, and continuation of primary treatment for POP over a 24-month period in a real-world setting. This is a prospective, observational, follow-up study of women with symptomatic POP who, as a primary treatment, opted for recommendations (lifestyle changes and pelvic floor muscle training), pessary therapy, or surgery. The primary outcome measure was a subjective improvement at the 24-month follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcome measures were the continuation rate of the primary treatment method, reason for discontinuation, and the quality of life evaluated with the P-QoL questionnaire. We included 137 women, with 45 women (32.8%) in the recommendations group, 39 (28.5%) in the pessary group, and 53 women (38.7%) in the surgery group. After 24 months, surgery, in comparison with pessary treatment and recommendations, resulted in significantly more women reporting a subjective improvement: 89.6%, 66.7%, and 22.9% ( < 0.001), respectively. Overall, 52% of women from the recommendations group and 36.4% from the pessary group switched to another treatment or discontinued the primary treatment within 24 months. However, women who continued the primary treatment, pessary use, and surgery showed similar subjective improvements (90.5% and 89.6%, respectively) and quality-of-life improvement. The chance of significant improvement was higher following surgery. However, after 24 months, both vaginal pessaries and surgery showed an important quality-of life improvement and can be proposed as primary treatment methods for pelvic organ prolapse.
Topics: Humans; Quality of Life; Female; Pelvic Organ Prolapse; Pessaries; Prospective Studies; Middle Aged; Aged; Follow-Up Studies; Surveys and Questionnaires; Treatment Outcome
PubMed: 38674193
DOI: 10.3390/medicina60040547 -
BMJ (Clinical Research Ed.) Apr 2024The studyHagen S, Kearney R, Goodman K, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a...
The studyHagen S, Kearney R, Goodman K, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. 2023;66:102326.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/pelvic-organ-prolapse-self-management-of-pessaries-can-be-a-good-option/.
Topics: Humans; Pelvic Organ Prolapse; Pessaries; Female; Self-Management
PubMed: 38663924
DOI: 10.1136/bmj.q866 -
Animal Reproduction Science Jun 2024The success of fixed - time artificial insemination (AI) in the ewe is variable due to poor synchrony of estrus. We examined the effects of long-term nutrition (LTN;...
The success of fixed - time artificial insemination (AI) in the ewe is variable due to poor synchrony of estrus. We examined the effects of long-term nutrition (LTN; low, medium, high - 6 months), short-term nutrition (STN; 1.0 M, 1.5 M - 14 days) and progesterone supplementation (P; single pessary, replacement on Day 9) on synchrony and reproductive outcomes. High LTN advanced (P < 0.05) estrus, increased (P = 0.06) pregnancy (range 71.1 - 81.1%) and improved (P < 0.01) litter size (range 1.30 - 1.50). STN increased (P < 0.05) pregnancy (79.0 versus 72.3%) but not litter size or timing of estrus. A LTN x STN interaction (P < 0.01) for time of estrus indicates that the effects of LTN were moderated by STN depending on the level of LTN. Pessary replacement delayed (P < 0.05) the onset of estrus, improved synchrony but did not affect pregnancy or litter size. High LTN increased (P < 0.05) the number of large (≥ 3.8 mm) and medium - size follicles (2.0 - 3.7 mm) but the diameter of large follicles tended to be reduced (P = 0.08) on Day 12. STN did not affect follicle number or size whilst P reduced (P < 0.05) the diameter of large follicles on Day 12 (4.83 versus 5.10 mm) and increased the number of medium - size follicles (3.56 versus 2.74 mm). In conclusion, both LTN and STN are major sources of variability in AI programs whilst pessary replacement has potential to reduce variability.
Topics: Animals; Female; Progesterone; Insemination, Artificial; Pregnancy; Sheep; Dietary Supplements; Estrus Synchronization; Animal Nutritional Physiological Phenomena; Animal Feed; Litter Size; Diet; Estrus; Time Factors
PubMed: 38663150
DOI: 10.1016/j.anireprosci.2024.107477 -
Urogynecology (Philadelphia, Pa.) Apr 2024Federally Qualified Health Centers (FQHCs) play an important role in providing care to underserved populations. However, little is known about the availability of...
IMPORTANCE
Federally Qualified Health Centers (FQHCs) play an important role in providing care to underserved populations. However, little is known about the availability of urogynecology services at FQHCs.
OBJECTIVES
This study aimed to assess the availability of appointments for urogynecology care and to determine the prevalence of FQHCs offering urogynecologic services.
STUDY DESIGN
A total of 362 FQHCs across the United States were randomly selected from the Health Resources and Services Administration website, based on specific inclusion criteria. Researchers called the FQHCs and requested the earliest available appointment for pelvic organ prolapse. The availability of urogynecologic services such as pessary fittings, pelvic floor physical therapy, and urodynamic studies was also inquired.
RESULTS
A total of 362 FQHCs located in 46 states and the District of Columbia were called. On average, the 362 FQHCs had been established for 19.9 (SD ±15) years, were located in urban areas, and served a median county population of 24,573. Of the 220 FQHCs successfully contacted, 81% (180/220) reported that they could provide care for a patient with pelvic organ prolapse at an appointment 29.1 business days (SD ±30 days) from the date of the call, on average. However, only a small percentage of these FQHCs offered in-office pessary fittings (11%), complex multichannel urodynamics testing (8.6%), or pelvic floor physical therapy (5%).
CONCLUSION
The availability of treatments for pelvic floor disorders at FQHCs is limited. These findings highlight a potential disparity in access to urogynecology services for individuals with public insurance.
PubMed: 38659101
DOI: 10.1097/SPV.0000000000001514 -
AJOG Global Reports May 2024The incidence of preterm delivery is much higher in twin pregnancies than in singletons and even higher if a short cervical length is detected in the second trimester.... (Review)
Review
The effect of cervical pessary on increasing gestational age at delivery in twin pregnancies with asymptomatic short cervix: a systematic review and meta-analysis of randomized controlled trials.
OBJECTIVE
The incidence of preterm delivery is much higher in twin pregnancies than in singletons and even higher if a short cervical length is detected in the second trimester. Studies are contradictory regarding the efficacy of a cervical pessary to decrease preterm birth in twin pregnancies and short cervical length. To conduct a systematic review and meta-analysis investigating the efficacy of cervical pessary in prolonging gestation, preventing preterm birth, and reducing adverse neonatal outcomes in twin pregnancies with an asymptomatic short cervix.
DATA SOURCES
PubMed, Scopus, Web of Science, and ClinicalTrials.org were searched for randomized controlled trials from inception to June 2023.
STUDY ELIGIBILITY CRITERIA
In this study, randomized controlled trials comparing the cervical pessary to expectant management in the pregnant population with twin gestations and asymptomatic short cervix were included.
METHODS
The Cochrane risk-of-bias-2 tool for randomized controlled trials was used for the evaluation of the risk of bias in included studies. A meta-analysis was performed by calculating risk ratio and mean difference with their 95% confidence interval using the random effects model or fixed effect model on the basis of heterogeneity and accounting for potential covariates among the included randomized controlled trials.
RESULTS
A total of 6 randomized controlled trials were included in the analysis. Cervical pessary did not significantly increase the gestational age at delivery in twin pregnancies with asymptomatic patients (mean difference, 0.36 weeks [-0.27 to 0.99]; =.270; I=72.0%). Moreover, the cervical pessary use did not result in a reduction of spontaneous or all-preterm birth before 37 weeks of gestation (risk ratio, 0.88 [0.77-1.00]; =.061; I=0.0%). There was no statistically significant difference in the composite neonatal adverse outcomes (risk ratio, 1.001 [0.86-1.16]; =.981; I=20.9%), including early respiratory morbidity, intraventricular hemorrhage, necrotizing enterocolitis, and confirmed sepsis.
CONCLUSION
The use of cervical pessary in twin pregnancies with asymptomatic short cervix does not seem to be effective in increasing the gestational age at delivery, preventing preterm birth, or reducing adverse neonatal outcomes. This indicates that alternative interventions should be sought for the management of this patient population.
PubMed: 38655568
DOI: 10.1016/j.xagr.2024.100347