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Journal of Perinatal Medicine Jun 2024We aimed to perform a systematic review and network meta-analysis to evaluate the preventive strategies for preterm birth in twin-to-twin transfusion syndrome.
OBJECTIVES
We aimed to perform a systematic review and network meta-analysis to evaluate the preventive strategies for preterm birth in twin-to-twin transfusion syndrome.
METHODS
PubMed, Embase and Cochrane Central were searched from inception to December 2023 with no filters. Additionally, the reference lists of the included studies were manually examined to identify any supplementary studies. We selected randomized controlled trials and cohorts comparing interventions to prevent preterm birth in twin pregnancies complicated by twin-to-twin transfusion syndrome. A random-effects frequentist network meta-analysis was performed using RStudio version 4.3.1. Randomized controlled trials and cohorts were assessed respectively using the Risk of Bias in Non-randomized Studies of interventions tool and Cochrane Collaboration's tool for assessing risk of bias in randomized trials.
RESULTS
In this systematic review and meta-analysis, we included eight studies comprising a total of 719 patients. Compared with expectant management, cerclage stood out as the only intervention associated with an increase in the survival of at least one twin (risk ratio 1.12; 95 % confidence interval 1.01-1.23). Our subgroup analysis based on different thresholds for short cervix demonstrated a significant reduction in the risk of preterm birth before 32 weeks with ultrasound-indicated cerclage using a 15 mm criterion (risk ratio 0.65; 95 % confidence interval 0.47-0.92).
CONCLUSIONS
Our study suggests the potential benefit of cerclage as a preventive strategy for preterm birth in pregnancies complicated by twin-to-twin transfusion syndrome. These findings highlight the necessity for further investigation to corroborate our results and address the optimal threshold for ultrasound-indicated cerclage.
PubMed: 38905455
DOI: 10.1515/jpm-2024-0119 -
International Journal of Gynaecology... May 2024Recent recommendations from the French High Authority of Health on pelvic organ prolapse (POP) management underline the value of a pelvic examination. (Review)
Review
BACKGROUND
Recent recommendations from the French High Authority of Health on pelvic organ prolapse (POP) management underline the value of a pelvic examination.
OBJECTIVES
The aim of this paper was to analyze the literature and identify the best evidence available regarding pelvic examination for women presenting prolapse-associated symptoms in terms of diagnosis and predictability of treatment success.
SEARCH STRATEGY
The databases were queried similarly using Medical Subject Headings (MeSH) and non-MeSH terms broadly related to pelvic examination and POP management.
SELECTION CRITERIA
We included studies assessing the diagnostic contribution of pelvic examination (correlation with symptoms) and its value for assessing the risk of pessary failure or recurrence after reconstructive surgery.
DATA COLLECTION AND ANALYSIS
We assessed peer-reviewed articles on PubMed, Embase, and Cochrane database up to May 2023. The methodological quality of all the included studies was assessed using the ROBINS-E or RoB2 tools.
MAIN RESULTS
In all, 67 studies were retained for the review. Prolapse-associated symptoms are poorly correlated with POP diagnosis. The symptom that is best correlated with the POP stage is the presence of a vaginal bulge (moderate to good correlation). The factors most strongly associated with the risk of recurrence after surgery or pessary failure are clinical: essentially a higher POP stage before surgery, levator ani muscle avulsion, and vaginal and genital measurements.
CONCLUSIONS
In women complaining of prolapse-associated symptoms, a pelvic examination (vaginal speculum and digital vaginal examination) can confirm the presence of POP and identify risk factors for treatment failure or recurrence after surgical management or pessary placement. A higher stage of POP and levator ani muscle avulsion-discernible on pelvic examination-are major risk factors for POP recurrence or treatment failure. These features must be taken into account in the treatment choice and discussed with the patient.
PubMed: 38778697
DOI: 10.1002/ijgo.15697 -
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 -
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 -
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 -
International Journal of Gynaecology... May 2024Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. (Review)
Review
Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta-analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation.
BACKGROUND
Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent.
OBJECTIVES
Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure.
SEARCH STRATEGY AND SELECTION CRITERIA
Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries.
DATA COLLECTION AND ANALYSIS
We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices.
MAIN RESULTS
Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre-registration, but mainly non-adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12-0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13-0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10-0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35-0.82) after a pessary as compared with controls.
CONCLUSION
Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Pessaries; Medical Device Legislation; Randomized Controlled Trials as Topic; Cervix Uteri; Pregnancy, Twin
PubMed: 37830250
DOI: 10.1002/ijgo.15169 -
Safety of misoprostol vs dinoprostone for induction of labor: A systematic review and meta-analysis.European Journal of Obstetrics,... Oct 2023Pharmacological agents such as prostaglandins (dinoprostone and misoprostol) are commonly used to reduce the duration of labor and promote vaginal delivery. However, key... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Pharmacological agents such as prostaglandins (dinoprostone and misoprostol) are commonly used to reduce the duration of labor and promote vaginal delivery. However, key safety considerations with its use include an increased risk of uterine rupture, tachysystole and hyperstimulation of pregnant women, which could potentially lead to a non-reassuring fetal heart rate and to fetal hypoxemia. The aim of this systematic review was to assess maternal and fetal outcomes between misoprostol group (PGE1) and dinoprostone group (PGE2) STUDY DESIGN: We search on MEDLINE (PubMed), CINHAL (EBSCOhost), EMBASE, Scopus (Ovid), CENTRAL (January 1, 1998, to December 31, 2022). Patients were eligible if they presented at greater than 36 weeks gestation with an indication for induction of labor and a single live cephalic fetus. We conducted a meta-analysis of data for both primary (cesarean section rate, instrumental deliveries rate, tachysystole, uterine rupture, post-partum haemorrage; chorionamiositis) and secondary outcomes (Apgar at 5 min <7, meconium-stained liquor, NICU admission, infant death) using odds-ratio (OR) as a measure of effect-size. Risk of bias assessment was performed with RoB-I. We performed statistical analyses using Cochrane RevMan version 5.4 software.
RESULTS
We found 39 RCTs comparing the outcomes of interest between misoprostol and dinoprostone. The pooled effect showed no statistically significant difference between the two groups in terms of cesarean section rate [OR: 0.94; 95% CI 0.84-1.05], instrumental deliveries rate [OR: 1.04; 95% CI: 0.90-1.19; p = 0.62], tachysystole [OR: 1.21; 95% CI: 0.91-1.60; p = 0.19], post-partum hemorrhage [OR: 0.85; 95% CI: 0.62-1.15p = 0.30], chorioamnionitis [OR: 0.94; 95% CI: 0.76-1.17p = 0.59], Apgar at 5 min < 7 [OR: 0.83; 95% CI: 0.61-1.12, p = 0.21], meconium-stained liquor [OR: 1.11; 95% CI: 0.97-1.27p = 0.59], NICU admission group [OR: 0.91; 95% CI: 0.77-1.09], infant death [OR: 0.57; 95% CI: 0.22-1.44]. After performing a sub-group analysis based on the type of prostaglandins administrations (oral, vaginal gel, vaginal pessary), results did not change substantially.
CONCLUSIONS
This systematic review and meta-analysis demonstrate that misoprostol and dinoprostone appear to have a similar safety profile.
Topics: Infant; Humans; Female; Pregnancy; Dinoprostone; Misoprostol; Cesarean Section; Uterine Rupture; Prostaglandins; Oxytocics; Abortifacient Agents, Nonsteroidal; Infant Death; Labor, Induced
PubMed: 37660506
DOI: 10.1016/j.ejogrb.2023.08.382 -
Journal of Obstetrics and Gynaecology... Dec 2023Treatment options for cases of pelvic organ prolapse still lead to the use of a pessary rather than a surgical method. Additional therapy is needed to help treat or... (Review)
Review
OBJECTIVES
Treatment options for cases of pelvic organ prolapse still lead to the use of a pessary rather than a surgical method. Additional therapy is needed to help treat or prevent pelvic organ prolapse. Vitamin D deficiency has consistently been associated with decreased muscle function, so it is assumed that it will affect the pelvic floor muscles. This paper systematically explores the differences between 25-hydroxyvitamin D levels in patients with pelvic organ prolapse and non-pelvic organ prolapse.
STUDY DESIGN
A systematic review was conducted through the PubMed, Google Scholar, Cochrane Library, and ScienceDirect databases using relevant keywords. Articles published in the last 10 years-from 2012 to 2022-that were written in English, that discuss the status or effect of vitamin D on pelvic organ prolapse, and that focus on 25 OH-vitamin D were included in the review.
RESULTS
In total, 717 articles were filtered but 8 articles met the criteria. A total of 1339 women with prolapse and without prolapse with ages ranging from 20 years to 78 years were included in the study. The studies found did not use the same standard threshold in determining deficiency status. Most studies have found that there are lower levels of vitamin D in women who have had pelvic organ prolapse. A total of 7 of 8 studies confirmed the comparison of vitamin D-25OH levels in women with pelvic organ prolapse and without pelvic organ prolapse at P < 0.05.
CONCLUSIONS
There are differences between 25-hydroxyvitamin D levels in patients with pelvic organ prolapse and non-pelvic organ prolapse.
Topics: Humans; Female; Pelvic Floor; Pelvic Organ Prolapse; Vitamin D; Calcifediol; Vitamins; Pessaries
PubMed: 37633644
DOI: 10.1016/j.jogc.2023.102198 -
Journal of Personalized Medicine Jun 2023Forty percent of women will experience prolapse in their lifetime. Vaginal pessaries are considered the first line of treatment in selected patients. Major complications... (Review)
Review
BACKGROUND
Forty percent of women will experience prolapse in their lifetime. Vaginal pessaries are considered the first line of treatment in selected patients. Major complications of vaginal pessaries rarely occur.
METHODS
PubMed and Embase were searched from 1961 to 2022 for major complications of vaginal pessaries using Medical Subject Headings (MeSH) and free-text terms. The keywords were pessary or pessaries and: vaginal discharge, incontinence, entrapment, urinary infections, fistula, complications, and vaginal infection. The exclusion criteria were other languages than English, pregnancy, complications without a prior history of pessary placement, pessaries unregistered for clinical practice (herbal pessaries), or male patients. The extracted data included symptoms, findings upon examination, infection, type of complication, extragenital symptoms, and treatment.
RESULTS
We identified 1874 abstracts and full text articles; 54 were assessed for eligibility and 49 met the inclusion criteria. These 49 studies included data from 66 patients with pessary complications amenable to surgical correction. Clavien-Dindo classification was used to grade the complications. Most patients presented with vaginal symptoms such as bleeding, discharge, or ulceration. The most frequent complications were pessary incarceration and fistulas. Surgical treatment included removal of the pessary under local or general anesthesia, fistula repair, hysterectomy and vaginal repair, and the management of bleeding.
CONCLUSIONS
Pessaries are a reasonable and durable treatment for pelvic organ prolapse. Complications are rare. Routine follow-ups are necessary. The ideal patient candidate must be able to remove and reintroduce their pessary on a regular basis; if not, this must be performed by a healthcare worker at regular intervals.
PubMed: 37511669
DOI: 10.3390/jpm13071056