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PLoS Medicine Oct 2020The effectiveness of screening for macrosomia is not well established. One of the critical elements of an effective screening program is the diagnostic accuracy of a... (Meta-Analysis)
Meta-Analysis
Universal third-trimester ultrasonic screening using fetal macrosomia in the prediction of adverse perinatal outcome: A systematic review and meta-analysis of diagnostic test accuracy.
BACKGROUND
The effectiveness of screening for macrosomia is not well established. One of the critical elements of an effective screening program is the diagnostic accuracy of a test at predicting the condition. The objective of this study is to investigate the diagnostic effectiveness of universal ultrasonic fetal biometry in predicting the delivery of a macrosomic infant, shoulder dystocia, and associated neonatal morbidity in low- and mixed-risk populations.
METHODS AND FINDINGS
We conducted a predefined literature search in Medline, Excerpta Medica database (EMBASE), the Cochrane library and ClinicalTrials.gov from inception to May 2020. No language restrictions were applied. We included studies where the ultrasound was performed as part of universal screening and those that included low- and mixed-risk pregnancies and excluded studies confined to high risk pregnancies. We used the estimated fetal weight (EFW) (multiple formulas and thresholds) and the abdominal circumference (AC) to define suspected large for gestational age (LGA). Adverse perinatal outcomes included macrosomia (multiple thresholds), shoulder dystocia, and other markers of neonatal morbidity. The risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Meta-analysis was carried out using the hierarchical summary receiver operating characteristic (ROC) and the bivariate logit-normal (Reitsma) models. We identified 41 studies that met our inclusion criteria involving 112,034 patients in total. These included 11 prospective cohort studies (N = 9986), one randomized controlled trial (RCT) (N = 367), and 29 retrospective cohort studies (N = 101,681). The quality of the studies was variable, and only three studies blinded the ultrasound findings to the clinicians. Both EFW >4,000 g (or 90th centile for the gestational age) and AC >36 cm (or 90th centile) had >50% sensitivity for predicting macrosomia (birthweight above 4,000 g or 90th centile) at birth with positive likelihood ratios (LRs) of 8.74 (95% confidence interval [CI] 6.84-11.17) and 7.56 (95% CI 5.85-9.77), respectively. There was significant heterogeneity at predicting macrosomia, which could reflect the different study designs, the characteristics of the included populations, and differences in the formulas used. An EFW >4,000 g (or 90th centile) had 22% sensitivity at predicting shoulder dystocia with a positive likelihood ratio of 2.12 (95% CI 1.34-3.35). There was insufficient data to analyze other markers of neonatal morbidity.
CONCLUSIONS
In this study, we found that suspected LGA is strongly predictive of the risk of delivering a large infant in low- and mixed-risk populations. However, it is only weakly (albeit statistically significantly) predictive of the risk of shoulder dystocia. There was insufficient data to analyze other markers of neonatal morbidity.
Topics: Birth Weight; Diagnostic Tests, Routine; Female; Fetal Macrosomia; Fetal Weight; Gestational Age; Humans; Mass Screening; Noninvasive Prenatal Testing; Parturition; Pregnancy; Pregnancy Complications; Pregnancy Trimester, Third; Prospective Studies; Retrospective Studies; Ultrasonics; Ultrasonography; Ultrasonography, Prenatal
PubMed: 33048935
DOI: 10.1371/journal.pmed.1003190 -
BMC Pregnancy and Childbirth May 2023Caesarean section (CS) is widely perceived as protective against obstetric brachial plexus injury (BPI), but few studies acknowledge the factors associated with such...
BACKGROUND
Caesarean section (CS) is widely perceived as protective against obstetric brachial plexus injury (BPI), but few studies acknowledge the factors associated with such injury. The objectives of this study were therefore to aggregate cases of BPI after CS, and to illuminate risk factors for BPI.
METHODS
Pubmed Central, EMBASE and MEDLINE databases were searched using free text: ("brachial plexus injury" or "brachial plexus injuries" or "brachial plexus palsy" or "brachial plexus palsies" or "Erb's palsy" or "Erb's palsies" or "brachial plexus birth injury" or "brachial plexus birth palsy") and ("caesarean" or "cesarean" or "Zavanelli" or "cesarian" or "caesarian" or "shoulder dystocia"). Studies with clinical details of BPI after CS were included. Studies were assessed using the National Institutes for Healthy Study Quality Assessment Tool for Case Series, Cohort and Case-Control Studies.
MAIN RESULTS
39 studies were eligible. 299 infants sustained BPI after CS. 53% of cases with BPI after CS had risk factors for likely challenging handling/manipulation of the fetus prior to delivery, in the presence of considerable maternal or fetal concerns, and/or in the presence of poor access due to obesity or adhesions.
CONCLUSIONS
In the presence of factors that would predispose to a challenging delivery, it is difficult to justify that BPI could occur due to in-utero, antepartum events alone. Surgeons should exercise care when operating on women with these risk factors.
Topics: Female; Pregnancy; Humans; Cesarean Section; Brachial Plexus; Brachial Plexus Neuropathies; Case-Control Studies; Risk Factors; Paralysis; Birth Injuries; Dystocia
PubMed: 37198580
DOI: 10.1186/s12884-023-05696-1 -
Acta Obstetricia Et Gynecologica... Jan 2022Little is known about the optimal simulation-based team training in obstetric emergencies. We aimed to review how simulation-based team training affects patient outcomes... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Little is known about the optimal simulation-based team training in obstetric emergencies. We aimed to review how simulation-based team training affects patient outcomes in obstetric emergencies.
MATERIAL AND METHODS
Search Strategy: MEDLINE, Embase, Cochrane Library, and Cochrane Central Register of Controlled Trials were searched up to and including May 15, 2021.
SELECTION CRITERIA
randomized controlled trials (RCTs) and cohort studies on obstetric teams in high-resource settings comparing the effect of simulation-based obstetric emergency team training with no training on the risk of Apgar scores less than 7 at 5 min, neonatal hypoxic ischemic encephalopathy, severe postpartum hemorrhage, blood transfusion of four or more units, and delay of emergency cesarean section by more than 30 min.
DATA COLLECTION AND ANALYSIS
The included studies were assessed using PRISMA, EPCO, and GRADE.
RESULTS
We found 21 studies, four RCTs and 17 cohort studies, evaluating patient outcomes after obstetric team training compared with no training. Annual obstetric emergency team training may reduce brachial plexus injury (six cohort studies: odds ratio [OR] 0.47, 95% CI 0.33-0.68; one RCT: OR 1.30, 95 CI% 0.39-4.33, low certainty evidence) and suggest a positive effect; but it was not significant on Apgar score below 7 at 5 min (three cohort studies: OR 0.77, 95% CI 0.51-1.19; two RCT: OR 0.87, 95% CI 0.72-1.05, moderate certainty evidence). The effect was unclear for hypoxic ischemic encephalopathy, umbilical prolapse, decision to birth interval in emergency cesarean section, and for severe postpartum hemorrhage. Studies with in situ multi-professional simulation-based training demonstrated the best effect.
CONCLUSIONS
Emerging evidence suggests an effect of obstetric team training on obstetric outcomes, but conflicting results call for controlled trials targeted to identify the optimal methodology for effective team training.
Topics: Emergency Service, Hospital; Female; Humans; Infant, Newborn; Outcome Assessment, Health Care; Patient Care Team; Postpartum Hemorrhage; Pregnancy; Prenatal Care; Randomized Controlled Trials as Topic; Simulation Training
PubMed: 34622945
DOI: 10.1111/aogs.14263 -
Nutrients Jan 2020Gestational diabetes (GDM) has deleterious effects on the offspring. Maternal obesity and excessive gestational weight gain (GWG), often associated with diabetes, also... (Meta-Analysis)
Meta-Analysis
UNLABELLED
Gestational diabetes (GDM) has deleterious effects on the offspring. Maternal obesity and excessive gestational weight gain (GWG), often associated with diabetes, also contribute to these adverse outcomes.
OBJECTIVES
To assess the benefit for the offspring of maternal lifestyle interventions, including diets and physical activity, to prevent or to improve GDM and to limit excessive GWG.
METHOD
Systematic review of meta-analyses published in English between December 2014 and November 2019.
RESULTS
Lifestyle interventions to reduce the risk of GDM reported a decreased risk of 15% to 40%, with a greater effect of exercise compared to diet. Combined lifestyle interventions specifically designed to limit GWG reduced GWG by 1.6 kg in overweight and obese women, and on average by 0.7 to 1 kg in all pregnant women. In these trials, adverse neonatal outcomes were poorly studied. Combined lifestyle interventions in women with GDM significantly reduced fetal growth. Altogether, lifestyle interventions reduced the risk of preterm birth and shoulder dystocia, but individually, diets or exercise alone had no effect on neonatal adverse outcomes.
CONCLUSION
Specific maternal, neonatal and offspring benefits of lifestyle interventions during pregnancy to prevent or improve GDM control or to limit GWG still require clarification.
Topics: Adult; Diabetes, Gestational; Female; Humans; Infant, Newborn; Life Style; Pregnancy; Weight Gain
PubMed: 32013197
DOI: 10.3390/nu12020353 -
Frontiers in Endocrinology 2021It is uncertain whether the treatment of mild gestational diabetes mellitus (GDM) improves pregnancy outcomes. The aim of this systemic review and meta-analysis was to... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
It is uncertain whether the treatment of mild gestational diabetes mellitus (GDM) improves pregnancy outcomes. The aim of this systemic review and meta-analysis was to investigate the effect of mild GDM treatment on adverse pregnancy outcomes.
METHODS
A comprehensive literature search was conducted on the databases of PubMed, Scopus, and Google Scholar to retrieve studies that compared interventions for the treatment of mild GDM with usual antenatal care. The fixed/random effects models were used for the analysis of heterogeneous and non-heterogeneous results. Publication bias was assessed using the Harbord test. Also, the DerSimonian and Laird, and inverse variance methods were used to calculate the pooled odds ratio of events. The quality assessment of the included studies was performed using the Modified Newcastle-Ottawa Quality Assessment scale and the CONSORT checklist. In addition, the risk of bias was evaluated using the Cochrane Collaboration's tool for assessing risk of bias.
RESULTS
The systematic review and meta-analysis involved ten studies consisting of 3317 pregnant women who received treatment for mild GDM and 4407 untreated counterparts. Accordingly, the treatment of mild GDM significantly reduced the risk of macrosomia (OR = 0.3; 95%CI = 0.3-0.4), large for gestational age (OR = 0.4; 95%CI = 0.3-0.5), shoulder dystocia (OR = 0.3; 95%CI = 0.2-0.6), caesarean-section (OR = 0.8; 95%CI = 0.7-0.9), preeclampsia (OR = 0.4; 95%CI = 0.3-0.6), elevated cord C-peptide (OR = 0.7; 95%CI = 0.6-0.9), and respiratory distress syndrome (OR = 0.7; 95%CI = 0.5-0.9) compared to untreated counterparts. Moreover, the risk of induced labor significantly increased in the treated group compared to the untreated group (OR = 1.3; 95%CI = 1.0-1.6). However, no statistically significant difference was observed between the groups in terms of small for gestational age, hypoglycemia, hyperbilirubinemia, birth trauma, admission to the neonatal intensive care unit, and preterm birth. Sensitivity analysis based on the exclusion of secondary analysis data was all highly consistent with the main data analysis.
CONCLUSION
Treatment of mild GDM reduced the risk of selected important maternal outcomes including preeclampsia, macrosomia, large for gestational age, cesarean section, and shoulder dystocia without increasing the risk of small for gestational age. Nevertheless, the treatment could not reduce the risk of neonatal metabolic abnormalities or several complications in newborn.
Topics: Diabetes, Gestational; Female; Fetal Macrosomia; Humans; Infant, Newborn; Infant, Newborn, Diseases; Infant, Small for Gestational Age; Male; Metabolic Diseases; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Premature Birth; Risk
PubMed: 33841332
DOI: 10.3389/fendo.2021.640004 -
Health Technology Assessment... Feb 2021Currently, pregnant women are screened using ultrasound to perform gestational aging, typically at around 12 weeks' gestation, and around the middle of pregnancy....
BACKGROUND
Currently, pregnant women are screened using ultrasound to perform gestational aging, typically at around 12 weeks' gestation, and around the middle of pregnancy. Ultrasound scans thereafter are performed for clinical indications only.
OBJECTIVES
We sought to assess the case for offering universal late pregnancy ultrasound to all nulliparous women in the UK. The main questions addressed were the diagnostic effectiveness of universal late pregnancy ultrasound to predict adverse outcomes and the cost-effectiveness of either implementing universal ultrasound or conducting further research in this area.
DESIGN
We performed diagnostic test accuracy reviews of five ultrasonic measurements in late pregnancy. We conducted cost-effectiveness and value-of-information analyses of screening for fetal presentation, screening for small for gestational age fetuses and screening for large for gestational age fetuses. Finally, we conducted a survey and a focus group to determine the willingness of women to participate in a future randomised controlled trial.
DATA SOURCES
We searched MEDLINE, EMBASE and the Cochrane Library from inception to June 2019.
REVIEW METHODS
The protocol for the review was designed a priori and registered. Eligible studies were identified using keywords, with no restrictions for language or location. The risk of bias in studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Health economic modelling employed a decision tree analysed via Monte Carlo simulation. Health outcomes were from the fetal perspective and presented as quality-adjusted life-years. Costs were from the perspective of the public sector, defined as NHS England, and the costs of special educational needs. All costs and quality-adjusted life-years were discounted by 3.5% per annum and the reference case time horizon was 20 years.
RESULTS
Umbilical artery Doppler flow velocimetry, cerebroplacental ratio, severe oligohydramnios and borderline oligohydramnios were all either non-predictive or weakly predictive of the risk of neonatal morbidity (summary positive likelihood ratios between 1 and 2) and were all weakly predictive of the risk of delivering a small for gestational age infant (summary positive likelihood ratios between 2 and 4). Suspicion of fetal macrosomia is strongly predictive of the risk of delivering a large infant, but it is only weakly, albeit statistically significantly, predictive of the risk of shoulder dystocia. Very few studies blinded the result of the ultrasound scan and most studies were rated as being at a high risk of bias as a result of treatment paradox, ascertainment bias or iatrogenic harm. Health economic analysis indicated that universal ultrasound for fetal presentation only may be both clinically and economically justified on the basis of existing evidence. Universal ultrasound including fetal biometry was of borderline cost-effectiveness and was sensitive to assumptions. Value-of-information analysis indicated that the parameter that had the largest impact on decision uncertainty was the net difference in cost between an induced delivery and expectant management.
LIMITATIONS
The primary literature on the diagnostic effectiveness of ultrasound in late pregnancy is weak. Value-of-information analysis may have underestimated the uncertainty in the literature as it was focused on the internal validity of parameters, which is quantified, whereas the greatest uncertainty may be in the external validity to the research question, which is unquantified.
CONCLUSIONS
Universal screening for presentation at term may be justified on the basis of current knowledge. The current literature does not support universal ultrasonic screening for fetal growth disorders.
FUTURE WORK
We describe proof-of-principle randomised controlled trials that could better inform the case for screening using ultrasound in late pregnancy.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42017064093.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 15. See the NIHR Journals Library website for further project information.
Topics: Cost-Benefit Analysis; Female; Gestational Age; Humans; Infant, Newborn; Mass Screening; Parity; Pregnancy; Randomized Controlled Trials as Topic; Ultrasonography
PubMed: 33656977
DOI: 10.3310/hta25150 -
International Journal of Environmental... Apr 2020Gestational diabetes (GDM) increases the risk of pregnancy complications. However, these risks are not the same for all affected women and may be mediated by...
Gestational diabetes (GDM) increases the risk of pregnancy complications. However, these risks are not the same for all affected women and may be mediated by inter-related factors including ethnicity, body mass index and gestational weight gain. This study was conducted to identify, compare, and critically appraise prognostic prediction models for pregnancy complications in women with gestational diabetes (GDM). A systematic review of prognostic prediction models for pregnancy complications in women with GDM was conducted. Critical appraisal was conducted using the prediction model risk of bias assessment tool (PROBAST). Five prediction modelling studies were identified, from which ten prognostic models primarily intended to predict pregnancy complications related to GDM were developed. While the composition of the pregnancy complications predicted varied, the delivery of a large-for-gestational age neonate was the subject of prediction in four studies, either alone or as a component of a composite outcome. Glycaemic measures and body mass index were selected as predictors in four studies. Model evaluation was limited to internal validation in four studies and not reported in the fifth. Performance was inadequately reported with no useful measures of calibration nor formal evaluation of clinical usefulness. Critical appraisal using PROBAST revealed that all studies were subject to a high risk of bias overall driven by methodologic limitations in statistical analysis. This review demonstrates the potential for prediction models to provide an individualised absolute risk of pregnancy complications for women affected by GDM. However, at present, a lack of external validation and high risk of bias limit clinical application. Future model development and validation should utilise the latest methodological advances in prediction modelling to achieve the evolution required to create a useful clinical tool. Such a tool may enhance clinical decision-making and support a risk-stratified approach to the management of GDM. Systematic review registration: PROSPERO CRD42019115223.
Topics: Blood Glucose; Body Mass Index; Diabetes, Gestational; Female; Forecasting; Gestational Age; Humans; Infant; Models, Theoretical; Pregnancy; Pregnancy Complications; Pregnancy Outcome
PubMed: 32349442
DOI: 10.3390/ijerph17093048 -
BJOG : An International Journal of... Oct 2021To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with...
OBJECTIVE
To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM).
DESIGN
A consensus developmental study.
SETTING
International.
POPULATION
Two hundred and five stakeholders completed the first round.
METHODS
The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS.
MAIN OUTCOME MEASURES
All outcomes were extracted from the literature.
RESULTS
We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death.
CONCLUSIONS
This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM.
TWEETABLE ABSTRACT
165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.
Topics: Consensus; Delphi Technique; Diabetes, Gestational; Female; Humans; International Cooperation; Outcome Assessment, Health Care; Pregnancy; Prenatal Care; Randomized Controlled Trials as Topic; Stakeholder Participation; Treatment Outcome
PubMed: 34218508
DOI: 10.1111/1471-0528.16825 -
BJOG : An International Journal of... Dec 2019There are questions about the use of the 'one-centimetre per hour rule' as a valid benchmark for assessing the adequacy of labour progress.
BACKGROUND
There are questions about the use of the 'one-centimetre per hour rule' as a valid benchmark for assessing the adequacy of labour progress.
OBJECTIVES
To determine the accuracy of the alert (1-cm/hour) and action lines of the cervicograph in the partograph to predict adverse birth outcomes among women in first stage of labour.
SEARCH STRATEGY
PubMed, EMBASE, CINAHL, POPLINE, Global Health Library, and reference lists of eligible studies.
SELECTION CRITERIA
Observational studies and other study designs reporting data on the correlation between the alert line status of women in labour and the occurrence of adverse birth outcomes.
DATA COLLECTION AND ANALYSIS
Two reviewers at a time independently identified eligible studies and independently abstracted data including population characteristics and maternal and perinatal outcomes.
MAIN RESULTS
Thirteen studies in which 20 471 women participated were included in the review. The percentage of women crossing the alert line varied from 8 to 76% for all maternal or perinatal outcomes. No study showed a robust diagnostic test accuracy profile for any of the selected outcomes.
CONCLUSIONS
This systematic review does not support the use of the cervical dilatation over time (at a threshold of 1 cm/h during active first stage) to identify women at risk of adverse birth outcomes.
TWEETABLE ABSTRACT
Alert line of partograph does not identify women at risk of adverse birth outcomes.
Topics: Adult; Cesarean Section; Delivery, Obstetric; Female; Humans; Infant, Newborn; Labor, Obstetric; Predictive Value of Tests; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Reproducibility of Results; Term Birth; Uterine Inertia; Uterine Monitoring
PubMed: 31334912
DOI: 10.1111/1471-0528.15884