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Obstetrics and Gynecology Feb 2021To identify and quantify risk factors for atonic postpartum hemorrhage. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To identify and quantify risk factors for atonic postpartum hemorrhage.
DATA SOURCES
PubMed, CINAHL, EMBASE, Web of Science, and and ClinicalTrials.gov databases were searched for English language studies with no restrictions on date or location. Studies included randomized trials, prospective or retrospective cohort studies, and case-control studies of pregnant patients who developed atonic postpartum hemorrhage and reported at least one risk factor.
METHODS OF STUDY SELECTION
Title, abstract, and full-text screening were performed using the Raayan web application. Of 1,239 records screened, 27 studies were included in this review. Adjusted or unadjusted odds ratios (ORs), relative risks, or rate ratios were recorded or calculated. For each risk factor, a qualitative synthesis of low and moderate risk of bias studies classifies the risk factor as definite, likely, unclear, or not a risk factor. For risk factors with sufficiently homogeneous definitions and reference ranges, a quantitative meta-analysis of low and moderate risk of bias studies was implemented to estimate a combined OR.
TABULATION, INTEGRATION, AND RESULTS
Forty-seven potential risk factors for atonic postpartum hemorrhage were identified in this review, of which 15 were judged definite or likely risk factors. The remaining 32 assessed risk factors showed no association with atonic postpartum hemorrhage or had conflicting or unclear evidence.
CONCLUSION
A substantial proportion of postpartum hemorrhage occurs in the absence of recognized risk factors. Many risk factors for atonic hemorrhage included in current risk-assessment tools were confirmed, with the greatest risk conferred by prior postpartum hemorrhage of any etiology, placenta previa, placental abruption, uterine rupture, and multiple gestation. Novel risk factors not currently included in risk-assessment tools included hypertension, diabetes, and ethnicity. Obesity and magnesium were not associated with atonic postpartum hemorrhage in this review.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42020157521.
Topics: Female; Humans; Postpartum Hemorrhage; Pregnancy; Risk Factors; Uterine Inertia
PubMed: 33417319
DOI: 10.1097/AOG.0000000000004228 -
The Cochrane Database of Systematic... Dec 2020Simulation-based obstetric team training focuses on building a system that will anticipate errors, improve patient outcomes and the performance of clinical care teams.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Simulation-based obstetric team training focuses on building a system that will anticipate errors, improve patient outcomes and the performance of clinical care teams. Simulation-based obstetric team training has been proposed as a tool to improve the overall outcome of obstetric health care.
OBJECTIVES
To assess the effects of simulation-based obstetric team training on patient outcomes, performance of obstetric care teams in practice and educational settings, and trainees' experience.
SEARCH METHODS
The Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) were searched (14 April 2020), together with references checking and hand searching the available proceedings of 2 international conferences.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) (including cluster-randomised trials) comparing simulation-based obstetric team training with no, or other type of training.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane, to identify articles, assess methodological quality and extract data. Data from three cluster-randomised trials could be used to perform generic inverse variance meta-analyses. The meta-analyses were based on risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). We used the GRADE approach to rate the certainty of the evidence. We used Kirkpatrick's model of training evaluation to categorise the outcomes of interest; we chose Level 3 (behavioural change) and Level 4 (patient outcome) to categorise the primary outcomes.
MAIN RESULTS
We included eight RCTs, six of which were cluster-randomised trials, involving more than 1000 training participants and more than 200,000 pregnancies/births. Four studies reported on outcome measures on Kirkpatrick level 4 (patient outcome), three studies on Kirkpatrick level 3 (performance in practice), two studies on Kitkpatrick level 2 (performance in educational settings), and none on Kirkpatrick level 1 (trainees' experience). The included studies were from Mexico, the Netherlands, the UK and the USA, all middle- and high-income countries. Kirkpatrick level 4 (patient outcome) Simulation-based obstetric team training may make little or no difference for composite outcomes of maternal and/or perinatal adverse events compared with no training (3 studies; n = 28,731, low-certainty evidence, data not pooled due to different composite outcome definitions). We are uncertain whether simulation-based obstetric team training affects maternal mortality compared with no training (2 studies; 79,246 women; very low-certainty evidence). However, it may reduce neonatal mortality (RR 0.70, 95% CI 0.48 to 1.01; 2 studies, 79,246 pregnancies/births, low-certainty evidence). Simulation-based obstetric team training may have little to no effect on low Apgar score compared with no training (RR 0.99, 95% 0.85 to 1.15; 2 studies; 115,171 infants; low-certainty evidence), but it probably reduces trauma after shoulder dystocia (RR 0.50, 95% CI 0.25 to 0.99; 1 study; moderate-certainty evidence) and probably slightly reduces the number of caesarean deliveries (RR 0.79, 95% CI 0.67 to 0.93; 1 study; n = 50,589; moderate-certainty evidence) Kirkpatrick level 3 (performance in practice) We found that simulation-based obstetric team training probably improves the performance of the obstetric teams in practice, compared with no training (3 studies; 2398 obstetric staff members, moderate-certainty evidence, data not pooled due to different outcome definitions).
AUTHORS' CONCLUSIONS
Simulation-based obstetric team training may help to improve team performance of obstetric teams, and it might contribute to improvement of specific maternal and perinatal outcomes, compared with no training. However, high-certainty evidence is lacking due to serious risk of bias and imprecision, and the effect cannot be generalised for all outcomes. Future studies investigating simulation-based obstetric team training compared to training courses with a different instructional design should carefully consider how and when to measure outcomes. Particular attention should be paid to effect measurement at the level of patient outcome, taking into consideration the low incidence of adverse maternal and perinatal events.
Topics: Apgar Score; Bias; Cesarean Section; Clinical Competence; Confidence Intervals; Emergencies; Female; Humans; Infant; Infant Mortality; Infant, Newborn; Maternal Mortality; Medical Errors; Obstetrics; Patient Care Team; Pregnancy; Randomized Controlled Trials as Topic; Shoulder Dystocia; Simulation Training; Treatment Outcome
PubMed: 33325570
DOI: 10.1002/14651858.CD011545.pub2 -
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 -
PloS One 2020Pre-gestational diabetes mellitus is associated with increased risk of maternal and perinatal adverse outcomes. This systematic review was conducted to evaluate the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pre-gestational diabetes mellitus is associated with increased risk of maternal and perinatal adverse outcomes. This systematic review was conducted to evaluate the effectiveness and safety of pre-conception care (PCC) in improving maternal and perinatal outcomes.
METHODS
Databases from MEDLINE, EMBASE, WEB OF SCIENCE, and Cochrane Library were searched, including the CENTRAL register of controlled trials, and CINHAL up until March 2019, without any language restrictions, for any pre-pregnancy care aiming at health promotion, glycemic control, and screening and treatment of diabetes complications in women with type I or type II pre-gestational diabetes. Trials and observational studies were included in the review. Newcastle-Ottawa scale and the Cochrane collaboration methodology for data synthesis and analysis were used, along with the GRADE tool to evaluate the body of evidence.
RESULTS
The search identified 8500 potentially relevant citations of which 40 reports of 36 studies were included. The meta-analysis results show that PCC reduced congenital malformations risk by 71%, (Risk ratio (RR) 0.29; 95% CI: 0.21-0.40, 25 studies; 5903 women; high-certainty evidence). The results also show that PCC may lower HbA1c in the first trimester of pregnancy by an average of 1.27% (Mean difference (MD) 1.27; 95% CI: 1.33-1.22; 4927 women; 24 studies, moderate-certainty evidence). Furthermore, the results suggest that PCC may lead to a slight reduction in the risk of preterm delivery of 15%, (RR 0.85; 95% CI: 0.73-0.99; nine studies, 2414 women; moderate-certainty evidence). Moreover, PCC may result in risk reduction of perinatal mortality by 54%, (RR 0.46; 95% CI: 0.30-0.73; ten studies; 3071 women; moderate-certainty evidence). There is uncertainty about the effects of PCC on the early booking for antenatal care (MD 1.31; 95% CI: 1.40-1.23; five studies, 1081 women; very low-certainty evidence) and maternal hypoglycemia in the first trimester, (RR 1.38; 95% CI: 1.07-1.79; three studies; 686 women; very low- certainty evidence). In addition, results of the meta-analysis indicate that PCC may lead to 48% reduction in the risk of small for gestational age (SGA) (RR 0.52; 95% CI: 0.37-0.75; six studies, 2261 women; moderate-certainty evidence). PCC may reduce the risk of neonatal admission to intensive care unit (NICU) by 25% (RR 0.75; 95% CI: 0.67-0.84; four studies; 1322 women; moderate-certainty evidence). However, PCC may have little or no effect in reducing the cesarean section rate (RR 1.02; 95% CI: 0.96-1.07; 14 studies; 3641 women; low-certainty evidence); miscarriage rate (RR 0.86; 95% CI: 0.70-1.06; 11 studies; 2698 women; low-certainty evidence); macrosomia rate (RR 1.06; 95% CI: 0.97-1.15; nine studies; 2787 women, low-certainty evidence); neonatal hypoglycemia (RR 0.93; 95% CI: 0.74-1.18; five studies; 880 women; low-certainty evidence); respiratory distress syndrome (RR 0.78; 95% CI: 0.47-1.29; four studies; 466 women; very low-certainty evidence); or shoulder dystocia (RR 0.28; 95% CI: 0.07-1.12; 2 studies; 530 women; very low-certainty evidence).
CONCLUSION
PCC for women with pre-gestational type 1 or type 2 diabetes mellitus is effective in improving rates of congenital malformations. In addition, it may improve the risk of preterm delivery and admission to NICU. PCC probably reduces maternal HbA1C in the first trimester of pregnancy, perinatal mortality and SGA. There is uncertainty regarding the effects of PCC on early booking for antenatal care or maternal hypoglycemia during the first trimester of pregnancy. PCC has little or no effect on other maternal and perinatal outcomes.
Topics: Female; Health Promotion; Humans; Infant, Newborn; Preconception Care; Pregnancy; Pregnancy Outcome; Pregnancy in Diabetics; Prognosis; Program Evaluation; Treatment Outcome
PubMed: 32810195
DOI: 10.1371/journal.pone.0237571 -
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 -
Revista Brasileira de Ortopedia Apr 2020Obstetric palsy is classically defined as the brachial plexus injury due to shoulder dystocia or to maneuvers performed on difficult childbirths. In the last 2 decades,...
Obstetric palsy is classically defined as the brachial plexus injury due to shoulder dystocia or to maneuvers performed on difficult childbirths. In the last 2 decades, several studies have shown that half of the cases of Obstetric palsy are not associated with shoulder dystocia and have raised other possible etiologies for Obstetric palsy. The purpose of the present study is to collect data from literature reviews, classic articles, sentries, and evidence-based medicine to better understand the events involved in the occurrence of Obstetric palsy. A literature review was conducted in the search engine PubMed (MeSH - Medical Subject Headings) with the following keywords: and , completely open, boundless regarding language or date. Later, the inclusion criterion was defined as revisions. A total of 21 review articles associated with the themes described were found until March 8, 2018. Faced with the best available evidence to date, it is well-demonstrated that Obstetric palsy occurs in uncomplicated deliveries and in cesarean deliveries, and there are multiple factors that can cause it, relativizing the responsibility of obstetricians, nurses, and midwives. The present study aims to break the paradigms that associate Obstetric palsy compulsorily with shoulder dystocia, and that its occurrence necessarily implies negligence, malpractice or recklessness of the team involved.
PubMed: 32346188
DOI: 10.1055/s-0039-1698800 -
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 -
Developmental Medicine and Child... Jun 2020To provide a comprehensive update on the most prevalent, significant risk factors for neonatal brachial plexus palsy (NBPP). (Meta-Analysis)
Meta-Analysis
AIM
To provide a comprehensive update on the most prevalent, significant risk factors for neonatal brachial plexus palsy (NBPP).
METHOD
Cochrane CENTRAL, MEDLINE, Web of Science, Embase, and ClinicalTrials.gov were searched for relevant publications up to March 2019. Studies assessing risk factors of NBPP in relation to typically developing comparison individuals were included. Meta-analysis was performed for the five most significant risk factors, on the basis of the PRISMA statement and MOOSE guidelines. Pooled odds ratios (ORs), 95% confidence intervals (CIs), and across-study heterogeneity (I ) were reported. Reporting bias and quality of evidence was rated. In addition, we assessed the incidence of NBPP.
RESULTS
Twenty-two observational studies with a total sample size of 29 419 037 live births were selected. Significant risk factors included shoulder dystocia (OR 115.27; 95% CI 81.35-163.35; I =92%), macrosomia (OR 9.75; 95% CI 8.29-11.46; I =70%), (gestational) diabetes (OR 5.33; 95% CI 3.77-7.55; I =59%), instrumental delivery (OR 3.8; 95% CI 2.77-5.23; I =77%), and breech delivery (OR 2.49; 95% CI 1.67-3.7; I =70%). Caesarean section appeared as a protective factor (OR 0.13; 95% CI 0.11-0.16; I =41%). The pooled overall incidence of NBPP was 1.74 per 1000 live births. It has decreased in recent years.
INTERPRETATION
The incidence of NBPP is decreasing. Shoulder dystocia, macrosomia, maternal diabetes, instrumental delivery, and breech delivery are risk factors for NBPP. Caesarean section appears as a protective factor.
WHAT THIS PAPER ADDS
The overall incidence of neonatal brachial plexus palsy is 1.74 per 1000 live births. The incidence has declined significantly. Shoulder dystocia, macrosomia, maternal diabetes, instrumental delivery, and breech delivery are the main risk factors. Prevention is difficult owing to unpredictability and often labour-related risk.
Topics: Humans; Incidence; Neonatal Brachial Plexus Palsy; Odds Ratio; Risk Factors
PubMed: 31670385
DOI: 10.1111/dmcn.14381 -
BMC Pregnancy and Childbirth Oct 2019Evidence for the relationship between maternal and perinatal factors and the success of vaginal birth after cesarean section (VBAC) is conflicting. We aimed to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Evidence for the relationship between maternal and perinatal factors and the success of vaginal birth after cesarean section (VBAC) is conflicting. We aimed to systematically analyze published data on maternal and fetal factors for successful VBAC.
METHODS
A comprehensive search of Medline, Embase, and the Cumulative Index to Nursing and Allied Health Literature, from each database's inception to March 16, 2018. Observational studies, identifying women with a trial of labor after one previous low-transverse cesarean section were included. Two reviewers independently abstracted the data. Meta-analysis was performed using the random-effects model. Risk of bias was assessed by the Newcastle-Ottawa Scale.
RESULTS
We included 94 eligible observational studies (239,006 pregnant women with 163,502 VBAC). Factors were associated with successful VBAC with the following odds ratios (OR;95%CI): age (0.92;0.86-0.98), obesity (0.50;0.39-0.64), diabetes (0.50;0.42-0.60), hypertensive disorders complicating pregnancy (HDCP) (0.54;0.44-0.67), Bishop score (3.77;2.17-6.53), labor induction (0.58;0.50-0.67), macrosomia (0.56;0.50-0.64), white race (1.39;1.26-1.54), previous vaginal birth before cesarean section (3.14;2.62-3.77), previous VBAC (4.71;4.33-5.12), the indications for the previous cesarean section (cephalopelvic disproportion (0.54;0.36-0.80), dystocia or failure to progress (0.54;0.41-0.70), failed induction (0.56;0.37-0.85), and fetal malpresentation (1.66;1.38-2.01)). Adjusted ORs were similar.
CONCLUSIONS
Diabetes, HDCP, Bishop score, labor induction, macrosomia, age, obesity, previous vaginal birth, and the indications for the previous CS should be considered as the factors affecting the success of VBAC.
Topics: Birth Weight; Body Mass Index; Female; Gestational Age; Humans; Infant, Newborn; Maternal Age; Pregnancy; Pregnancy Outcome; Prenatal Care; Vaginal Birth after Cesarean
PubMed: 31623587
DOI: 10.1186/s12884-019-2517-y -
The Cochrane Database of Systematic... Sep 2019Gestational diabetes mellitus (GDM) is a common medical condition that complicates pregnancy and causes adverse maternal and fetal outcomes. At present, most treatment...
BACKGROUND
Gestational diabetes mellitus (GDM) is a common medical condition that complicates pregnancy and causes adverse maternal and fetal outcomes. At present, most treatment strategies focus on normalisation of maternal blood glucose values with use of diet, lifestyle modification, exercise, oral anti-hyperglycaemics and insulin. This has been shown to reduce the incidence of adverse outcomes, such as birth trauma and macrosomia. However, this involves intensive monitoring and treatment of all women with GDM. We propose that using medical imaging to identify pregnancies displaying signs of being affected by GDM could help to target management, allowing low-risk women to be spared excessive intervention, and facilitating better resource allocation.
OBJECTIVES
We wanted to address the following question: in women with gestational diabetes, does the use of fetal imaging plus maternal blood glucose concentration to indicate the need for medical management compared with glucose concentration alone reduce the risk of adverse perinatal outcomes?
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (29 January 2019), ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) (both on 29 January 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials, including those published in abstract form only. Studies using a cluster-randomised design and quasi-randomised controlled trials were both eligible for inclusion, but we didn't identify any. Cross-over trials were not eligible for inclusion in our review.We included women carrying singleton pregnancies who were diagnosed with GDM, as defined by the trials' authors. The intervention of interest was the use of fetal biometry on imaging methods in addition to maternal glycaemic values for indicating the use of medical therapy for GDM. The control group was the use of maternal glycaemic values alone for indicating the use of such therapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors extracted data and checked them for accuracy.
MAIN RESULTS
Three randomised controlled trials met the inclusion criteria for our systematic review - the studies randomised a total of 524 women.We assessed the three included studies as being at a low to moderate risk of bias; the nature of the intervention made it difficult to achieve blinding of participants and personnel and none of the trial reports contained information about methods of allocation concealment (and were therefore assessed as being at an unclear risk of selection bias).In all studies, the intervention was the use of fetal biometry on ultrasound to identify fetuses displaying signs of fetal macrosomia, and the use of this information to indicate the use of medical anti-hyperglycaemic treatments. Those pregnancies were subject to more stringent blood glucose targets than those without signs of fetal macrosomia.Maternal outcomesThe use of fetal biometry in addition to maternal blood glucose concentration (compared with maternal blood glucose concentration alone) may make little or no difference to the incidence of caesarean delivery (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.59 to 1.10; 2 trials, 428 women; low-certainty evidence). We are unclear about the results for hypertensive disorders of pregnancy (RR 0.80, 95% CI 0.34 to 1.89; 2 trials, 325 women) due to very low-certainty evidence. The included trials did not report on development of type 2 diabetes in the mother or maternal hypoglycaemia.Fetal and neonatal outcomesThe use of fetal biometry may make little or no difference to the incidence of neonatal hypoglycaemia (RR 0.90, 95% CI 0.57 to 1.42; 3 trials, 524 women; low-certainty evidence). Very low-certainty evidence means that we are unclear about the results for large-for-gestational age (RR 0.81, 95% CI 0.38 to 1.74; 3 trials, 524 women); shoulder dystocia (RR 0.33, 95% CI 0.01 to 7.98; 1 trial, 96 women); a composite measure of perinatal morbidity or mortality (RR 1.00, 95% CI 0.21 to 4.71; 1 study, 96 women); or perinatal mortality (RR 0.33, 95% CI 0.01 to 7.98; 1 trial, 96 women).
AUTHORS' CONCLUSIONS
This review is based on evidence from three trials involving 524 women. The trials did not report some important outcomes of interest to this review, and the majority of our secondary outcomes were also unreported. The available evidence ranged from low- to very low-certainty, with downgrading decisions based on limitations in study design, imprecision and inconsistency.There is insufficient evidence to evaluate the use of fetal biometry (in addition to maternal blood glucose concentration values) to assist in guiding the medical management of GDM, on either maternal or perinatal health outcomes, or the associated costs.More research is required, ideally larger randomised studies which report the maternal and infant short- and long-term outcomes listed in this review, as well as those outcomes relating to financial and resource implications.
Topics: Biometry; Diabetes, Gestational; Female; Fetal Macrosomia; Humans; Insulin; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Randomized Controlled Trials as Topic
PubMed: 31476798
DOI: 10.1002/14651858.CD012544.pub2