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Antenatal magnesium sulphate and adverse neonatal outcomes: A systematic review and meta-analysis.

ABSTRACT: BACKGROUND:There is widespread, increasing use of magnesium sulphate in obstetric practice for pre-eclampsia, eclampsia, and preterm fetal neuroprotection; benefit for preventing preterm labour and birth (tocolysis) is unproven. We conducted a systematic review and meta-analysis to assess whether antenatal magnesium sulphate is associated with unintended adverse neonatal outcomes. METHODS AND FINDINGS:CINAHL, Cochrane Library, LILACS, MEDLINE, Embase, TOXLINE, and Web of Science, were searched (inceptions to 3 September 2019). Randomised, quasi-randomised, and non-randomised trials, cohort and case-control studies, and case reports assessing antenatal magnesium sulphate for pre-eclampsia, eclampsia, fetal neuroprotection, or tocolysis, compared with placebo/no treatment or a different magnesium sulphate regimen, were included. The primary outcome was perinatal death. Secondary outcomes included pre-specified and non-pre-specified adverse neonatal outcomes. Two reviewers screened 5,890 articles, extracted data, and assessed risk of bias following Cochrane Handbook and RTI Item Bank guidance. For randomised trials, pooled risk ratios (RRs) or mean differences, with 95% confidence intervals (CIs), were calculated using fixed- or random-effects meta-analysis. Non-randomised data were tabulated and narratively summarised. We included 197 studies (40 randomised trials, 138 non-randomised studies, and 19 case reports), of mixed quality. The 40 trials (randomising 19,265 women and their babies) were conducted from 1987 to 2018 across high- (16 trials) and low/middle-income countries (23 trials) (1 mixed). Indications included pre-eclampsia/eclampsia (24 trials), fetal neuroprotection (7 trials), and tocolysis (9 trials); 18 trials compared magnesium sulphate with placebo/no treatment, and 22 compared different regimens. For perinatal death, no clear difference in randomised trials was observed between magnesium sulphate and placebo/no treatment (RR 1.01; 95% CI 0.92 to 1.10; 8 trials, 13,654 babies), nor between regimens. Eleven of 138 non-randomised studies reported on perinatal death. Only 1 cohort (127 babies; moderate to high risk of bias) observed an increased risk of perinatal death with >48 versus ?48 grams magnesium sulphate exposure for tocolysis. No clear secondary adverse neonatal outcomes were observed in randomised trials, and a very limited number of possible adverse outcomes warranting further consideration were identified in non-randomised studies. Where non-randomised studies observed possible harms, often no or few confounders were controlled for (moderate to high risk of bias), samples were small (200 babies or fewer), and/or results were from subgroup analyses. Limitations include missing data for important outcomes across most studies, heterogeneity of included studies, and inclusion of published data only. CONCLUSIONS:Our findings do not support clear associations between antenatal magnesium sulphate for beneficial indications and adverse neonatal outcomes. Further large, high-quality studies (prospective cohorts or individual participant data meta-analyses) assessing specific outcomes, or the impact of regimen, pregnancy, or birth characteristics on these outcomes, would further inform safety recommendations. PROSPERO: CRD42013004451.

SUBMITTER: Shepherd E

PROVIDER: S-EPMC6897495 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Antenatal magnesium sulphate and adverse neonatal outcomes: A systematic review and meta-analysis.

Shepherd Emily E Shepherd Emily E Salam Rehana A RA Manhas Deepak D Synnes Anne A Middleton Philippa P Makrides Maria M Crowther Caroline A CA

PLoS medicine 20191206 12

<h4>Background</h4>There is widespread, increasing use of magnesium sulphate in obstetric practice for pre-eclampsia, eclampsia, and preterm fetal neuroprotection; benefit for preventing preterm labour and birth (tocolysis) is unproven. We conducted a systematic review and meta-analysis to assess whether antenatal magnesium sulphate is associated with unintended adverse neonatal outcomes.<h4>Methods and findings</h4>CINAHL, Cochrane Library, LILACS, MEDLINE, Embase, TOXLINE, and Web of Science, ...[more]

PMID: 31809499

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Project description:BackgroundAntenatal magnesium sulphate, widely used in obstetrics to improve maternal and infant outcomes, may be associated with adverse effects for the mother sufficient for treatment cessation. This systematic review aimed to quantify maternal adverse effects attributed to treatment, assess how adverse effects vary according to different regimens, and explore women's experiences with this treatment.MethodsBibliographic databases were searched from their inceptions to July 2012 for studies of any design that reported on maternal adverse effects associated with antenatal magnesium sulphate given to improve maternal or infant outcomes. Primary outcomes were life-threatening adverse effects of treatment (death, cardiac arrest, respiratory arrest). For randomised controlled trials, data were meta-analysed, and risk ratios (RR) pooled using fixed-effects or random-effects models. For non-randomised studies, data were tabulated by design, and presented as RR, odds ratios or percentages, and summarised narratively.ResultsA total of 143 publications were included (21 randomised trials, 15 non-randomised comparative studies, 32 case series and 75 reports of individual cases), of mixed methodological quality. Compared with placebo or no treatment, magnesium sulphate was not associated with an increased risk of maternal death, cardiac arrest or respiratory arrest. Magnesium sulphate significantly increased the risk of 'any adverse effects' overall (RR 4.62, 95% CI 2.42-8.83; 4 trials, 13,322 women), and treatment cessation due to adverse effects (RR 2.77; 95% CI 2.32-3.30; 5 trials, 13,666 women). Few subgroup differences were observed (between indications for use and treatment regimens). In one trial, a lower dose regimen (2 g/3 hours) compared with a higher dose regimen (5 g/4 hours) significantly reduced treatment cessation (RR 0.05; 95% CI 0.01-0.39, 126 women). Adverse effect estimates from studies of other designs largely supported data from randomised trials. Case reports supported an association between iatrogenic overdose of magnesium sulphate and life-threatening consequences.ConclusionsAppropriate administration of antenatal magnesium sulphate was not shown to be associated with serious maternal adverse effects, though an increase in 'minor' adverse effects and treatment cessation was shown. Larger trials are needed to determine optimal regimens, achieving maximal effectiveness with minimal adverse effects, for each antenatal indication for use. Vigilance in the use of magnesium sulphate is essential for women's safety.

Project description:BackgroundNeonatal mortality is one of the major public health problems throughout the world and most notably in developing countries. There exist inconclusive findings on the effect of antenatal care visits on neonatal death worldwide. Thus, the aim of this systematic review and meta-analysis was to reveal the pooled effect of antenatal care visits on neonatal death.MethodsThe present systematic review and meta-analysis was performed using published literature, which was accessed from national and international databases such as, Medline/PubMed, EMBASE, CINAHL, Cochrane Central library, Google Scholar, and HINARI. STATA/SE for windows version 13 software was used to calculate the pooled effect size with 95% confidence intervals (95% CI) of maternal antenatal care visits on neonatal death using the DerSimonian and Laird random effects meta-analysis (random effects model), and results were displayed using forest plot. Statistical heterogeneity was checked using the Cochran Q test (chi-squared statistic) and I2 test statistic and by visual examination of the forest plot.ResultsA total of 18 studies, which fulfilled the inclusion criteria, were included in the present systematic review and meta-analysis. The finding of the present systematic review and meta-analysis revealed that antenatal care visits decrease the risk of neonatal mortality [pooled effect size 0.66 (95% CI, 0.54, 0.80)]. Cochrane Q test (P?<?0.001) revealed no significant heterogeneity among included studies, but I2 statistic revealed sizeable heterogeneity up to 80.5% (I2?=?80.5%). In the present meta-analysis traditional funnel plot, Egger’s weighted regression (P?=?0.48) as well as Begg’s rank correlation statistic (P?=?0.47) revealed no evidence of publication bias.ConclusionsThe present systematic review and meta-analysis revealed that antenatal care visits were significantly associated with lower rates of neonatal death. The risk of neonatal death was significantly reduced by 34% among newborns delivered from mothers who had antenatal care visits. Thus, visiting antenatal care clinics during pregnancy is strongly recommended especially in resource-limited settings like countries of sub-Saharan Africa.Electronic supplementary materialThe online version of this article (10.1186/s40985-018-0110-y) contains supplementary material, which is available to authorized users.

Project description:STUDY QUESTION:How is endometriosis associated with adverse maternal, fetal and neonatal outcomes of pregnancy? SUMMARY ANSWER:Women with endometriosis are at elevated risk for serious and important adverse maternal (pre-eclampsia, gestational diabetes, placenta praevia and Cesarean section) and fetal or neonatal outcomes (preterm birth, PPROM, small for gestational age, stillbirth and neonatal death). WHAT IS KNOWN ALREADY:A number of studies have shown an association between endometriosis and certain adverse maternal and fetal outcomes, but the results have been conflicting with potential for confounding by the use of assisted reproductive technology. STUDY DESIGN, SIZE, DURATION:A systematic review and meta-analysis of observational studies (1 January 1990-31 December 2017) that evaluated the effect of endometriosis on maternal, fetal and neonatal outcomes was conducted. PARTICIPANTS/MATERIALS, SETTING, METHODS:Studies were considered for inclusion if they were prospective or retrospective cohort or case-control studies; included women greater than 20 weeks gestational age with endometriosis; included a control group of gravid women without endometriosis; and, reported at least one of the outcomes of interest. Each study was reviewed for inclusion, data were extracted and risk of bias was assessed by two independent reviewers. MAIN RESULTS AND THE ROLE OF CHANCE:The search strategy identified 33 studies (sample size, n = 3 280 488) for inclusion. Compared with women without endometriosis, women with endometriosis had higher odds of pre-eclampsia (odds ratio [OR] = 1.18 [1.01-1.39]), gestational hypertension and/or pre-eclampsia (OR = 1.21 [1.05-1.39]), gestational diabetes (OR = 1.26 [1.03-1.55]), gestational cholestasis (OR = 4.87 [1.85-12.83]), placenta praevia (OR = 3.31 [2.37, 4.63]), antepartum hemorrhage (OR = 1.69 [1.38-2.07]), antepartum hospital admissions (OR = 3.18 [2.60-3.87]), malpresentation (OR = 1.71 [1.34, 2.18]), labor dystocia (OR = 1.45 [1.04-2.01]) and cesarean section (OR = 1.86 [1.51-2.29]). Fetuses and neonates of women with endometriosis were also more likely to have preterm premature rupture of membranes (OR = 2.33 [1.39-3.90]), preterm birth (OR = 1.70 [1.40-2.06]), small for gestational age <10th% (OR = 1.28 [1.11-1.49]), NICU admission (OR = 1.39 [1.08-1.78]), stillbirth (OR = 1.29 [1.10, 1.52]) and neonatal death (MOR = 1.78 [1.46-2.16]). Among the subgroup of women who conceived spontaneously, endometriosis was found to be associated with placenta praevia, cesarean section, preterm birth and low birth weight. Among the subgroup of women who conceived with the use of assisted reproductive technology, endometriosis was found to be associated with placenta praevia and preterm birth. LIMITATIONS, REASONS FOR CAUTION:As with any systematic review, the review is limited by the quality of the included studies. The diagnosis for endometriosis and the selection of comparison groups were not uniform across studies. However, the effect of potential misclassification would be bias towards the null hypothesis. WIDER IMPLICATIONS OF THE FINDINGS:The association between endometriosis with the important and serious pregnancy outcomes observed in our meta-analysis, in particular stillbirth and neonatal death, is concerning and warrants further studies to elucidate the mechanisms for the observed findings. STUDY FUNDING/COMPETING INTEREST(S):Dr Shifana Lalani is supported by a Physicians' Services Incorporated Foundation Research Grant, and Dr Innie Chen is supported by a University of Ottawa Clinical Research Chair in Reproductive Population Health and Health Services. Dr Singh declares conflicts of interests with Bayer, Abvie, Allergan and Cooper Surgical. All other authors have no conflicts of interests to declare. REGISTRATION NUMBER:PROSPERO CRD42015013911.

Project description:Background and Objective: Fetal growth restriction (FGR) is a pathological condition in which the fetus cannot reach its expected growth potential. When it is diagnosed as a suspected FGR, it remains an unsolved problem whether to direct induction or continue expectant management. To effectively reduce the incidence of neonatal adverse outcomes, we aimed to evaluate whether either method was associated with a lower incidence of neonatal adverse outcomes. Methods: We searched the relevant literature through the PubMed, Web of Science, and Cochrane Library from inception to January 10, 2020. We defined induction as the experimental group and expectant management as the control group. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using random-effects models owing to heterogeneity. Furthermore, we conducted a sensitivity analysis to explore the robustness of the included literature. We used the Newcastle-Ottawa scale (NOS) to evaluate the quality of the available studies. We applied the funnel plot to describe the publication bias. Additionally, subgroup analysis based on the study method, sample size, area, NOS score, Apgar score <7 at 5 min, definition of suspected FGR, severity, and neonatal adverse outcomes were performed to further evaluate the differences between the induction and expectant management. Results: Our study included a total of eight articles with 6,706 patients, which consisted of four randomized controlled trials (RCTs), three retrospective cohort studies, and one prospective cohort study. The total pooled OR and 95% CI between the induction group and the expected management group was 1.38 (95% CI, 0.84-2.28) in the random model. The heterogeneity was I 2 = 84%, P < 0.01. The sensitivity analysis showed that the neonatal adverse outcomes of induction vs. expectant management still presented similar outcomes after omitting of any one of these studies. The funnel plot and linear regression equation showed that there was no publication bias in our study (P = 0.75). Subgroup analysis showed that induction increased the neonatal adverse outcome risks of hypoglycemia and respiratory insufficiency (ORneonatal hypoglycaemia = 8.76, 95% CI: 2.57-29.90; ORrespiratory insufficiency = 1.74, 95% CI: 1.35-2.24, respectively). However, no significant differences were observed based on the other subgroups (all P > 0.05). Conclusion: Regardless of induction or expectant management of a suspected FGR, the neonatal adverse outcomes showed no obvious differences. More studies should be conducted and confounding factors should be taken into consideration to elucidate the differential outcomes of the two approaches for suspected FGR.

Project description:BACKGROUND:Depression in pregnancy (antenatal depression) in many low and middle-income countries is not well documented and has not been given priority for intervention due to competing urgencies and the belief that it does not immediately cause fatalities, which mainly emanated from lack of comprehensive research on the area. To fill this research gap, this systematic review was conducted to investigate the burden of antenatal depression and its consequences on birth outcomes in low- and middle-income countries. METHODS:We systematically searched the databases: CINHAL, MEDLINE, EMCare, PubMed, PSyc Info, Psychiatry online, and Scopus for studies conducted in low and middle-income countries about antenatal depression and its association with adverse birth outcomes. We have included observational studies (case control, cross-sectional and cohort studies), written in English-language, scored in the range of "good quality" on the Newcastle Ottawa Scale (NOS), and were published between January 1, 2007 and December 31, 2017. Studies were excluded if a standardized approach was not used to measure main outcomes, they were conducted on restricted (high risk) populations, or had fair to poor quality score on NOS. We used Higgins and Egger's to test for heterogeneity and publication bias. Primary estimates were pooled using a random effect meta-analysis. The study protocol was registered in PROSPERO with protocol number CRD42017082624. RESULT:We included 64 studies (with 44, 035 women) on antenatal depression and nine studies (with 5,540 women) on adverse birth outcomes. Antenatal depression was higher in the lower-income countries (Pooled Prevalence (PP) = 34.0%; 95%CI: 33.1%-34.9%) compared to the middle-income countries (PP = 22.7%, 95%CI: 20.1%-25.2%) and increased over the three trimesters. Pregnant women with a history of economic difficulties, poor marital relationships, common mental disorders, poor social support, bad obstetric history, and exposure to violence were more likely to report antenatal depression. The risk of having preterm birth (2.41; 1.47-3.56) and low birth weight (1.66; 1.06-2.61) was higher in depressed mothers compared to mothers without depression. CONCLUSIONS:Antenatal depression was higher in low-income countries than in middle-income countries and was found to be a risk factor for low birth weight and preterm births. The economic, maternal, and psychosocial risk factors were responsible for the occurrence of antenatal depression. While there could be competing priority agenda to juggle for health policymakers in low-income countries, interventions for antenatal depression should be reprioritized as vitally important in order to prevent the poor maternal and perinatal outcomes identified in this review.

Project description:ObjectivesThe low COVID-19 vaccine uptake rate among pregnant women is mainly due to safety concerns about COVID-19 vaccines due to limited safety evidence. Our goal was to evaluate the safety of COVID-19 vaccination during pregnancy with up-to-date evidence.MethodsA comprehensive search of MEDLINE, EMBASE, the Cochrane Library, and clinicaltrials.gov was performed on April 5th, 2022, and updated on May 25th, 2022. Studies evaluating the association of COVID-19 vaccination during pregnancy with adverse maternal and neonatal outcomes were included. Two reviewers independently performed the risk of bias assessment and data extraction. Inverse variance random effect meta-analyses were performed to pool outcome data.ResultsForty-three observational studies were included. COVID-19 vaccination [96,384 (73.9%) BNT162b2, 30,889 (23.7%) mRNA-1273, and 3,172 (2.4%) other types] during pregnancy [23,721 (18.3%) in the first trimester, 52,778 (40.5%) in the second trimester, and 53,886 (41.2%) in the third trimester].was associated with reduced risks of stillbirth or neonatal death (OR, 0.74; 95% CI, 0.60-0.92). Sensitivity analysis restricted to studies in participants without COVID-19 showed that the pooled effect was not robust. COVID-19 vaccination during pregnancy was not associated with congenital anomalies (OR, 0.83; 95% CI, 0.63-1.08), preterm birth (OR, 0.98; 95% CI, 0.90-1.06), NICU admission or hospitalization (OR, 0.94; 95% CI, 0.84-1.04), an Apgar score at 5 min <7 (OR, 0.93; 95% CI, 0.86-1.01), low birth weight (OR, 1.00; 95% CI, 0.88-1.14), miscarriage (OR, 0.99; 95% CI, 0.88-1.11), cesarean delivery (OR, 1.07; 95% CI, 0.96-1.19), or postpartum hemorrhage (OR, 0.91; 95% CI, 0.81-1.01).ConclusionsCOVID-19 vaccination during pregnancy was not associated with any of the adverse neonatal or maternal outcomes studied. Interpretation of study findings is limited by the types and timing of vaccination. The vaccinations in our study received during pregnancy were primarily mRNA vaccines administered in the second and third trimester. Future RCTs and meta-analysis are warranted to evaluate the efficacy and long-term effects of the COVID-19 vaccines.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022322525, identifier: PROSPERO, CRD42022322525.

Project description:Objectives To assess the association between maternal glucose concentrations and adverse perinatal outcomes in women without gestational or existing diabetes and to determine whether clear thresholds for identifying women at risk of perinatal outcomes can be identified.Design Systematic review and meta-analysis of prospective cohort studies and control arms of randomised trials.Data sources Databases including Medline and Embase were searched up to October 2014 and combined with individual participant data from two additional birth cohorts.Eligibility criteria for selecting studies Studies including pregnant women with oral glucose tolerance (OGTT) or challenge (OGCT) test results, with data on at least one adverse perinatal outcome.Appraisal and data extraction Glucose test results were extracted for OGCT (50 g) and OGTT (75 g and 100 g) at fasting and one and two hour post-load timings. Data were extracted on induction of labour; caesarean and instrumental delivery; pregnancy induced hypertension; pre-eclampsia; macrosomia; large for gestational age; preterm birth; birth injury; and neonatal hypoglycaemia. Risk of bias was assessed with a modified version of the critical appraisal skills programme and quality in prognostic studies tools.Results 25 reports from 23 published studies and two individual participant data cohorts were included, with up to 207 172 women (numbers varied by the test and outcome analysed in the meta-analyses). Overall most studies were judged as having a low risk of bias. There were positive linear associations with caesarean section, induction of labour, large for gestational age, macrosomia, and shoulder dystocia for all glucose exposures across the distribution of glucose concentrations. There was no clear evidence of a threshold effect. In general, associations were stronger for fasting concentration than for post-load concentration. For example, the odds ratios for large for gestational age per 1 mmol/L increase of fasting and two hour post-load glucose concentrations (after a 75 g OGTT) were 2.15 (95% confidence interval 1.60 to 2.91) and 1.20 (1.13 to 1.28), respectively. Heterogeneity was low between studies in all analyses.Conclusions This review and meta-analysis identified a large number of studies in various countries. There was a graded linear association between fasting and post-load glucose concentration across the whole glucose distribution and most adverse perinatal outcomes in women without pre-existing or gestational diabetes. The lack of a clear threshold at which risk increases means that decisions regarding thresholds for diagnosing gestational diabetes are somewhat arbitrary. Research should now investigate the clinical and cost-effectiveness of applying different glucose thresholds for diagnosis of gestational diabetes on perinatal and longer term outcomes.Systematic review registration PROSPERO CRD42013004608.

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Antenatal magnesium sulphate and adverse neonatal outcomes: A systematic review and meta-analysis.

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Antenatal magnesium sulphate and adverse neonatal outcomes: A systematic review and meta-analysis.

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