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BMJ (Clinical Research Ed.) May 2020To provide an overview and critical appraisal of early warning scores for adult hospital patients.
OBJECTIVE
To provide an overview and critical appraisal of early warning scores for adult hospital patients.
DESIGN
Systematic review.
DATA SOURCES
Medline, CINAHL, PsycInfo, and Embase until June 2019.
ELIGIBILITY CRITERIA FOR STUDY SELECTION
Studies describing the development or external validation of an early warning score for adult hospital inpatients.
RESULTS
13 171 references were screened and 95 articles were included in the review. 11 studies were development only, 23 were development and external validation, and 61 were external validation only. Most early warning scores were developed for use in the United States (n=13/34, 38%) and the United Kingdom (n=10/34, 29%). Death was the most frequent prediction outcome for development studies (n=10/23, 44%) and validation studies (n=66/84, 79%), with different time horizons (the most frequent was 24 hours). The most common predictors were respiratory rate (n=30/34, 88%), heart rate (n=28/34, 83%), oxygen saturation, temperature, and systolic blood pressure (all n=24/34, 71%). Age (n=13/34, 38%) and sex (n=3/34, 9%) were less frequently included. Key details of the analysis populations were often not reported in development studies (n=12/29, 41%) or validation studies (n=33/84, 39%). Small sample sizes and insufficient numbers of event patients were common in model development and external validation studies. Missing data were often discarded, with just one study using multiple imputation. Only nine of the early warning scores that were developed were presented in sufficient detail to allow individualised risk prediction. Internal validation was carried out in 19 studies, but recommended approaches such as bootstrapping or cross validation were rarely used (n=4/19, 22%). Model performance was frequently assessed using discrimination (development n=18/22, 82%; validation n=69/84, 82%), while calibration was seldom assessed (validation n=13/84, 15%). All included studies were rated at high risk of bias.
CONCLUSIONS
Early warning scores are widely used prediction models that are often mandated in daily clinical practice to identify early clinical deterioration in hospital patients. However, many early warning scores in clinical use were found to have methodological weaknesses. Early warning scores might not perform as well as expected and therefore they could have a detrimental effect on patient care. Future work should focus on following recommended approaches for developing and evaluating early warning scores, and investigating the impact and safety of using these scores in clinical practice.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42017053324.
Topics: Adult; Aged; Blood Pressure; Clinical Deterioration; Critical Care; Death; Early Warning Score; Female; Heart Arrest; Heart Rate; Hospitals; Humans; Inpatients; Male; Middle Aged; Oxyhemoglobins; Prognosis; Respiratory Rate; Temperature; United Kingdom; United States
PubMed: 32434791
DOI: 10.1136/bmj.m1501 -
The Cochrane Database of Systematic... Mar 2023Observational studies of increasingly better quality and in different settings suggest that planned hospital birth in many places does not reduce mortality and... (Review)
Review
BACKGROUND
Observational studies of increasingly better quality and in different settings suggest that planned hospital birth in many places does not reduce mortality and morbidity but increases the frequency of interventions and complications. Euro-Peristat (part of the European Union's Health Monitoring Programme) has raised concerns about iatrogenic effects of obstetric interventions, and the World Health Organization (WHO) has raised concern that the increasing medicalisation of childbirth tends to undermine women's own capability to give birth and negatively impacts their childbirth experience. This is an update of a Cochrane Review first published in 1998, and previously updated in 2012.
OBJECTIVES
To compare the effects of planned hospital birth with planned home birth attended by a midwife or others with midwifery skills and backed up by a modern hospital system in case a transfer to hospital should turn out to be necessary. The primary focus is on women with an uncomplicated pregnancy and low risk of medical intervention during birth. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register (which includes trials from CENTRAL, MEDLINE, Embase, CINAHL, WHO ICTRP, and conference proceedings), ClinicalTrials.gov (16 July 2021), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing planned hospital birth with planned home birth in low-risk women as described in the objectives. Cluster-randomised trials, quasi-randomised trials, and trials published only as an abstract were also eligible.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked the data for accuracy. We contacted study authors for additional information. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included one trial involving 11 participants. This was a small feasibility study to show that well-informed women - contrary to common beliefs - were prepared to be randomised. This update did not identify any additional studies for inclusion, but excluded one study that had been awaiting assessment. The included study was at high risk of bias for three out of seven risk of bias domains. The trial did not report on five of the seven primary outcomes, and reported zero events for one primary outcome (caesarean section), and non-zero events for the remaining primary outcome (baby not breastfed). Maternal mortality, perinatal mortality (non-malformed), Apgar < 7 at 5 minutes, transfer to neonatal intensive care unit, and maternal satisfaction were not reported. The overall certainty of the evidence for the two reported primary outcomes was very low according to our GRADE assessment (downgraded two levels for high overall risk of bias (due to high risk of bias arising from lack of blinding, high risk of selective reporting and lack of ability to check for publication bias) and two levels for very serious imprecision (single study with few events)). AUTHORS' CONCLUSIONS: This review shows that for selected, low-risk pregnant women, the evidence from randomised trials to support that planned hospital birth reduces maternal or perinatal mortality, morbidity, or any other critical outcome is uncertain. As the quality of evidence in favour of home birth from observational studies seems to be steadily increasing, it might be just as important to prepare a regularly updated systematic review including observational studies as described in the Cochrane Handbook for Systematic Reviews of Interventions as to attempt to set up new RCTs. As women and healthcare practitioners may be aware of evidence from observational studies, and as the International Federation of Gynecology and Obstetrics and the International Confederation of Midwives collaboratively conclude that there is strong evidence that out-of-hospital birth supported by a registered midwife is safe, equipoise may no longer exist, and randomised trials may now thus be considered unethical or hardly feasible.
Topics: Pregnancy; Infant; Infant, Newborn; Female; Humans; Pregnant Women; Home Childbirth; Systematic Reviews as Topic; Parturition; Perinatal Death; Hospitals
PubMed: 36884026
DOI: 10.1002/14651858.CD000352.pub3 -
The Cochrane Database of Systematic... Jun 2022Acute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been... (Review)
Review
BACKGROUND
Acute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been regularly used to reduce respiratory distress and improve oxygenation in hospitalised patients. Due to the association of prone positioning (lying on the abdomen) with sudden infant death syndrome (SIDS) within the first six months, it is recommended that young infants be placed on their back (supine). However, prone positioning may be a non-invasive way of increasing oxygenation in individuals with acute respiratory distress, and offers a more significant survival advantage in those who are mechanically ventilated. There are substantial differences in respiratory mechanics between adults and infants. While the respiratory tract undergoes significant development within the first two years of life, differences in airway physiology between adults and children become less prominent by six to eight years old. However, there is a reduced risk of SIDS during artificial ventilation in hospitalised infants. Thus, an updated review focusing on positioning for infants and young children with ARDS is warranted. This is an update of a review published in 2005, 2009, and 2012.
OBJECTIVES
To compare the effects of different body positions in hospitalised infants and children with acute respiratory distress syndrome aged between four weeks and 16 years.
SEARCH METHODS
We searched CENTRAL, which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE, Embase, and CINAHL from January 2004 to July 2021.
SELECTION CRITERIA
Randomised controlled trials (RCTs) or quasi-RCTs comparing two or more positions for the management of infants and children hospitalised with ARDS.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from each study. We resolved differences by consensus, or referred to a third contributor to arbitrate. We analysed bivariate outcomes using an odds ratio (OR) and 95% confidence interval (CI). We analysed continuous outcomes using a mean difference (MD) and 95% CI. We used a fixed-effect model, unless heterogeneity was significant (I statistic > 50%), when we used a random-effects model.
MAIN RESULTS
We included six trials: four cross-over trials, and two parallel randomised trials, with 198 participants aged between 4 weeks and 16 years, all but 15 of whom were mechanically ventilated. Four trials compared prone to supine positions. One trial compared the prone position to good-lung dependent (where the person lies on the side of the healthy lung, e.g. if the right lung was healthy, they were made to lie on the right side), and independent (or non-good-lung independent, where the person lies on the opposite side to the healthy lung, e.g. if the right lung was healthy, they were made to lie on the left side) position. One trial compared good-lung independent to good-lung dependent positions. When the prone (with ventilators) and supine positions were compared, there was no information on episodes of apnoea or mortality due to respiratory events. There was no conclusive result in oxygen saturation (SaO MD 0.40 mmHg, 95% CI -1.22 to 2.66; 1 trial, 30 participants; very low certainty evidence); blood gases, PCO (MD 3.0 mmHg, 95% CI -1.93 to 7.93; 1 trial, 99 participants; low certainty evidence), or PO (MD 2 mmHg, 95% CI -5.29 to 9.29; 1 trial, 99 participants; low certainty evidence); or lung function (PaO/FiO ratio; MD 28.16 mmHg, 95% CI -9.92 to 66.24; 2 trials, 121 participants; very low certainty evidence). However, there was an improvement in oxygenation index (FiO% X M/ PaO) with prone positioning in both the parallel trials (MD -2.42, 95% CI -3.60 to -1.25; 2 trials, 121 participants; very low certainty evidence), and the cross-over study (MD -8.13, 95% CI -15.01 to -1.25; 1 study, 20 participants). Derived indices of respiratory mechanics, such as tidal volume, respiratory rate, and positive end-expiratory pressure (PEEP) were reported. There was an apparent decrease in tidal volume between prone and supine groups in a parallel study (MD -0.60, 95% CI -1.05 to -0.15; 1 study, 84 participants; very low certainty evidence). When prone and supine positions were compared in a cross-over study, there were no conclusive results in respiratory compliance (MD 0.07, 95% CI -0.10 to 0.24; 1 study, 10 participants); changes in PEEP (MD -0.70 cm HO, 95% CI -2.72 to 1.32; 1 study, 10 participants); or resistance (MD -0.00, 95% CI -0.05 to 0.04; 1 study, 10 participants). One study reported adverse events. There were no conclusive results for potential harm between groups in extubation (OR 0.57, 95% CI 0.13 to 2.54; 1 trial, 102 participants; very low certainty evidence); obstructions of the endotracheal tube (OR 5.20, 95% CI 0.24 to 111.09; 1 trial, 102 participants; very low certainty evidence); pressure ulcers (OR 1.00, 95% CI 0.41 to 2.44; 1 trial, 102 participants; very low certainty evidence); and hypercapnia (high levels of arterial carbon dioxide; OR 3.06, 95% CI 0.12 to 76.88; 1 trial, 102 participants; very low certainty evidence). One study (50 participants) compared supine positions to good-lung dependent and independent positions. There was no conclusive evidence that PaO was different between supine and good-lung dependent positioning (MD 3.44 mm Hg, 95% CI -23.12 to 30.00; 1 trial, 25 participants; very low certainty evidence). There was also no conclusive evidence for supine position and good-lung independent positioning (MD -2.78 mmHg, 95% CI -28.84, 23.28; 25 participants; very low certainty evidence); or between good-lung dependent and independent positioning (MD 6.22, 95% CI -21.25 to 33.69; 1 trial, 25 participants; very low certainty evidence). As most trials did not describe how possible biases were addressed, the potential for bias in these findings is unclear.
AUTHORS' CONCLUSIONS
Although included studies suggest that prone positioning may offer some advantage, there was little evidence to make definitive recommendations. There appears to be low certainty evidence that positioning improves oxygenation in mechanically ventilated children with ARDS. Due to the increased risk of SIDS with prone positioning and lung injury with artificial ventilation, it is recommended that hospitalised infants and children should only be placed in this position while under continuous cardiorespiratory monitoring.
Topics: Adult; Child; Child, Preschool; Humans; Infant; Infant, Newborn; Patient Positioning; Positive-Pressure Respiration; Respiration, Artificial; Respiratory Distress Syndrome; Sudden Infant Death
PubMed: 35661343
DOI: 10.1002/14651858.CD003645.pub4 -
Nutrients Mar 2020Undernutrition is associated with 45% of total infant deaths, totalling 2.7 million globally per year. The vast majority of the burden is felt in low- and middle-income...
Impact of Infant and Young Child Feeding (IYCF) Nutrition Interventions on Breastfeeding Practices, Growth and Mortality in Low- and Middle-Income Countries: Systematic Review.
Undernutrition is associated with 45% of total infant deaths, totalling 2.7 million globally per year. The vast majority of the burden is felt in low- and middle-income countries (LMICs). This review aims to assess the effectiveness of infant and young child feeding (IYCF) interventions. We searched multiple databases including Cochrane Controlled Trials Register (CENTRAL), MEDLINE, EMBASE. Title/abstract screening and full-text screening and data extraction filtered 77 studies for inclusion. Breastfeeding education interventions ( = 38) showed 20% increase in rates of early initiation of breastfeeding, 102% increase in exclusive breastfeeding (EBF) at 3 months and 53% increase in EBF at 6 months and 24% decreases in diarrheal diseases. Complementary feeding education intervention (n=12) showed a 0.41 standard deviation (SD) increase in WAZ, and 0.25 SD in HAZ in food secure setting. Complementary food provision with or without education (n=17) showed a 0.14 SD increase in HAZ and 36% decrease in stunting. Supplementary food interventions (n=12) showed a significant 0.15 SD increase in WHZ. Subgroup analyses showed healthcare professional led interventions were largely more effective, especially on breastfeeding outcomes. We believe this is a comprehensive review of the existing literature on IYCF studies in LMICs. Though breastfeeding education is well supported in its effectiveness on breastfeeding practices, limited evidence exists for growth outcomes. Supplementation interventions seem to have better effects at improving growth. However, more research is required to reach more substantial conclusions.
Topics: Breast Feeding; Child, Preschool; Developing Countries; Female; Humans; Infant; Infant Death; Infant Nutritional Physiological Phenomena; Male
PubMed: 32164187
DOI: 10.3390/nu12030722 -
Ultrasound in Obstetrics & Gynecology :... Oct 2019To estimate the procedure-related risk of miscarriage after amniocentesis and chorionic villus sampling (CVS) based on a systematic review of the literature and an... (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVE
To estimate the procedure-related risk of miscarriage after amniocentesis and chorionic villus sampling (CVS) based on a systematic review of the literature and an updated meta-analysis.
METHODS
A search of MEDLINE, EMBASE and The Cochrane Library was carried out to identify studies reporting complications following CVS or amniocentesis. Eligible for inclusion were large controlled studies reporting data for pregnancy loss prior to 24 weeks' gestation. Study authors were contacted when required to identify additional necessary data. Data for cases that had an invasive procedure and controls were inputted into contingency tables and the risk of miscarriage was estimated for each study. Summary statistics based on a random-effects model were calculated after taking into account the weighting for each study included in the systematic review. Procedure-related risk of miscarriage was estimated as a weighted risk difference from the summary statistics for cases and controls. Subgroup analyses were performed according to the similarity in risk levels for chromosomal abnormality between the invasive-testing and control groups. Heterogeneity was assessed using the I statistic. Egger's bias was estimated to assess reporting bias in published studies.
RESULTS
The electronic search yielded 2943 potential citations, from which 12 controlled studies for amniocentesis and seven for CVS were selected for inclusion in the systematic review. A total of 580 miscarriages occurred following 63 723 amniocentesis procedures, resulting in a weighted risk of pregnancy loss of 0.91% (95% CI, 0.73-1.09%). In the control group, there were 1726 miscarriages in 330 469 pregnancies with a loss rate of 0.58% (95% CI, 0.47-0.70%). The weighted procedure-related risk of miscarriage following amniocentesis was 0.30% (95% CI, 0.11-0.49%; I = 70.1%). A total of 163 miscarriages occurred following 13 011 CVS procedures, resulting in a risk of pregnancy loss of 1.39% (95% CI, 0.76-2.02%). In the control group, there were 1946 miscarriages in 232 680 pregnancies with a loss rate of 1.23% (95% CI, 0.86-1.59%). The weighted procedure-related risk of miscarriage following CVS was 0.20% (95% CI, -0.13 to 0.52%; I = 52.7%). However, when studies including only women with similar risk profiles for chromosomal abnormality in the intervention and control groups were considered, the procedure-related risk for amniocentesis was 0.12% (95% CI, -0.05 to 0.30%; I = 44.1%) and for CVS it was -0.11% (95% CI, -0.29 to 0.08%; I = 0%).
CONCLUSIONS
The procedure-related risks of miscarriage following amniocentesis and CVS are lower than currently quoted to women. The risk appears to be negligible when these interventions were compared to control groups of the same risk profile. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
Topics: Abortion, Spontaneous; Adult; Amniocentesis; Chorionic Villi Sampling; Chromosome Aberrations; Embryo Loss; Female; Gestational Age; Humans; Pregnancy; Pregnancy Trimester, Second; Prenatal Diagnosis; Randomized Controlled Trials as Topic; Risk Assessment
PubMed: 31124209
DOI: 10.1002/uog.20353 -
The Cochrane Database of Systematic... Oct 2018Antihypertensive drugs are often used in the belief that lowering blood pressure will prevent progression to more severe disease, and thereby improve pregnancy outcome.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Antihypertensive drugs are often used in the belief that lowering blood pressure will prevent progression to more severe disease, and thereby improve pregnancy outcome. This Cochrane Review is an updated review, first published in 2001 and subsequently updated in 2007 and 2014.
OBJECTIVES
To assess the effects of antihypertensive drug treatments for women with mild to moderate hypertension during pregnancy.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (13 September 2017), and reference lists of retrieved studies.
SELECTION CRITERIA
All randomised trials evaluating any antihypertensive drug treatment for mild to moderate hypertension during pregnancy, defined as systolic blood pressure 140 to 169 mmHg and/or diastolic blood pressure 90 to 109 mmHg. Comparisons were of one or more antihypertensive drug(s) with placebo, with no antihypertensive drug, or with another antihypertensive drug, and where treatment was planned to continue for at least seven days.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.
MAIN RESULTS
For this update, we included 63 trials (data from 58 trials, 5909 women), with moderate to high risk of bias overall.We carried out GRADE assessments for the main 'antihypertensive drug versus placebo/no antihypertensive drug' comparison only. Evidence was graded from very low to moderate certainty, with downgrading mainly due to design limitations and imprecision.For many outcomes, trials contributing data evaluated different hypertensive drugs; while we did not downgrade for this indirectness, results should be interpreted with caution.Antihypertensive drug versus placebo/no antihypertensive drug (31 trials, 3485 women)Primary outcomes: moderate-certainty evidence suggests that use of antihypertensive drug(s) probably halves the risk of developing severe hypertension (risk ratio (RR) 0.49; 95% confidence interval (CI) 0.40 to 0.60; 20 trials, 2558 women), but may have little or no effect on the risk of proteinuria/pre-eclampsia (average risk ratio (aRR) 0.92; 95% CI 0.75 to 1.14; 23 trials, 2851 women; low-certainty evidence). Moderate-certainty evidence also shows that antihypertensive drug(s) probably have little or no effect in the risk of total reported fetal or neonatal death (including miscarriage) (aRR 0.72; 95% CI 0.50 to 1.04; 29 trials, 3365 women), small-for-gestational-age babies (aRR 0.96; 95% CI 0.78 to 1.18; 21 trials, 2686 babies) or preterm birth less than 37 weeks (aRR 0.96; 95% CI 0.83 to 1.12; 15 trials, 2141 women).
SECONDARY OUTCOMES
we are uncertain of the effect of antihypertensive drug(s) on the risk of maternal death, severe pre-eclampsia, or eclampsia, orimpaired long-term growth and development of the baby in infancy and childhood, because the certainty of this evidence is very low. There may be little or no effect on the risk of changed/stopped drugs due to maternal side-effects, or admission to neonatal or intensive care nursery (low-certainty evidence). There is probably little or no difference in the risk of elective delivery (moderate-certainty evidence).Antihypertensive drug versus another antihypertensive drug (29 trials, 2774 women)Primary outcomes: beta blockers and calcium channel blockers together in the meta-analysis appear to be more effective than methyldopa in avoiding an episode of severe hypertension (RR 0.70; 95% CI 0.56 to 0.88; 11 trials, 638 women). There was also an increase in this risk when other antihypertensive drugs were compared with calcium channel blockers (RR 1.86; 95% CI 1.09 to 3.15; 5 trials, 223 women), but no evidence of a difference when methyldopa and calcium channel blockers together were compared with beta blockers (RR1.18, 95% CI 0.95 to 1.48; 10 trials, 692 women). No evidence of a difference in the risk of proteinuria/pre-eclampsia was found when alternative drugs were compared with methyldopa (aRR 0.78; 95% CI 0.58 to 1.06; 11 trials, 997 women), with calcium channel blockers (aRR: 1.24, 95% CI 0.70 to 2.19; 5 trials, 375 women), or with beta blockers (aRR 1.21, 95% CI 0.88 to 1.67; 12 trials, 1107 women).For the babies, we found no evidence of a difference in the risk oftotal reported fetal or neonatal death (including miscarriage) when comparing other antihypertensive drugs with methyldopa (aRR 0.77, 95% CI 0.52 to 1.14; 22 trials, 1791 babies), with calcium channel blockers (aRR 0.90, 95% CI 0.52 to 1.57; nine trials, 700 babies), or with beta blockers (aRR: 1.23, 95% CI 0.81 to 1.88; 19 trials, 1652 babies); nor in the risk for small-for-gestational age in the comparison with methyldopa (aRR 0.79, 95% CI 0.52 to 1.20; seven trials, 597 babies), with calcium channel blockers (aRR 1.05, 95% CI 0.64 to 1.73; four trials, 200 babies), or with beta blockers (average RR 1.13, 95% CI 0.80 to 1.60; 7 trials, 680 babies). No evidence of an overall difference among groups in the risk of preterm birth (less than 37 weeks) was found in the comparison with methyldopa (aRR: 0.91; 95% CI 0.68 to 1.22; 11 trials, 835 women), with calcium channel blockers (aRR 0.85, 95% CI 0.59 to 1.23; six trials, 330 women), or with beta blockers (aRR 1.22, 95% CI 0.90 to 1.66; 9 trials, 806 women).
SECONDARY OUTCOMES
There were no cases of maternal death andeclampsia. There is no evidence of a difference in the risk of severe pre-eclampsia, changed/stopped drug due to maternal side-effects, elective delivery, admission to neonatal or intensive care nursery when other antihypertensive drugs are compared with methyldopa, calcium channel blockers or beta blockers. Impaired long-term growth and development in infancy and childhood was not reported for these comparisons.
AUTHORS' CONCLUSIONS
Antihypertensive drug therapy for mild to moderate hypertension during pregnancy reduces the risk of severe hypertension. The effect on other clinically important outcomes remains unclear. If antihypertensive drugs are used, beta blockers and calcium channel blockers appear to be more effective than the alternatives for preventing severe hypertension. High-quality large sample-sized randomised controlled trials are required in order to provide reliable estimates of the benefits and adverse effects of antihypertensive treatment for mild to moderate hypertension for both mother and baby, as well as costs to the health services, women and their families.
Topics: Antihypertensive Agents; Female; Fetal Death; Humans; Hypertension; Infant, Newborn; Infant, Premature; Infant, Small for Gestational Age; Maternal Death; Placebo Effect; Pre-Eclampsia; Pregnancy; Pregnancy Complications, Cardiovascular; Proteinuria; Randomized Controlled Trials as Topic
PubMed: 30277556
DOI: 10.1002/14651858.CD002252.pub4 -
The Cochrane Database of Systematic... Jul 2020Risks of stillbirth or neonatal death increase as gestation continues beyond term (around 40 weeks' gestation). It is unclear whether a policy of labour induction can... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Risks of stillbirth or neonatal death increase as gestation continues beyond term (around 40 weeks' gestation). It is unclear whether a policy of labour induction can reduce these risks. This Cochrane Review is an update of a review that was originally published in 2006 and subsequently updated in 2012 and 2018.
OBJECTIVES
To assess the effects of a policy of labour induction at or beyond 37 weeks' gestation compared with a policy of awaiting spontaneous labour indefinitely (or until a later gestational age, or until a maternal or fetal indication for induction of labour arises) on pregnancy outcomes for the infant and the mother.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (17 July 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) conducted in pregnant women at or beyond 37 weeks, comparing a policy of labour induction with a policy of awaiting spontaneous onset of labour (expectant management). We also included trials published in abstract form only. Cluster-RCTs, quasi-RCTs and trials using a cross-over design were not eligible for inclusion in this review. We included pregnant women at or beyond 37 weeks' gestation. Since risk factors at this stage of pregnancy would normally require intervention, only trials including women at low risk for complications, as defined by trialists, were eligible. The trials of induction of labour in women with prelabour rupture of membranes at or beyond term were not considered in this review but are considered in a separate Cochrane Review.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. Data were checked for accuracy. We assessed the certainty of evidence using the GRADE approach.
MAIN RESULTS
In this updated review, we included 34 RCTs (reporting on over 21,000 women and infants) mostly conducted in high-income settings. The trials compared a policy to induce labour usually after 41 completed weeks of gestation (> 287 days) with waiting for labour to start and/or waiting for a period before inducing labour. The trials were generally at low to moderate risk of bias. Compared with a policy of expectant management, a policy of labour induction was associated with fewer (all-cause) perinatal deaths (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.15 to 0.64; 22 trials, 18,795 infants; high-certainty evidence). There were four perinatal deaths in the labour induction policy group compared with 25 perinatal deaths in the expectant management group. The number needed to treat for an additional beneficial outcome (NNTB) with induction of labour, in order to prevent one perinatal death, was 544 (95% CI 441 to 1042). There were also fewer stillbirths in the induction group (RR 0.30, 95% CI 0.12 to 0.75; 22 trials, 18,795 infants; high-certainty evidence); two in the induction policy group and 16 in the expectant management group. For women in the policy of induction arms of trials, there were probably fewer caesarean sections compared with expectant management (RR 0.90, 95% CI 0.85 to 0.95; 31 trials, 21,030 women; moderate-certainty evidence); and probably little or no difference in operative vaginal births with induction (RR 1.03, 95% CI 0.96 to 1.10; 22 trials, 18,584 women; moderate-certainty evidence). Induction may make little or difference to perineal trauma (severe perineal tear: RR 1.04, 95% CI 0.85 to 1.26; 5 trials; 11,589 women; low-certainty evidence). Induction probably makes little or no difference to postpartum haemorrhage (RR 1.02, 95% CI 0.91 to 1.15, 9 trials; 12,609 women; moderate-certainty evidence), or breastfeeding at discharge (RR 1.00, 95% CI 0.96 to 1.04; 2 trials, 7487 women; moderate-certainty evidence). Very low certainty evidence means that we are uncertain about the effect of induction or expectant management on the length of maternal hospital stay (average mean difference (MD) -0.19 days, 95% CI -0.56 to 0.18; 7 trials; 4120 women; Tau² = 0.20; I² = 94%). Rates of neonatal intensive care unit (NICU) admission were lower (RR 0.88, 95% CI 0.80 to 0.96; 17 trials, 17,826 infants; high-certainty evidence), and probably fewer babies had Apgar scores less than seven at five minutes in the induction groups compared with expectant management (RR 0.73, 95% CI 0.56 to 0.96; 20 trials, 18,345 infants; moderate-certainty evidence). Induction or expectant management may make little or no difference for neonatal encephalopathy (RR 0.69, 95% CI 0.37 to 1.31; 2 trials, 8851 infants; low-certainty evidence, and probably makes little or no difference for neonatal trauma (RR 0.97, 95% CI 0.63 to 1.49; 5 trials, 13,106 infants; moderate-certainty evidence) for induction compared with expectant management. Neurodevelopment at childhood follow-up and postnatal depression were not reported by any trials. In subgroup analyses, no differences were seen for timing of induction (< 40 versus 40-41 versus > 41 weeks' gestation), by parity (primiparous versus multiparous) or state of cervix for any of the main outcomes (perinatal death, stillbirth, NICU admission, caesarean section, operative vaginal birth, or perineal trauma).
AUTHORS' CONCLUSIONS
There is a clear reduction in perinatal death with a policy of labour induction at or beyond 37 weeks compared with expectant management, though absolute rates are small (0.4 versus 3 deaths per 1000). There were also lower caesarean rates without increasing rates of operative vaginal births and there were fewer NICU admissions with a policy of induction. Most of the important outcomes assessed using GRADE had high- or moderate-certainty ratings. While existing trials have not yet reported on childhood neurodevelopment, this is an important area for future research. The optimal timing of offering induction of labour to women at or beyond 37 weeks' gestation needs further investigation, as does further exploration of risk profiles of women and their values and preferences. Offering women tailored counselling may help them make an informed choice between induction of labour for pregnancies, particularly those continuing beyond 41 weeks - or waiting for labour to start and/or waiting before inducing labour.
Topics: Cesarean Section; Female; Gestational Age; Humans; Infant; Infant Mortality; Infant, Newborn; Intensive Care Units, Neonatal; Labor, Induced; Perinatal Death; Pregnancy; Pregnancy, Prolonged; Randomized Controlled Trials as Topic; Risk; Stillbirth; Watchful Waiting
PubMed: 32666584
DOI: 10.1002/14651858.CD004945.pub5 -
The Cochrane Database of Systematic... Mar 2017Current management of preterm prelabour rupture of the membranes (PPROM) involves either initiating birth soon after PPROM or, alternatively, adopting a 'wait and see'... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Current management of preterm prelabour rupture of the membranes (PPROM) involves either initiating birth soon after PPROM or, alternatively, adopting a 'wait and see' approach (expectant management). It is unclear which strategy is most beneficial for mothers and their babies. This is an update of a Cochrane review published in 2010 (Buchanan 2010).
OBJECTIVES
To assess the effect of planned early birth versus expectant management for women with preterm prelabour rupture of the membranes between 24 and 37 weeks' gestation for fetal, infant and maternal well being.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (30 September 2016), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials comparing planned early birth with expectant management for women with PPROM prior to 37 weeks' gestation. We excluded quasi-randomised trials.
DATA COLLECTION AND ANALYSIS
Two review authors independently evaluated trials for inclusion into the review and for methodological quality. Two review authors independently extracted data. We checked data for accuracy. We assessed the quality of evidence using the GRADE approach.
MAIN RESULTS
We included 12 trials in the review (3617 women and 3628 babies). For primary outcomes, we identified no clear differences between early birth and expectant management in neonatal sepsis (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.66 to 1.30, 12 trials, 3628 babies, evidence graded moderate), or proven neonatal infection with positive blood culture (RR 1.24, 95% CI 0.70 to 2.21, seven trials, 2925 babies). However, early birth increased the incidence of respiratory distress syndrome (RDS) (RR 1.26, 95% CI 1.05 to 1.53, 12 trials, 3622 babies, evidence graded high). Early birth was also associated with an increased rate of caesarean section (RR 1.26, 95% CI 1.11 to 1.44, 12 trials, 3620 women, evidence graded high).Assessment of secondary perinatal outcomes showed no clear differences in overall perinatal mortality (RR 1.76, 95% CI 0.89 to 3.50, 11 trials, 3319 babies), or intrauterine deaths (RR 0.45, 95% CI 0.13 to 1.57, 11 trials, 3321 babies) when comparing early birth with expectant management. However, early birth was associated with a higher rate of neonatal death (RR 2.55, 95% CI 1.17 to 5.56, 11 trials, 3316 babies) and need for ventilation (RR 1.27, 95% CI 1.02 to 1.58, seven trials, 2895 babies, evidence graded high). Babies of women randomised to early birth were delivered at a gestational age lower than those randomised to expectant management (mean difference (MD) -0.48 weeks, 95% CI -0.57 to -0.39, eight trials, 3139 babies). Admission to neonatal intensive care was more likely for those babies randomised to early birth (RR 1.16, 95% CI 1.08 to 1.24, four trials, 2691 babies, evidence graded moderate).In assessing secondary maternal outcomes, we found that early birth was associated with a decreased rate of chorioamnionitis (RR 0.50, 95% CI 0.26 to 0.95, eight trials, 1358 women, evidence graded moderate), and an increased rate of endometritis (RR 1.61, 95% CI 1.00 to 2.59, seven trials, 2980 women). As expected due to the intervention, women randomised to early birth had a higher chance of having an induction of labour (RR 2.18, 95% CI 2.01 to 2.36, four trials, 2691 women). Women randomised to early birth had a decreased total length of hospitalisation (MD -1.75 days, 95% CI -2.45 to -1.05, six trials, 2848 women, evidence graded moderate).Subgroup analyses indicated improved maternal and infant outcomes in expectant management in pregnancies greater than 34 weeks' gestation, specifically relating to RDS and maternal infections. The use of prophylactic antibiotics were shown to be effective in reducing maternal infections in women randomised to expectant management.Overall, we assessed all 12 studies as being at low or unclear risk of bias. Some studies lacked an adequate description of methods and the risk of bias could only be assessed as unclear. In five of the studies there were one and/or two domains where the risk of bias was judged as high. GRADE profiling showed the quality of evidence across all critical outcomes to be moderate to high.
AUTHORS' CONCLUSIONS
With the addition of five randomised controlled trials (2927 women) to this updated review, we found no clinically important difference in the incidence of neonatal sepsis between women who birth immediately and those managed expectantly in PPROM prior to 37 weeks' gestation. Early planned birth was associated with an increase in the incidence of neonatal RDS, need for ventilation, neonatal mortality, endometritis, admission to neonatal intensive care, and the likelihood of birth by caesarean section, but a decreased incidence of chorioamnionitis. Women randomised to early birth also had an increased risk of labour induction, but a decreased length of hospital stay. Babies of women randomised to early birth were more likely to be born at a lower gestational age.In women with PPROM before 37 weeks' gestation with no contraindications to continuing the pregnancy, a policy of expectant management with careful monitoring was associated with better outcomes for the mother and baby.The direction of future research should be aimed at determining which groups of women with PPROM would not benefit from expectant management. This could be determined by analysing subgroups according to gestational age at presentation, corticosteroid usage, and abnormal vaginal microbiological colonisation. Research should also evaluate long-term neurodevelopmental outcomes of infants.
Topics: Cesarean Section; Chorioamnionitis; Delivery, Obstetric; Female; Fetal Death; Fetal Membranes, Premature Rupture; Gestational Age; Humans; Infant, Newborn; Intensive Care Units, Neonatal; Labor Onset; Length of Stay; Perinatal Mortality; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Sepsis; Watchful Waiting
PubMed: 28257562
DOI: 10.1002/14651858.CD004735.pub4 -
Age and Ageing Jan 2024Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) reduce cardio-metabolic and renal outcomes in patients with type 2 diabetes (T2D) but their efficacy and safety in... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) reduce cardio-metabolic and renal outcomes in patients with type 2 diabetes (T2D) but their efficacy and safety in older or frail individuals remains unclear.
METHODS
We searched PubMed, Scopus, Web of Science, Cochrane CENTRA and Google Scholar and selected randomised controlled trials and observational studies comparing SGLT2Is versus placebo/other glucose-lowering agent for people with frailty or older individuals (>65 years) with T2D and heart failure (HF). Extracted data on the change in HbA1c % and safety outcomes were pooled in a random-effects meta-analysis model.
RESULTS
We included data from 20 studies (22 reports; N = 77,083 patients). SGLT2Is did not significantly reduce HbA1c level (mean difference -0.13, 95%CI: -0.41 to 0.14). SGLT2Is were associated with a significant reduction in the risk of all-cause mortality (risk ratio (RR) 0.81, 95%CI: -0.69 to 0.95), cardiac death (RR 0.80, 95%CI: -0.94 to 0.69) and hospitalisation for heart failure (HHF) (RR 0.69, 95%CI: 0.59-0.81). However, SGLT2Is did not demonstrate significant effect in reducing in the risk of macrovascular events (acute coronary syndrome or cerebral vascular occlusion), renal progression/composite renal endpoint, acute kidney injury, worsening HF, atrial fibrillation or diabetic ketoacidosis.
CONCLUSIONS
In older or frail patients with T2D and HF, SGLT2Is are consistently linked with a decrease in total mortality and the overall burden of cardiovascular (CV) events, including HHF events and cardiac death, but not protective for macrovascular death or renal events. Adverse events were more difficult to quantify but the risk of diabetic ketoacidosis or acute kidney injury was not significantly increase.
Topics: Humans; Aged; Diabetes Mellitus, Type 2; Sodium-Glucose Transporter 2 Inhibitors; Glycated Hemoglobin; Diabetic Ketoacidosis; Sodium-Glucose Transporter 2; Frail Elderly; Heart Failure; Death; Glucose; Sodium
PubMed: 38287703
DOI: 10.1093/ageing/afad254 -
Bulletin of the World Health... Jan 2023To understand the experiences and perceptions of people implementing maternal and/or perinatal death surveillance and response in low- and middle-income countries, and... (Review)
Review
OBJECTIVE
To understand the experiences and perceptions of people implementing maternal and/or perinatal death surveillance and response in low- and middle-income countries, and the mechanisms by which this process can achieve its intended outcomes.
METHODS
In June 2022, we systematically searched seven databases for qualitative studies of stakeholders implementing maternal and/or perinatal death surveillance and response in low- and middle-income countries. Two reviewers independently screened articles and assessed their quality. We used thematic synthesis to derive descriptive themes and a realist approach to understand the context-mechanism-outcome configurations.
FINDINGS
Fifty-nine studies met the inclusion criteria. Good outcomes (improved quality of care or reduced mortality) were underpinned by a functional action cycle. Mechanisms for effective death surveillance and response included learning, vigilance and implementation of recommendations which motivated further engagement. The key context to enable effective death surveillance and response was a blame-free learning environment with good leadership. Inadequate outcomes (lack of improvement in care and mortality and discontinuation of death surveillance and response) resulted from a vicious cycle of under-reporting, inaccurate data, and inadequate review and recommendations, which led to demotivation and disengagement. Some harmful outcomes were reported, such as inappropriate referrals and worsened staff shortages, which resulted from a fear of negative consequences, including blame, disciplinary action or litigation.
CONCLUSION
Conditions needed for effective maternal and/or perinatal death surveillance and response include: separation of the process from litigation and disciplinary procedures; comprehensive guidelines and training; adequate resources to implement recommendations; and supportive supervision to enable safe learning.
Topics: Pregnancy; Female; Humans; Perinatal Death; Family; Learning; Qualitative Research; Social Problems; Maternal Death
PubMed: 36593778
DOI: 10.2471/BLT.22.288703