-
Ultrasound in Obstetrics & Gynecology :... Sep 2019To determine accurate estimates of risks of maternal and neonatal complications in pregnancies with fetal macrosomia by performing a systematic review of the literature... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To determine accurate estimates of risks of maternal and neonatal complications in pregnancies with fetal macrosomia by performing a systematic review of the literature and meta-analysis.
METHODS
A search of MEDLINE, EMBASE, CINAHL and The Cochrane Library was performed to identify relevant studies reporting on maternal and/or neonatal complications in pregnancies with macrosomia having a birth weight (BW) > 4000 g and/or those with birth weight > 4500 g. Prospective and retrospective cohort and population-based studies that provided data regarding both cases and controls were included. Maternal outcomes assessed were emergency Cesarean section (CS), postpartum hemorrhage (PPH) and obstetric anal sphincter injury (OASIS). Neonatal outcomes assessed were shoulder dystocia, obstetric brachial plexus injury (OBPI) and birth fractures. Meta-analysis using a random-effects model was used to estimate weighted pooled estimates of summary statistics (odds ratio (OR) and 95% CI) for each complication, according to birth weight. Heterogeneity between studies was estimated using Cochran's Q, I statistic and funnel plots.
RESULTS
Seventeen studies reporting data on maternal and/or neonatal complications in pregnancy with macrosomia were included. In pregnancies with macrosomia having a BW > 4000 g, there was an increased risk of the maternal complications: emergency CS, PPH and OASIS, which had OR (95% CI) of 1.98 (1.80-2.18), 2.05 (1.90-2.22) and 1.91 (1.56-2.33), respectively. The corresponding values for pregnancies with BW > 4500 g were: 2.55 (2.33-2.78), 3.15 (2.14-4.63) and 2.56 (1.97-3.32). Similarly, in pregnancies with a BW > 4000 g, there was an increased risk of the neonatal complications: shoulder dystocia, OBPI and birth fractures, which had OR (95% CI) of 9.54 (6.76-13.46), 11.03 (7.06-17.23) and 6.43 (3.67-11.28), respectively. The corresponding values for pregnancies with a BW > 4500 g were: 15.64 (11.31-21.64), 19.87 (12.19-32.40) and 8.16 (2.75-24.23).
CONCLUSION
Macrosomia is associated with serious maternal and neonatal adverse outcomes. This study provides accurate estimates of these risks, which can be used for decisions on pregnancy management. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
Topics: Adult; Cesarean Section; Dystocia; Female; Fetal Macrosomia; Humans; Infant, Newborn; Infant, Newborn, Diseases; Postpartum Hemorrhage; Pregnancy; Pregnancy Complications; Retrospective Studies
PubMed: 30938004
DOI: 10.1002/uog.20279 -
BMJ (Clinical Research Ed.) Sep 2016To assess the association between maternal glucose concentrations and adverse perinatal outcomes in women without gestational or existing diabetes and to determine... (Meta-Analysis)
Meta-Analysis Review
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.
Topics: Birth Weight; Diabetes, Gestational; Dystocia; Evidence-Based Medicine; Female; Fetal Macrosomia; Glucose Tolerance Test; Humans; Hyperglycemia; Infant, Newborn; Pregnancy; Pregnancy Outcome; Premature Birth; Randomized Controlled Trials as Topic; Risk Factors
PubMed: 27624087
DOI: 10.1136/bmj.i4694 -
The Cochrane Database of Systematic... May 2018Water immersion during labour and birth is increasingly popular and is becoming widely accepted across many countries, and particularly in midwifery-led care settings.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Water immersion during labour and birth is increasingly popular and is becoming widely accepted across many countries, and particularly in midwifery-led care settings. However, there are concerns around neonatal water inhalation, increased requirement for admission to neonatal intensive care unit (NICU), maternal and/or neonatal infection, and obstetric anal sphincter injuries (OASIS). This is an update of a review last published in 2011.
OBJECTIVES
To assess the effects of water immersion during labour and/or birth (first, second and third stage of labour) on women and their infants.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (18 July 2017), and reference lists of retrieved trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing water immersion with no immersion, or other non-pharmacological forms of pain management during labour and/or birth in healthy low-risk women at term gestation with a singleton fetus. Quasi-RCTs and cluster-RCTs were eligible for inclusion but none were identified. Cross-over trials were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two review authors assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
This review includes 15 trials conducted between 1990 and 2015 (3663 women): eight involved water immersion during the first stage of labour; two during the second stage only; four during the first and second stages of labour, and one comparing early versus late immersion during the first stage of labour. No trials evaluated different baths/pools, or third-stage labour management. All trials were undertaken in a hospital labour ward setting, with a varying degree of medical intervention considered as routine practice. No study was carried out in a midwifery-led care setting. Most trial authors did not specify the parity of women. Trials were subject to varying degrees of bias: the intervention could not be blinded and there was a lack of information about randomisation, and whether analyses were undertaken by intention-to-treat.Immersion in water versus no immersion (first stage of labour)There is probably little or no difference in spontaneous vaginal birth between immersion and no immersion (82% versus 83%; risk ratio (RR) 1.01, 95% confidence interval (CI) 0.97 to 1.04; 6 trials; 2559 women; moderate-quality evidence); instrumental vaginal birth (14% versus 12%; RR 0.86, 95% CI 0.70 to 1.05; 6 trials; 2559 women; low-quality evidence); and caesarean section (4% versus 5%; RR 1.27, 95% CI 0.91 to 1.79; 7 trials; 2652 women; low-quality evidence). There is insufficient evidence to determine the effect of immersion on estimated blood loss (mean difference (MD) -14.33 mL, 95% CI -63.03 to 34.37; 2 trials; 153 women; very low-quality evidence) and third- or fourth-degree tears (3% versus 3%; RR 1.36, 95% CI 0.85 to 2.18; 4 trials; 2341 women; moderate-quality evidence). There was a small reduction in the risk of using regional analgesia for women allocated to water immersion from 43% to 39% (RR 0.91, 95% CI 0.83 to 0.99; 5 trials; 2439 women; moderate-quality evidence). Perinatal deaths were not reported, and there is insufficient evidence to determine the impact on neonatal intensive care unit (NICU) admissions (6% versus 8%; average RR 1.30, 95% CI 0.42 to 3.97; 2 trials; 1511 infants; I² = 36%; low-quality evidence), or on neonatal infection rates (1% versus 1%; RR 2.00, 95% CI 0.50 to 7.94; 5 trials; 1295 infants; very low-quality evidence).Immersion in water versus no immersion (second stage of labour)There were no clear differences between groups for spontaneous vaginal birth (97% versus 99%; RR 1.02, 95% CI 0.96 to 1.08; 120 women; 1 trial; low-quality evidence); instrumental vaginal birth (2% versus 2%; RR 1.00, 95% CI 0.06 to 15.62; 1 trial; 120 women; very low-quality evidence); caesarean section (2% versus 1%; RR 0.33, 95% CI 0.01 to 8.02; 1 trial; 120 women; very low-quality evidence), and NICU admissions (11% versus 9%; RR 0.78, 95% CI 0.38 to 1.59; 2 trials; 291 women; very low-quality evidence). Use of regional analgesia was not relevant to the second stage of labour. Third- or fourth-degree tears, and estimated blood loss were not reported in either trial. No trial reported neonatal infection but did report neonatal temperature less than 36.2°C at birth (9% versus 9%; RR 0.98, 95% CI 0.30 to 3.20; 1 trial; 109 infants; very low-quality evidence), greater than 37.5°C at birth (6% versus 15%; RR 2.62, 95% CI 0.73 to 9.35; 1 trial; 109 infants; very low-quality evidence), and fever reported in first week (5% versus 2%; RR 0.53, 95% CI 0.10 to 2.82; 1 trial; 171 infants; very low-quality evidence), with no clear effect between groups being observed. One perinatal death occurred in the immersion group in one trial (RR 3.00, 95% CI 0.12 to 72.20; 1 trial; 120 infants; very low-quality evidence). The infant was born to a mother with HIV and the cause of death was deemed to be intrauterine infection.There is no evidence of increased adverse effects to the baby or woman from either the first or second stage of labour.Only one trial (200 women) compared early and late entry into the water and there were insufficient data to show any clear differences.
AUTHORS' CONCLUSIONS
In healthy women at low risk of complications there is moderate to low-quality evidence that water immersion during the first stage of labour probably has little effect on mode of birth or perineal trauma, but may reduce the use of regional analgesia. The evidence for immersion during the second stage of labour is limited and does not show clear differences on maternal or neonatal outcomes intensive care. There is no evidence of increased adverse effects to the fetus/neonate or woman from labouring or giving birth in water. Available evidence is limited by clinical variability and heterogeneity across trials, and no trial has been conducted in a midwifery-led setting.
Topics: Analgesia, Obstetrical; Female; Humans; Immersion; Infant, Newborn; Infant, Newborn, Diseases; Infections; Intensive Care Units, Neonatal; Labor Stage, First; Labor Stage, Second; Natural Childbirth; Perineum; Pregnancy; Randomized Controlled Trials as Topic; Water
PubMed: 29768662
DOI: 10.1002/14651858.CD000111.pub4 -
The Cochrane Database of Systematic... May 2017For centuries, there has been controversy around whether being upright (sitting, birthing stools, chairs, squatting, kneeling) or lying down (lateral (Sim's) position,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
For centuries, there has been controversy around whether being upright (sitting, birthing stools, chairs, squatting, kneeling) or lying down (lateral (Sim's) position, semi-recumbent, lithotomy position, Trendelenburg's position) have advantages for women giving birth to their babies. This is an update of a review previously published in 2012, 2004 and 1999.
OBJECTIVES
To determine the possible benefits and risks of the use of different birth positions during the second stage of labour without epidural anaesthesia, on maternal, fetal, neonatal and caregiver outcomes.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (30 November 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised, quasi-randomised or cluster-randomised controlled trials of any upright position assumed by pregnant women during the second stage of labour compared with supine or lithotomy positions. Secondary comparisons include comparison of different upright positions and the supine position. Trials in abstract form were included.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and assessed trial quality. At least two review authors extracted the data. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS
Results should be interpreted with caution because risk of bias of the included trials was variable. We included eleven new trials for this update; there are now 32 included studies, and one trial is ongoing. Thirty trials involving 9015 women contributed to the analysis. Comparisons include any upright position, birth or squat stool, birth cushion, and birth chair versus supine positions.In all women studied (primigravid and multigravid), when compared with supine positions, the upright position was associated with a reduction in duration of second stage in the upright group (MD -6.16 minutes, 95% CI -9.74 to -2.59 minutes; 19 trials; 5811 women; P = 0.0007; random-effects; I² = 91%; very low-quality evidence); however, this result should be interpreted with caution due to large differences in size and direction of effect in individual studies. Upright positions were also associated with no clear difference in the rates of caesarean section (RR 1.22, 95% CI 0.81 to 1.81; 16 trials; 5439 women; low-quality evidence), a reduction in assisted deliveries (RR 0.75, 95% CI 0.66 to 0.86; 21 trials; 6481 women; moderate-quality evidence), a reduction in episiotomies (average RR 0.75, 95% CI 0.61 to 0.92; 17 trials; 6148 women; random-effects; I² = 88%), a possible increase in second degree perineal tears (RR 1.20, 95% CI 1.00 to 1.44; 18 trials; 6715 women; I² = 43%; low-quality evidence), no clear difference in the number of third or fourth degree perineal tears (RR 0.72, 95% CI 0.32 to 1.65; 6 trials; 1840 women; very low-quality evidence), increased estimated blood loss greater than 500 mL (RR 1.48, 95% CI 1.10 to 1.98; 15 trials; 5615 women; I² = 33%; moderate-quality evidence), fewer abnormal fetal heart rate patterns (RR 0.46, 95% CI 0.22 to 0.93; 2 trials; 617 women), no clear difference in the number of babies admitted to neonatal intensive care (RR 0.79, 95% CI 0.51 to 1.21; 4 trials; 2565 infants; low-quality evidence). On sensitivity analysis excluding trials with high risk of bias, these findings were unchanged except that there was no longer a clear difference in duration of second stage of labour (MD -4.34, 95% CI -9.00 to 0.32; 21 trials; 2499 women; I² = 85%).The main reasons for downgrading of GRADE assessment was that several studies had design limitations (inadequate randomisation and allocation concealment) with high heterogeneity and wide CIs.
AUTHORS' CONCLUSIONS
The findings of this review suggest several possible benefits for upright posture in women without epidural anaesthesia, such as a very small reduction in the duration of second stage of labour (mainly from the primigravid group), reduction in episiotomy rates and assisted deliveries. However, there is an increased risk blood loss greater than 500 mL and there may be an increased risk of second degree tears, though we cannot be certain of this. In view of the variable risk of bias of the trials reviewed, further trials using well-designed protocols are needed to ascertain the true benefits and risks of various birth positions.
Topics: Anesthesia, Epidural; Cesarean Section; Delivery, Obstetric; Episiotomy; Female; Hemorrhage; Humans; Labor Stage, Second; Patient Positioning; Perineum; Pregnancy; Randomized Controlled Trials as Topic; Supine Position; Time Factors; Uterine Hemorrhage
PubMed: 28539008
DOI: 10.1002/14651858.CD002006.pub4 -
The Cochrane Database of Systematic... Jan 2009Episiotomy is done to prevent severe perineal tears, but its routine use has been questioned. The relative effects of midline compared with midlateral episiotomy are... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Episiotomy is done to prevent severe perineal tears, but its routine use has been questioned. The relative effects of midline compared with midlateral episiotomy are unclear.
OBJECTIVES
The objective of this review was to assess the effects of restrictive use of episiotomy compared with routine episiotomy during vaginal birth.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2008).
SELECTION CRITERIA
Randomized trials comparing restrictive use of episiotomy with routine use of episiotomy; restrictive use of mediolateral episiotomy versus routine mediolateral episiotomy; restrictive use of midline episiotomy versus routine midline episiotomy; and use of midline episiotomy versus mediolateral episiotomy.
DATA COLLECTION AND ANALYSIS
The two review authors independently assessed trial quality and extracted the data.
MAIN RESULTS
We included eight studies (5541 women). In the routine episiotomy group, 75.15% (2035/2708) of women had episiotomies, while the rate in the restrictive episiotomy group was 28.40% (776/2733). Compared with routine use, restrictive episiotomy resulted in less severe perineal trauma (relative risk (RR) 0.67, 95% confidence interval (CI) 0.49 to 0.91), less suturing (RR 0.71, 95% CI 0.61 to 0.81) and fewer healing complications (RR 0.69, 95% CI 0.56 to 0.85). Restrictive episiotomy was associated with more anterior perineal trauma (RR 1.84, 95% CI 1.61 to 2.10). There was no difference in severe vaginal/perineal trauma (RR 0.92, 95% CI 0.72 to 1.18); dyspareunia (RR 1.02, 95% CI 0.90 to 1.16); urinary incontinence (RR 0.98, 95% CI 0.79 to 1.20) or several pain measures. Results for restrictive versus routine mediolateral versus midline episiotomy were similar to the overall comparison.
AUTHORS' CONCLUSIONS
Restrictive episiotomy policies appear to have a number of benefits compared to policies based on routine episiotomy. There is less posterior perineal trauma, less suturing and fewer complications, no difference for most pain measures and severe vaginal or perineal trauma, but there was an increased risk of anterior perineal trauma with restrictive episiotomy.
Topics: Episiotomy; Female; Humans; Parturition; Perineum; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 19160176
DOI: 10.1002/14651858.CD000081.pub2 -
The Cochrane Database of Systematic... Feb 2018Newborn admission temperature is a strong predictor of outcomes across all gestations. Hypothermia immediately after birth remains a worldwide issue and, if prolonged,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Newborn admission temperature is a strong predictor of outcomes across all gestations. Hypothermia immediately after birth remains a worldwide issue and, if prolonged, is associated with harm. Keeping preterm infants warm is difficult even when recommended routine thermal care guidelines are followed in the delivery room.
OBJECTIVES
To assess the efficacy and safety of interventions designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room, compared with routine thermal care or any other single/combination of intervention(s) also designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room.
SEARCH METHODS
We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 5), MEDLINE via PubMed (1966 to 30 June 2016), Embase (1980 to 30 June 2016), and CINAHL (1982 to 30 June 2016). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.
SELECTION CRITERIA
Trials using randomised or quasi-randomised allocations to test interventions designed to prevent hypothermia (apart from 'routine' thermal care) applied within 10 minutes after birth in the delivery room for infants at < 37 weeks' gestation and/or birth weight ≤ 2500 grams.
DATA COLLECTION AND ANALYSIS
We used Cochrane Neonatal methods when performing data collection and analysis.
MAIN RESULTS
Twenty-five studies across 15 comparison groups met the inclusion criteria, categorised as: barriers to heat loss (18 studies); external heat sources (three studies); and combinations of interventions (four studies).Barriers to heat loss Plastic wrap or bag versus routine carePlastic wraps improved core body temperature on admission to the neonatal intensive care unit (NICU) or up to two hours after birth (mean difference (MD) 0.58°C, 95% confidence interval (CI) 0.50 to 0.66; 13 studies; 1633 infants), and fewer infants had hypothermia on admission to the NICU or up to two hours after birth (typical risk ratio (RR) 0.67, 95% CI 0.62 to 0.72; typical risk reduction (RD) -0.25, 95% CI -0.29 to -0.20; number needed to treat for an additional beneficial outcome (NNTB) 4, 95% CI 4 to 5; 10 studies; 1417 infants). Risk of hyperthermia on admission to the NICU or up to two hours after birth was increased in infants in the wrapped group (typical RR 3.91, 95% CI 2.05 to 7.44; typical RD 0.04, 95% CI 0.02 to 0.06; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 17 to 50; 12 studies; 1523 infants), but overall, fewer infants receiving plastic wrap were outside the normothermic range (typical RR 0.75, 95% CI 0.69 to 0.81; typical RD -0.20, 95% CI -0.26 to -0.15; NNTH 5, 95% CI 4 to 7; five studies; 1048 infants).Evidence was insufficient to suggest that plastic wraps or bags significantly reduce risk of death during hospital stay or other major morbidities, with the exception of reducing risk of pulmonary haemorrhage.Evidence of practices regarding permutations on this general approach is still emerging and has been based on the findings of only one or two small studies.External heat sourcesEvidence is emerging on the efficacy of external heat sources, including skin-to-skin care (SSC) versus routine care (one study; 31 infants) and thermal mattress versus routine care (two studies; 126 infants).SSC was shown to be effective in reducing risk of hypothermia when compared with conventional incubator care for infants with birth weight ≥ 1200 and ≤ 2199 grams (RR 0.09, 95% CI 0.01 to 0.64; RD -0.56, 95% CI -0.84 to -0.27; NNTB 2, 95% CI 1 to 4). Thermal (transwarmer) mattress significantly kept infants ≤ 1500 grams warmer (MD 0.65°C, 95% CI 0.36 to 0.94) and reduced the incidence of hypothermia on admission to the NICU, with no significant difference in hyperthermia risk.Combinations of interventionsTwo studies (77 infants) compared thermal mattresses versus plastic wraps or bags for infants at ≤ 28 weeks' gestation. Investigators reported no significant differences in core body temperature nor in the incidence of hypothermia, hyperthermia, or core body temperature outside the normothermic range on admission to the NICU.Two additional studies (119 infants) compared plastic bags and thermal mattresses versus plastic bags alone for infants at < 31 weeks' gestation. Meta-analysis of these two studies showed improvement in core body temperature on admission to the NICU or up to two hours after birth, but an increase in hyperthermia. Data show no significant difference in the risk of having a core body temperature outside the normothermic range on admission to the NICU nor in the risk of other reported morbidities.
AUTHORS' CONCLUSIONS
Evidence of moderate quality shows that use of plastic wraps or bags compared with routine care led to higher temperatures on admission to NICUs with less hypothermia, particularly for extremely preterm infants. Thermal mattresses and SSC also reduced hypothermia risk when compared with routine care, but findings are based on two or fewer small studies. Caution must be taken to avoid iatrogenic hyperthermia, particularly when multiple interventions are used simultaneously. Limited evidence suggests benefit and no evidence of harm for most short-term morbidity outcomes known to be associated with hypothermia, including major brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotising enterocolitis, and nosocomial infection. Many observational studies have shown increased mortality among preterm hypothermic infants compared with those who maintain normothermia, yet evidence is insufficient to suggest that these interventions reduce risk of in-hospital mortality across all comparison groups. Hypothermia may be a marker for illness and poorer outcomes by association rather than by causality. Limitations of this review include small numbers of identified studies; small sample sizes; and variations in methods and definitions used for hypothermia, hyperthermia, normothermia, routine care, and morbidity, along with lack of power to detect effects on morbidity and mortality across most comparison groups. Future studies should: be adequately powered to detect rarer outcomes; apply standardised morbidity definitions; focus on longer-term outcomes, particularly neurodevelopmental outcomes.
Topics: Humans; Hypothermia; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Perinatal Care; Randomized Controlled Trials as Topic
PubMed: 29431872
DOI: 10.1002/14651858.CD004210.pub5 -
The Cochrane Database of Systematic... Oct 2020Endometriosis is associated with pain and infertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Endometriosis is associated with pain and infertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy.
OBJECTIVES
To assess the effectiveness and safety of laparoscopic surgery in the treatment of pain and infertility associated with endometriosis.
SEARCH METHODS
This review has drawn on the search strategy developed by the Cochrane Gynaecology and Fertility Group including searching the Cochrane Gynaecology and Fertility Group's specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, reference lists for relevant trials, and trial registries from inception to April 2020.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) that compared the effectiveness and safety of laparoscopic surgery with any other laparoscopic or robotic intervention, holistic or medical treatment, or diagnostic laparoscopy only.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed selection of studies, assessment of trial quality and extraction of relevant data with disagreements resolved by a third review author. We collected data for the core outcome set for endometriosis. Primary outcomes included overall pain and live birth. We evaluated the quality of evidence using GRADE methods.
MAIN RESULTS
We included 14 RCTs. The studies randomised 1563 women with endometriosis. Four RCTs compared laparoscopic ablation or excision with diagnostic laparoscopy only. Two RCTs compared laparoscopic excision with diagnostic laparoscopy only. One RCT compared laparoscopic ablation or excision with laparoscopic ablation or excision and uterine suspension. Two RCTs compared laparoscopic ablation and uterine nerve transection with diagnostic laparoscopy only. One RCT compared laparoscopic ablation with diagnostic laparoscopy and gonadotropin-releasing hormone (GnRH) analogues. Two RCTs compared laparoscopic ablation with laparoscopic excision. One RCT compared laparoscopic ablation or excision with helium thermal coagulator with laparoscopic ablation or excision with electrodiathermy. One RCT compared conservative laparoscopic surgery with laparoscopic colorectal resection of deep endometriosis infiltrating the rectum. Common limitations in the primary studies included lack of clearly described blinding, failure to fully describe methods of randomisation and allocation concealment, and poor reporting of outcome data. Laparoscopic treatment versus diagnostic laparoscopy We are uncertain of the effect of laparoscopic treatment on overall pain scores compared to diagnostic laparoscopy only at six months (mean difference (MD) 0.90, 95% confidence interval (CI) 0.31 to 1.49; 1 RCT, 16 participants; very low quality evidence) and at 12 months (MD 1.65, 95% CI 1.11 to 2.19; 1 RCT, 16 participants; very low quality evidence), where a positive value means pain relief (the higher the score, the more pain relief) and a negative value reflects pain increase (the lower the score, the worse the increase in pain). No studies looked at live birth. We are uncertain of the effect of laparoscopic treatment on quality of life compared to diagnostic laparoscopy only: EuroQol-5D index summary at six months (MD 0.03, 95% CI -0.12 to 0.18; 1 RCT, 39 participants; low quality evidence), 12-item Short Form (SF-12) mental health component (MD 2.30, 95% CI -4.50 to 9.10; 1 RCT, 39 participants; low quality evidence) and SF-12 physical health component (MD 2.70, 95% CI -2.90 to 8.30; 1 RCT, 39 participants; low quality evidence). Laparoscopic treatment probably improves viable intrauterine pregnancy rate compared to diagnostic laparoscopy only (odds ratio (OR) 1.89, 95% CI 1.25 to 2.86; 3 RCTs, 528 participants; I = 0%; moderate quality evidence). We are uncertain of the effect of laparoscopic treatment compared to diagnostic laparoscopy only on ectopic pregnancy (MD 1.18, 95% CI 0.10 to 13.48; 1 RCT, 100 participants; low quality evidence) and miscarriage (MD 0.94, 95% CI 0.35 to 2.54; 2 RCTs, 112 participants; low quality evidence). There was limited reporting of adverse events. No conversions to laparotomy were reported in both groups (1 RCT, 341 participants). Laparoscopic ablation and uterine nerve transection versus diagnostic laparoscopy We are uncertain of the effect of laparoscopic ablation and uterine nerve transection on adverse events (more specifically vascular injury) compared to diagnostic laparoscopy only (OR 0.33, 95% CI 0.01 to 8.32; 1 RCT, 141 participants; low quality evidence). No studies looked at overall pain scores (at six and 12 months), live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage. Laparoscopic ablation versus laparoscopic excision There was insufficient evidence to determine whether there was a difference in overall pain, measured at 12 months, for laparoscopic ablation compared with laparoscopic excision (MD 0.00, 95% CI -1.22 to 1.22; 1 RCT, 103 participants; very low quality evidence). No studies looked at overall pain scores at six months, live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy, miscarriage and adverse events. Helium thermal coagulator versus electrodiathermy We are uncertain whether helium thermal coagulator compared to electrodiathermy improves quality of life using the 30-item Endometriosis Health Profile (EHP-30) at nine months, when considering the components: pain (MD 6.68, 95% CI -3.07 to 16.43; 1 RCT, 119 participants; very low quality evidence), control and powerlessness (MD 4.79, 95% CI -6.92 to 16.50; 1 RCT, 119 participants; very low quality evidence), emotional well-being (MD 6.17, 95% CI -3.95 to 16.29; 1 RCT, 119 participants; very low quality evidence) and social support (MD 5.62, 95% CI -6.21 to 17.45; 1 RCT, 119 participants; very low quality evidence). Adverse events were not estimable. No studies looked at overall pain scores (at six and 12 months), live birth, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage.
AUTHORS' CONCLUSIONS
Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. No data were reported on live birth. There is moderate quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only. No studies were found that looked at live birth for any of the comparisons. Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety.
Topics: Antineoplastic Agents, Hormonal; Denervation; Electrocoagulation; Endometriosis; Female; Goserelin; Helium; Humans; Infertility, Female; Laparoscopy; Pelvic Pain; Pregnancy; Pregnancy Rate; Randomized Controlled Trials as Topic; Uterus
PubMed: 33095458
DOI: 10.1002/14651858.CD011031.pub3 -
American Journal of Perinatology Aug 2017Risk factors for placental abruption have changed, but there has not been an updated systematic review investigating outcomes. We searched PubMed, EMBASE, Web of... (Review)
Review
Risk factors for placental abruption have changed, but there has not been an updated systematic review investigating outcomes. We searched PubMed, EMBASE, Web of Science, SCOPUS, and CINAHL for publications from January 1, 2005 through December 31, 2016. We reviewed English-language publications reporting estimated incidence and/or risk factors for maternal, labor, delivery, and perinatal outcomes associated with abruption. We excluded case studies, conference abstracts, and studies that lacked a referent/comparison group or did not clearly characterize placental abruption. A total of 123 studies were included. Abruption was associated with elevated risk of cesarean delivery, postpartum hemorrhage and transfusion, preterm birth, intrauterine growth restriction or low birth weight, perinatal mortality, and cerebral palsy. Additional maternal outcomes included relaparotomy, hysterectomy, sepsis, amniotic fluid embolism, venous thromboembolism, acute kidney injury, and maternal intensive care unit admission. Additional perinatal outcomes included acidosis, encephalopathy, severe respiratory disorders, necrotizing enterocolitis, acute kidney injury, need for resuscitation, chronic lung disease, infant death, and epilepsy. Few studies examined outcomes beyond the initial birth period, but there is evidence that both mother and child are at risk of additional adverse outcomes. There was also considerable variation in, or absence of, the reporting of abruption definitions.
Topics: Abruptio Placentae; Asphyxia Neonatorum; Blood Transfusion; Cerebral Palsy; Cesarean Section; Female; Fetal Growth Retardation; Humans; Hypoxia, Brain; Infant, Low Birth Weight; Infant, Newborn; Maternal Mortality; Perinatal Mortality; Postpartum Hemorrhage; Pregnancy; Premature Birth; Recurrence; Stillbirth
PubMed: 28329897
DOI: 10.1055/s-0037-1599149 -
JAMA Jan 2020The tort liability system is intended to serve 3 functions: compensate patients who sustain injury from negligence, provide corrective justice, and deter negligence....
IMPORTANCE
The tort liability system is intended to serve 3 functions: compensate patients who sustain injury from negligence, provide corrective justice, and deter negligence. Deterrence, in theory, occurs because clinicians know that they may experience adverse consequences if they negligently injure patients.
OBJECTIVE
To review empirical findings regarding the association between malpractice liability risk (ie, the extent to which clinicians face the threat of being sued and having to pay damages) and health care quality and safety.
DATA SOURCES AND STUDY SELECTION
Systematic search of multiple databases for studies published between January 1, 1990, and November 25, 2019, examining the relationship between malpractice liability risk measures and health outcomes or structural and process indicators of health care quality.
DATA EXTRACTION AND SYNTHESIS
Information on the exposure and outcome measures, results, and acknowledged limitations was extracted by 2 reviewers. Meta-analytic pooling was not possible due to variations in study designs; therefore, studies were summarized descriptively and assessed qualitatively.
MAIN OUTCOMES AND MEASURES
Associations between malpractice risk measures and health care quality and safety outcomes. Exposure measures included physicians' malpractice insurance premiums, state tort reforms, frequency of paid claims, average claim payment, physicians' claims history, total malpractice payments, jury awards, the presence of an immunity from malpractice liability, the Centers for Medicare & Medicaid Services' Medicare malpractice geographic practice cost index, and composite measures combining these measures. Outcome measures included patient mortality; hospital readmissions, avoidable admissions, and prolonged length of stay; receipt of cancer screening; Agency for Healthcare Research and Quality patient safety indicators and other measures of adverse events; measures of hospital and nursing home quality; and patient satisfaction.
RESULTS
Thirty-seven studies were included; 28 examined hospital care only and 16 focused on obstetrical care. Among obstetrical care studies, 9 found no significant association between liability risk and outcomes (such as Apgar score and birth injuries) and 7 found limited evidence for an association. Among 20 studies of patient mortality in nonobstetrical care settings, 15 found no evidence of an association with liability risk and 5 found limited evidence. Among 7 studies that examined hospital readmissions and avoidable initial hospitalizations, none found evidence of an association between liability risk and outcomes. Among 12 studies of other measures (eg, patient safety indicators, process-of-care quality measures, patient satisfaction), 7 found no association between liability risk and these outcomes and 5 identified significant associations in some analyses.
CONCLUSIONS AND RELEVANCE
In this systematic review, most studies found no association between measures of malpractice liability risk and health care quality and outcomes. Although gaps in the evidence remain, the available findings suggested that greater tort liability, at least in its current form, was not associated with improved quality of care.
Topics: Humans; Insurance, Liability; Liability, Legal; Malpractice; Obstetrics; Outcome Assessment, Health Care; Postoperative Complications; Quality of Health Care
PubMed: 31990319
DOI: 10.1001/jama.2019.21411 -
The Cochrane Database of Systematic... Jul 2022Communication about end of life (EoL) and EoL care is critically important for providing quality care as people approach death. Such communication is often complex and... (Review)
Review
BACKGROUND
Communication about end of life (EoL) and EoL care is critically important for providing quality care as people approach death. Such communication is often complex and involves many people (patients, family members, carers, health professionals). How best to communicate with people in the period approaching death is not known, but is an important question for quality of care at EoL worldwide. This review fills a gap in the evidence on interpersonal communication (between people and health professionals) in the last year of life, focusing on interventions to improve interpersonal communication and patient, family member and carer outcomes.
OBJECTIVES
To assess the effects of interventions designed to improve verbal interpersonal communication about EoL care between health practitioners and people affected by EoL.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL from inception to July 2018, without language or date restrictions. We contacted authors of included studies and experts and searched reference lists to identify relevant papers. We searched grey literature sources, conference proceedings, and clinical trials registries in September 2019. Database searches were re-run in June 2021 and potentially relevant studies listed as awaiting classification or ongoing.
SELECTION CRITERIA
This review assessed the effects of interventions, evaluated in randomised and quasi-randomised trials, intended to enhance interpersonal communication about EoL care between patients expected to die within 12 months, their family members and carers, and health practitioners involved in their care. Patients of any age from birth, in any setting or care context (e.g. acute catastrophic injury, chronic illness), and all health professionals involved in their care were eligible. All communication interventions were eligible, as long as they included interpersonal interaction(s) between patients and family members or carers and health professionals. Interventions could be simple or complex, with one or more communication aims (e.g. to inform, skill, engage, support). Effects were sought on outcomes for patients, family and carers, health professionals and health systems, including adverse (unintended) effects. To ensure this review's focus was maintained on interpersonal communication in the last 12 months of life, we excluded studies that addressed specific decisions, shared or otherwise, and the tools involved in such decision-making. We also excluded studies focused on advance care planning (ACP) reporting ACP uptake or completion as the primary outcome. Finally, we excluded studies of communication skills training for health professionals unless patient outcomes were reported as primary outcomes.
DATA COLLECTION AND ANALYSIS
Standard Cochrane methods were used, including dual review author study selection, data extraction and quality assessment of the included studies.
MAIN RESULTS
Eight trials were included. All assessed intervention effects compared with usual care. Certainty of the evidence was low or very low. All outcomes were downgraded for indirectness based on the review's purpose, and many were downgraded for imprecision and/or inconsistency. Certainty was not commonly downgraded for methodological limitations. A summary of the review's findings is as follows. Knowledge and understanding (four studies, low-certainty evidence; one study without usable data): interventions to improve communication (e.g. question prompt list, with or without patient and physician training) may have little or no effect on knowledge of illness and prognosis, or information needs and preferences, although studies were small and measures used varied across trials. Evaluation of the communication (six studies measuring several constructs (communication quality, patient-centredness, involvement preferences, doctor-patient relationship, satisfaction with consultation), most low-certainty evidence): across constructs there may be minimal or no effects of interventions to improve EoL communication, and there is uncertainty about effects of interventions such as a patient-specific feedback sheet on quality of communication. Discussions of EoL or EoL care (six studies measuring selected outcomes, low- or very low-certainty evidence): a family conference intervention may increase duration of EoL discussions in an intensive care unit (ICU) setting, while use of a structured serious illness conversation guide may lead to earlier discussions of EoL and EoL care (each assessed by one study). We are uncertain about effects on occurrence of discussions and question asking in consultations, and there may be little or no effect on content of communication in consultations. Adverse outcomes or unintended effects (limited evidence): there is insufficient evidence to determine whether there are adverse outcomes associated with communication interventions (e.g. question prompt list, family conference, structured discussions) for EoL and EoL care. Patient and/or carer anxiety was reported by three studies, but judged as confounded. No other unintended consequences, or worsening of desired outcomes, were reported. Patient/carer quality of life (four studies, low-certainty evidence; two without useable data): interventions to improve communication may have little or no effect on quality of life. Health practitioner outcomes (three studies, low-certainty evidence; two without usable data): interventions to improve communication may have little or no effect on health practitioner outcomes (satisfaction with communication during consultation; one study); effects on other outcomes (knowledge, preparedness to communicate) are unknown. Health systems impacts: communication interventions (e.g. structured EoL conversations) may have little or no effect on carer or clinician ratings of quality of EoL care (satisfaction with care, symptom management, comfort assessment, quality of care) (three studies, low-certainty evidence), or on patients' self-rated care and illness, or numbers of care goals met (one study, low-certainty evidence). Communication interventions (e.g. question prompt list alone or with nurse-led communication skills training) may slightly increase mean consultation length (two studies), but other health service impacts (e.g. hospital admissions) are unclear.
AUTHORS' CONCLUSIONS
Findings of this review are inconclusive for practice. Future research might contribute meaningfully by seeking to fill gaps for populations not yet studied in trials; and to develop responsive outcome measures with which to better assess the effects of communication on the range of people involved in EoL communication episodes. Mixed methods and/or qualitative research may contribute usefully to better understand the complex interplay between different parties involved in communication, and to inform development of more effective interventions and appropriate outcome measures. Co-design of such interventions and outcomes, involving the full range of people affected by EoL communication and care, should be a key underpinning principle for future research in this area.
Topics: Anxiety; Communication; Humans; Physician-Patient Relations; Quality of Life; Randomized Controlled Trials as Topic; Terminal Care
PubMed: 35802350
DOI: 10.1002/14651858.CD013116.pub2