ABSTRACT
BACKGROUND: Medical students face challenges to their mental wellbeing and have a high prevalence of mental health problems. During training, they are expected to develop strategies for dealing with stress. This study investigated factors medical students perceived as draining and replenishing during COVID-19, using the 'coping reservoir' model of wellbeing. METHODS: In synchronous interactive pre-recorded webinars, 78 fourth-year medical students in the UK responded to reflective prompts. Participants wrote open-text comments on a Padlet site. Responses were analysed using reflexive thematic analysis. RESULTS: Analysis identified five themes. COVID-19 exacerbated academic pressures, while reducing the strategies available to cope with stress. Relational connections with family and friends were affected by the pandemic, leading to isolation and reliance on housemates for informal support. Relationships with patients were adversely affected by masks and telephone consultations, however attending placement was protective for some students' wellbeing. Experiences of formal support were generally positive, but some students experienced attitudinal and practical barriers. CONCLUSIONS: This study used a novel methodology to elicit medical students' reflections on their mental wellbeing during COVID-19. Our findings reinforce and extend the 'coping reservoir' model, increasing our understanding of factors that contribute to resilience or burnout. Many stressors that medical students typically face were exacerbated during COVID-19, and their access to coping strategies and support were restricted. The changes to relationships with family, friends, patients, and staff resulted in reduced support and isolation. Recognising the importance of relational connections upon medical students' mental wellbeing can inform future support.
Subject(s)
COVID-19 , Resilience, Psychological , Students, Medical , Humans , Coping Skills , COVID-19/epidemiology , Qualitative ResearchABSTRACT
In 2015, the World Health Assembly adopted a global action plan (GAP) on antimicrobial resistance (AMR). Member states were encouraged to develop their own national action plans (NAPs) in alignment with the GAP. To-date, in systematic assessments of NAPs, the Latin American specific context has not been previously analysed. Here we examined 11 Latin American NAPs published between 2015 and 2021 using content analysis. We focused on two approaches: (1) alignment between the strategic objectives and actions defined in the GAP, and those outlined in the NAPs via a content indicator; and (2) assessment of the NAPs via a governance framework covering 'policy design', 'implementation tools' and 'monitoring and evaluation' areas. We observed a high alignment with the strategic objectives of the GAP; however, the opposite was observed for the corresponding actions. Our results showed that the governance aspects contained within coordination and participation domains were addressed by every Latin American NAP, whereas monitoring and assessment areas, as well as incorporating the environment, would need more attention in subsequent NAPs. Given that AMR is a global health threat and collective efforts across regions are necessary to combat it, our findings can benefit member states by highlighting how to strengthen the AMR strategies in Latin America, while also supporting global policy formulation.
Subject(s)
Anti-Bacterial Agents , Drug Resistance, Bacterial , Humans , Anti-Bacterial Agents/therapeutic use , Latin America , Health Policy , Global HealthABSTRACT
Grasslands (natural, semi-natural and improved) occupy approximately one-third of the terrestrial biosphere and are key for global ecosystem service provision, storing up to 30% of soil organic carbon (SOC). To date, most research on soil carbon (C) sequestration has focused on croplands where the levels of native soil organic matter (SOM) are typically low and significant potential exists to replenish SOM stocks. However, with the renewed push to achieve "net zero" C emissions by 2050, grasslands may offer an additional C store, utilising tools such as biochar. Here, we critically evaluate the potential for biochar as a technology for increasing grassland C stocks, identifying a number of practical, economic, social and legislative challenges that need to be addressed before the widescale adoption of biochar may be achieved. We critically assess the current knowledge within the field of grassland biochar research in the context of ecosystem service provision and provide opinions on the applicability of biochar as an amendment to different types of grassland (improved, semi-improved and unimproved) and the potential effect on ecosystem provision using a range of application techniques in the topsoil and subsoil. We concluded that the key question remains, is it possible for managed grasslands to store more C, without causing a loss in additional ecosystem services? To address this question future research must take a more multidisciplinary and holistic approach when evaluating the potential role of biochar at sequestering C in grasslands to mitigate climate change. Supplementary Information: The online version contains supplementary material available at 10.1007/s42773-023-00232-y.
ABSTRACT
Recent research on the magnetisation of biochar, a carbon-based material that can be used as a sorbent, has opened novel opportunities in the field of environmental remediation, as incorporating magnetic particles into biochar can simplify subsequent separation. This could offer a sustainable circular economy-based solution in two areas of waste management; firstly, pyrolysis of agricultural waste for magnetic biochar synthesis could reduce greenhouse gas emissions derived from traditional agricultural waste processing, such as landfill and incineration, while secondly, application of magnetic biochar to remove excess nitrogen from soils (made possible through magnetic separation) could provide opportunities for this pollutant to be used as a recycled fertiliser. While sorption of pollutants by magnetic biochar has been researched in wastewater, few studies have investigated magnetic biochar use in polluted soils. Nitrogen pollution (e.g. NH4+), stemming from agricultural fertiliser management, is a major environmental and economic issue that could be significantly reduced before losses from soils occur. This review demonstrates that the use of magnetic biochar tailored to NH4+ adsorption has potential to remove (and recycle for reuse) excess nitrogen from soils. Analysis of research into recovery of NH4+ by sorption/desorption, biochar magnetisation and biochar-soil interactions, suggests that this is a promising application, but a more cohesive, interdisciplinary approach is called for to elucidate its feasibility. Furthermore, research shows variable impacts of biochar upon soil chemistry and biology, such as pH and microbial diversity. Considering wide concerns surrounding global biodiversity depletion, a more comprehensive understanding of biochar-soil dynamics is required to protect and support soil ecosystems. Finally, addressing research gaps, such as optimisation and scaling-up of magnetic biochar synthesis, would benefit from systems thinking approaches, ensuring the many complex considerations across science, industry, policy and economics are connected by circular-economy principles.
Subject(s)
Ammonium Compounds , Soil Pollutants , Charcoal , Ecosystem , Magnetic Phenomena , SoilABSTRACT
Serratia marcescens strain BTL07, which has the ability to promote growth and suppress plant diseases, was isolated from the rhizoplane of a chili plant. The draft genome sequence data of the strain will contribute to advancing our understanding of the molecular mechanisms underlying plant growth promotion and tolerance to different stresses.
ABSTRACT
Plant growth-promoting bacteria that are also capable of suppressing plant pathogenic fungi play an important role in sustainable agriculture. There is a critical need for conducting research to discover, characterize and evaluate the efficacy of new strains of such bacteria in controlling highly aggressive plant pathogens. In this study, we isolated endophytic bacteria from medicinal plants of Bangladesh and evaluated their antagonistic capacity against an important phytopathogenic fungus Sclerotinia sclerotiorum. Growth-promoting effects of those isolates on cucumber and rice seedlings were also assessed. Among 16 morphologically distinct isolates, BDR-2, BRtL-2 and BCL-1 significantly inhibited the growth of S. sclerotiorum through induction of characteristic morphological alterations in hyphae and reduction of mycelial dry weight. When cucumber and rice seeds were treated with these endophytic bacteria, seven isolates (BCL-1, BDL-1, BRtL-2, BRtL-3, BDR-1, BDR-2 and BBoS-1) enhanced seed germination, seedling vigor, seedling growth and number of roots per plant at a varying level compared to untreated controls. All isolates produced high levels of indole-3-acetic acid (6 to 63 µg/mL) in vitro. Two most potential isolates, BDR-2 and BRtL-2, were identified as Bacillus amyloliquefaciens and B. subtilis, respectively, based on the 16S rRNA gene sequencing. These results suggest that endophytic Bacillus species from native medicinal plants have great potential for being used as natural plant growth promoter and biopesticides in sustainable crop production.
Subject(s)
Ascomycota/drug effects , Bacillus/physiology , Plants, Medicinal/microbiology , Seeds/growth & development , Bacillus/classification , Bangladesh , Cucumis sativus/growth & development , Cucumis sativus/microbiology , Endophytes/classification , Endophytes/physiology , Oryza/growth & development , Oryza/microbiology , Phylogeny , Plant Diseases/microbiology , Plant Roots/growth & development , Plant Roots/microbiology , RNA, Ribosomal, 16S/genetics , Seeds/microbiology , Sequence Analysis, RNAABSTRACT
The objective of this study was to isolate and characterize antagonistic rhizobacteria from chili against a notorious phytopathogen Phytophthora capsici. Among the 48 bacteria isolated, BTLbbc-02, BTLbbc-03, and BTLbbc-05 were selected based on their inhibitory activity against P. capsici. They were tentatively identified as Burkholderia metallica BTLbbc-02, Burkholderia cepacia BTLbbc-03, and Pseudomonas aeruginosa BTLbbc-05, respectively, based on their 16S rRNA gene sequencing. All inhibited the growth of P. capsici at varying levels by inducing characteristic morphological alterations of P. capsici hyphae. The cell-free culture supernatant of all three isolates impaired motility (up to 100%) and caused lysis (up to 50%) of the halted zoospores. Bioassays revealed that Pseudomonas sp. had higher antagonism and zoospore motility-inhibitory effects against P. capsici compared with two other isolates, Burkholderia spp. and B. metallica, which caused vacuolation in mycelium. All three bacteria suppressed sporangium formation and zoosporogenesis of P. capsici, and improved the seed germination and growth of cucumber. Our findings suggest that epiphytic bacteria, B. metallica, B. cepacia, and P. aeruginosa, could be used as potential biocontrol agents against P. capsici. A further study is required to ensure conformity with the existing regulations for soil, plant, and human health.
Subject(s)
Antibiosis , Burkholderia cepacia/physiology , Phytophthora/physiology , Pseudomonas aeruginosa/physiology , Biological Control Agents/pharmacology , Phytophthora/drug effects , Spores, Fungal/drug effectsABSTRACT
BACKGROUND AND OBJECTIVE: Outpatient parenteral antimicrobial therapy (OPAT) provides numerous benefits but may pose unique risks in children. We aimed to determine rates of OPAT antimicrobial- and intravenous access-related complications and their associations with specific antimicrobials and type of intravenous access in pediatric patients. METHODS: Observational cohort study of patients receiving OPAT from August 2008 to May 2015 cared for by the Infectious Diseases service at a tertiary children's hospital. Primary outcome was antimicrobial discontinuation (AD) because of OPAT-associated complications. Secondary outcomes were unplanned outpatient healthcare visits and readmissions from OPAT-associated complications. RESULTS: Seven hundred and seven intravenous antimicrobials were prescribed in 540 cases. Nondevice-associated musculoskeletal infection was the most common diagnosis (39%). Ceftriaxone (30%), cefazolin (27%) and vancomycin (22%) were the most commonly used antimicrobials. Complications led to AD, ≥1 unplanned outpatient healthcare visit and ≥1 readmission in 23%, 30% and 17% of cases, respectively. Compared with use of ceftriaxone, use of oxacillin was associated with a significantly higher risk of AD because of any antimicrobial-related complication [hazard ratio (HR), 3.3; 95% confidence interval (CI): 1.2-9.7) and because of hepatic transaminitis (HR, 32.8; 95% CI: 4.02-268.2). Subjects treated with intravenous clindamycin (HR, 2.6; 95% CI: 1.1-5.8) and with a peripherally inserted central catheter (HR, 2.6; 95% CI: 1.04-6.3) were more likely to have unplanned outpatient visits. CONCLUSIONS: Use of oxacillin during OPAT was associated with higher rate of AD. Patients treated with clindamycin and those with a peripherally inserted central catheter had higher rates of unplanned outpatient visits. Providers should strongly consider alternative treatment options when possible.
Subject(s)
Anti-Infective Agents/administration & dosage , Injection Site Reaction/epidemiology , Outpatients/statistics & numerical data , Administration, Intravenous , Adolescent , Anti-Infective Agents/adverse effects , Child , Cohort Studies , Female , Hospitals, Pediatric , Humans , Male , Patient Readmission , Retrospective Studies , Withholding Treatment/statistics & numerical dataABSTRACT
BACKGROUND: Self-monitoring of blood glucose (SMBG) is recommended as a key component of the management plan for diabetes therapy during pregnancy. No existing systematic reviews consider the benefits/effectiveness of various techniques of blood glucose monitoring on maternal and infant outcomes among pregnant women with pre-existing diabetes. The effectiveness of the various monitoring techniques is unclear. OBJECTIVES: To compare techniques of blood glucose monitoring and their impact on maternal and infant outcomes among pregnant women with pre-existing diabetes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016), searched reference lists of retrieved studies and contacted trial authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing techniques of blood glucose monitoring including SMBG, continuous glucose monitoring (CGM) or clinic monitoring among pregnant women with pre-existing diabetes mellitus (type 1 or type 2). Trials investigating timing and frequency of monitoring were also included. RCTs using a cluster-randomised design were eligible for inclusion but none were identified. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: This review update includes at total of 10 trials (538) women (468 women with type 1 diabetes and 70 women with type 2 diabetes). The trials took place in Europe and the USA. Five of the 10 included studies were at moderate risk of bias, four studies were at low to moderate risk of bias, and one study was at high risk of bias. The trials are too small to show differences in important outcomes such as macrosomia, preterm birth, miscarriage or death of baby. Almost all the reported GRADE outcomes were assessed as being very low-quality evidence. This was due to design limitations in the studies, wide confidence intervals, small sample sizes, and few events. In addition, there was high heterogeneity for some outcomes.Various methods of glucose monitoring were compared in the trials. Neither pooled analyses nor individual trial analyses showed any clear advantages of one monitoring technique over another for primary and secondary outcomes. Many important outcomes were not reported.1. Self-monitoring versus standard care (two studies, 43 women): there was no clear difference for caesarean section (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.40 to 1.49; one study, 28 women) or glycaemic control (both very low-quality), and not enough evidence to assess perinatal mortality and neonatal mortality and morbidity composite. Hypertensive disorders of pregnancy, large-for-gestational age, neurosensory disability, and preterm birth were not reported in either study.2. Self-monitoring versus hospitalisation (one study, 100 women): there was no clear difference for hypertensive disorders of pregnancy (pre-eclampsia and hypertension) (RR 4.26, 95% CI 0.52 to 35.16; very low-quality: RR 0.43, 95% CI 0.08 to 2.22; very low-quality). There was no clear difference in caesarean section or preterm birth less than 37 weeks' gestation (both very low quality), and the sample size was too small to assess perinatal mortality (very low-quality). Large-for-gestational age, mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.3. Pre-prandial versus post-prandial glucose monitoring (one study, 61 women): there was no clear difference between groups for caesarean section (RR 1.45, 95% CI 0.92 to 2.28; very low-quality), large-for-gestational age (RR 1.16, 95% CI 0.73 to 1.85; very low-quality) or glycaemic control (very low-quality). The results for hypertensive disorders of pregnancy: pre-eclampsia and perinatal mortality are not meaningful because these outcomes were too rare to show differences in a small sample (all very low-quality). The study did not report the outcomes mortality or morbidity composite, neurosensory disability or preterm birth.4. Automated telemedicine monitoring versus conventional system (three studies, 84 women): there was no clear difference for caesarean section (RR 0.96, 95% CI 0.62 to 1.48; one study, 32 women; very low-quality), and mortality or morbidity composite in the one study that reported these outcomes. There were no clear differences for glycaemic control (very low-quality). No studies reported hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), neurosensory disability or preterm birth.5.CGM versus intermittent monitoring (two studies, 225 women): there was no clear difference for pre-eclampsia (RR 1.37, 95% CI 0.52 to 3.59; low-quality), caesarean section (average RR 1.00, 95% CI 0.65 to 1.54; I² = 62%; very low-quality) and large-for-gestational age (average RR 0.89, 95% CI 0.41 to 1.92; I² = 82%; very low-quality). Glycaemic control indicated by mean maternal HbA1c was lower for women in the continuous monitoring group (mean difference (MD) -0.60 %, 95% CI -0.91 to -0.29; one study, 71 women; moderate-quality). There was not enough evidence to assess perinatal mortality and there were no clear differences for preterm birth less than 37 weeks' gestation (low-quality). Mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.6. Constant CGM versus intermittent CGM (one study, 25 women): there was no clear difference between groups for caesarean section (RR 0.77, 95% CI 0.33 to 1.79; very low-quality), glycaemic control (mean blood glucose in the 3rd trimester) (MD -0.14 mmol/L, 95% CI -2.00 to 1.72; very low-quality) or preterm birth less than 37 weeks' gestation (RR 1.08, 95% CI 0.08 to 15.46; very low-quality). Other primary (hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), mortality or morbidity composite, and neurosensory disability) or GRADE outcomes (preterm birth less than 34 weeks' gestation) were not reported. AUTHORS' CONCLUSIONS: This review found no evidence that any glucose monitoring technique is superior to any other technique among pregnant women with pre-existing type 1 or type 2 diabetes. The evidence base for the effectiveness of monitoring techniques is weak and additional evidence from large well-designed randomised trials is required to inform choices of glucose monitoring techniques.
Subject(s)
Blood Glucose Self-Monitoring/methods , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 2/blood , Pregnancy Outcome , Pregnancy in Diabetics/blood , Cesarean Section/statistics & numerical data , Fasting/blood , Female , Glycated Hemoglobin/analysis , Hospitalization , Humans , Infant, Newborn , Perinatal Mortality , Postprandial Period , Pregnancy , Pregnancy Complications, Cardiovascular/epidemiology , Premature Birth/epidemiology , Randomized Controlled Trials as Topic , TelemedicineABSTRACT
BACKGROUND: Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013. OBJECTIVES: To assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy. MAIN RESULTS: Eight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns. Vaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported. Vaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported. Foley catheter versus intravenous oxytocin (one trial, subgroup of 53 women): no clear difference between groups for vaginal delivery not achieved within 24 hours (RR 1.47, 95% CI 0.89 to 2.44, evidence graded low), uterine hyperstimulation with fetal heart rate changes (RR 3.11, 95% CI 0.13 to 73.09, evidence graded low), and caesarean section (RR 0.93, 95% CI 0.45 to 1.92, evidence graded low). There were also no clear differences between groups for the reported secondary outcomes. The following GRADE outcomes were not reported: serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Double-balloon catheter versus vaginal PGE2 (one trial, subgroup of 26 women): no clear difference in caesarean section (RR 0.97, 95% CI 0.41 to 2.32, evidence graded very low). Vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death were not reported. Oral mifepristone versus Foley catheter (one trial, 107 women): no primary/GRADE outcomes were reported. Fewer women induced with mifepristone required oxytocin augmentation (RR 0.54, 95% CI 0.38 to 0.76). There were slightly fewer cases of uterine rupture among women who received mifepristone, however this was not a clear difference between groups (RR 0.29, 95% CI 0.08 to 1.02). No other secondary outcomes were reported. Vaginal isosorbide mononitrate (IMN) versus Foley catheter (one trial, 80 women): fewer women induced with IMN achieved a vaginal delivery within 24 hours (RR 2.62, 95% CI 1.32 to 5.21, evidence graded low). There was no difference between groups in the number of women who had a caesarean section (RR 1.00, 95% CI 0.39 to 2.59, evidence graded very low). More women induced with IMN required oxytocin augmentation (RR 1.65, 95% CI 1.17 to 2.32). There were no clear differences in the other reported secondary outcomes. The following GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. 80 mL versus 30 mL Foley catheter (one trial, 154 women): no clear difference between groups for the primary outcomes: vaginal delivery not achieved within 24 hours (RR 1.05, 95% CI 0.91 to 1.20, evidence graded moderate) and caesarean section (RR 1.05, 95% CI 0.89 to 1.24, evidence graded moderate). However, more women induced using a 30 mL Foley catheter required oxytocin augmentation (RR 0.81, 95% CI 0.66 to 0.98). There were no clear differences between groups for other secondary outcomes reported. Several GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Vaginal PGE2 pessary versus vaginal PGE2 tablet (one trial, 200 women): no difference between groups for caesarean section (RR 1.09, 95% CI 0.74 to 1.60, evidence graded very low), or any of the reported secondary outcomes. Several GRADE outcomes were not reported: vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. AUTHORS' CONCLUSIONS: RCT evidence on methods of induction of labour for women with a prior caesarean section is inadequate, and studies are underpowered to detect clinically relevant differences for many outcomes. Several studies reported few of our prespecified outcomes and reporting of infant outcomes was especially scarce. The GRADE level for quality of evidence was moderate to very low, due to imprecision and study design limitations.High-quality, adequately-powered RCTs would be the best approach to determine the optimal method for induction of labour in women with a prior caesarean birth. However, such trials are unlikely to be undertaken due to the very large numbers needed to investigate the risk of infrequent but serious adverse outcomes (e.g. uterine rupture). Observational studies (cohort studies), including different methods of cervical ripening, may be the best alternative. Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review.
Subject(s)
Labor, Induced/methods , Oxytocics/administration & dosage , Vaginal Birth after Cesarean , Dinoprostone/administration & dosage , Early Termination of Clinical Trials , Female , Humans , Misoprostol/administration & dosage , Oxytocin/administration & dosage , Pregnancy , Randomized Controlled Trials as Topic , Uterine Rupture/etiologyABSTRACT
BACKGROUND: There are rising rates of multiple births worldwide with associated higher rates of complications and more hospital care, often due to prematurity. While there is strong evidence about the risks of not breastfeeding, rates of breastfeeding in women who have given birth to more than one infant are lower than with singleton births. Breastfeeding more than one infant can be more challenging because of difficulties associated with the birth or prematurity. The extra demands on the mother of frequent suckling, coordinating the needs of more than one infant or admission to the neonatal intensive care unit can lead to delayed initiation or early cessation. Additional options such as breast milk expression, the use of donor milk or different methods of supplementary feeding may be considered. Support and education about breastfeeding has been found to improve the duration of any breastfeeding for healthy term infants and their mothers, however evidence is lacking about interventions that are effective to support women with twins or higher order multiples. OBJECTIVES: To assess effectiveness of breastfeeding education and support for women with twins or higher order multiples. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2016), ClinicalTrials.gov (30 June 2016), the WHO International Clinical Trials Registry Platform (ICTRP) (1 July 2016), the excluded studies list from the equivalent Cochrane review of singletons, and reference lists of retrieved studies. SELECTION CRITERIA: Randomised or quasi-randomised trials comparing extra education or support for women with twins or higher order multiples were included. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We planned to assess the quality of evidence using the GRADE approach, but were unable to analyse any data. MAIN RESULTS: We found 10 trials (23 reports) of education and support for breastfeeding that included women with twins or higher order multiples. The quality of evidence was mixed, and the risk of bias was mostly high or unclear. It is difficult to blind women or staff to group allocation for this intervention, so in all studies there was high risk of performance and high or unclear risk of detection bias. Trials recruited 5787 women (this included 512 women interviewed as part of a cluster randomised trial); of these, data were available from two studies for 42 women with twins or higher order multiples. None of the interventions were specifically designed for women with more than one infant, and the outcomes for multiples were not reported separately for each infant. Due to the scarcity of evidence and the format in which data were reported, a narrative description of the data is presented, no analyses are presented in this review, and we were unable to GRADE the evidence.The two trials with data for women with multiple births compared home nurse visits versus usual care (15 women), and telephone peer counselling versus usual care (27 women). The number of women who initiated breastfeeding was reported (all 15 women in one study, 25 out of 27 women in one study). Stopping any breastfeeding before four to six weeks postpartum, stopping exclusive breastfeeding before four to six weeks postpartum, stopping any breastfeeding before six months postpartum andstopping exclusive breastfeeding before six months postpartum were not explicitly reported, and there were insufficient data to draw any meaningful conclusions from survival data. Stopping breast milk expression before four to six weeks postpartum, andstopping breast milk expression before six months postpartum were not reported. Measures ofmaternal satisfaction were reported in one study of 15 women, but there were insufficient data to draw any conclusions; no other secondary outcomes were reported for women with multiple births in either study. No adverse events were reported. AUTHORS' CONCLUSIONS: We found no evidence from randomised controlled trials about the effectiveness of breastfeeding education and support for women with twins or higher order multiples, or the most effective way to provide education and support . There was no evidence about the best way to deliver the intervention, the timing of care, or the best person to deliver the care. There is a need for well-designed, adequately powered studies of interventions designed for women with twins or higher order multiples to find out what types of education and support are effective in helping these mothers to breastfeed their babies.
Subject(s)
Breast Feeding , Mothers/education , Multiple Birth Offspring , Breast Milk Expression , Counseling , Female , House Calls , Humans , Infant , Randomized Controlled Trials as Topic , Telephone , TwinsABSTRACT
The disposal of biosolids poses a major environmental and economic problem. Agricultural use is generally regarded as the best means of disposal. However, its impact on soil ecosystems remains uncertain. Biosolids can improve soil properties by supplying nutrients and increasing organic matter content but there is also a potentially detrimental effect arising from the introduction of heavy metals into soils. To assess the balance between these competing effects on soil health, we investigated soil bacterial and fungal diversity and community structure at a site that has been dedicated to the disposal of sewage sludge for over 100 years. Terminal restriction fragment length polymorphism (T-RFLP) was used to characterize the soil microbial communities. The most important contaminants at the site were Ni, Cu, Zn, Cd, and Pb. Concentrations were highly correlated and Zn concentration was adopted as a good indicator of the overall (historical) biosolids loading. A biosolids loading, equivalent to 700-1000 mg kg-1 Zn appeared to be optimal for maximum bacterial and fungal diversity. This markedly exceeds the maximum soil Zn concentration of 300 mg kg-1permitted under the current UK Sludge (use in agriculture) Regulations. Redundancy analysis (RDA) suggested that the soil microbial communities had been altered in response to the accumulation of trace metals, especially Zn, Cd, and Cu. We believe this is the first time the trade-off between positive and negative effects of long term (>100 years) biosolids disposal on soil microorganisms have been observed in the field situation.
Subject(s)
Sewage , Soil Microbiology , Soil Pollutants/analysis , Agriculture , Biodiversity , Metals, Heavy/analysis , Sewage/chemistry , Trace Elements/analysisABSTRACT
BACKGROUND: Insulin requirements may change during pregnancy, and the optimal treatment for pre-existing diabetes is unclear. There are several insulin regimens (e.g. via syringe, pen) and types of insulin (e.g. fast-acting insulin, human insulin). OBJECTIVES: To assess the effects of different insulin types and different insulin regimens in pregnant women with pre-existing type 1 or type 2 diabetes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 October 2016), ClinicalTrials.gov (17 October 2016), the WHO International Clinical Trials Registry Platform (ICTRP; 17 October 2016), and the reference lists of retrieved studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared different insulin types and regimens in pregnant women with pre-existing diabetes.We had planned to include cluster-RCTs, but none were identified. We excluded quasi-randomised controlled trials and cross-over trials. We included studies published in abstract form and contacted the authors for further details when applicable. Conference abstracts were superseded by full publications. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, conducted data extraction, assessed risk of bias, and checked for accuracy. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: The findings in this review were based on very low-quality evidence, from single, small sample sized trial estimates, with wide confidence intervals (CI), some of which crossed the line of no effect; many of the prespecified outcomes were not reported. Therefore, they should be interpreted with caution. We included five trials that included 554 women and babies (four open-label, multi-centre, two-arm trials; one single centre, four-arm RCT). All five trials were at a high or unclear risk of bias due to lack of blinding, unclear methods of randomisation, and selective reporting of outcomes. Pooling of data from the trials was not possible, as each trial looked at a different comparison.1. One trial (N = 33 women) compared Lispro insulin with regular insulin and provided very low-quality evidence for the outcomes. There were seven episodes of pre-eclampsia in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (risk ratio (RR) 0.68, 95% CI 0.35 to 1.30). There were five caesarean sections in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (RR 0.59, 95% CI 0.25 to 1.39). There were no cases of fetal anomaly in the Lispro group and one in the regular insulin group, with no clear difference between the groups (RR 0.35, 95% CI 0.02 to 8.08). Macrosomia, perinatal deaths, episodes of birth trauma including shoulder dystocia, nerve palsy, and fracture, and the composite outcome measure of neonatal morbidity were not reported.2. One trial (N = 42 women) compared human insulin to animal insulin, and provided very low-quality evidence for the outcomes. There were no cases of macrosomia in the human insulin group and two in the animal insulin group, with no clear difference between the groups (RR 0.22, 95% CI 0.01 to 4.30). Perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy and fracture and the composite outcome measure of neonatal morbidity were not reported.3. One trial (N = 93 women) compared pre-mixed insulin (70 NPH/30 REG) to self-mixed, split-dose insulin and provided very low-quality evidence to support the outcomes. Two cases of macrosomia were reported in the pre-mixed insulin group and four in the self-mixed insulin group, with no clear difference between the two groups (RR 0.49, 95% CI 0.09 to 2.54). There were seven cases of caesarean section (for cephalo-pelvic disproportion) in the pre-mixed insulin group and 12 in the self-mixed insulin group, with no clear difference between groups (RR 0.57, 95% CI 0.25 to 1.32). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome measure of neonatal morbidity were not reported.4. In the same trial (N = 93 women), insulin injected with a Novolin pen was compared to insulin injected with a conventional needle (syringe), which provided very low-quality evidence to support the outcomes. There was one case of macrosomia in the pen group and five in the needle group, with no clear difference between the different insulin regimens (RR 0.21, 95% CI 0.03 to 1.76). There were five deliveries by caesarean section in the pen group compared with 14 in the needle group; women were less likely to deliver via caesarean section when insulin was injected with a pen compared to a conventional needle (RR 0.38, 95% CI 0.15 to 0.97). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture, and the composite outcome measure of neonatal morbidity were not reported.5. One trial (N = 223 women) comparing insulin Aspart with human insulin reported none of the review's primary outcomes: macrosomia, perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia. nerve palsy, or fracture, or the composite outcome measure of neonatal morbidity.6. One trial (N = 162 women) compared insulin Detemir with NPH insulin, and supported the outcomes with very low-quality evidence. There were three cases of major fetal anomalies in the insulin Detemir group and one in the NPH insulin group, with no clear difference between the groups (RR 3.15, 95% CI 0.33 to 29.67). Macrosomia, perinatal death, pre-eclampsia, caesarean section, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome of neonatal morbidity were not reported. AUTHORS' CONCLUSIONS: With limited evidence and no meta-analyses, as each trial looked at a different comparison, no firm conclusions could be made about different insulin types and regimens in pregnant women with pre-existing type 1 or 2 diabetes. Further research is warranted to determine who has an increased risk of adverse pregnancy outcome. This would include larger trials, incorporating adequate randomisation and blinding, and key outcomes that include macrosomia, pregnancy loss, pre-eclampsia, caesarean section, fetal anomalies, and birth trauma.
Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Pregnancy Complications/drug therapy , Pregnancy in Diabetics/drug therapy , Female , Humans , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Insulin Aspart/therapeutic use , Insulin Detemir/therapeutic use , Insulin Lispro/therapeutic use , PregnancyABSTRACT
BACKGROUND: Hypertensive disorders in pregnancy are significant contributors to maternal and perinatal morbidity and mortality. These disorders include well-controlled chronic hypertension, gestational hypertension (pregnancy-induced hypertension) and mild pre-eclampsia. The definitive treatment for these disorders is planned early delivery and the alternative is to manage the pregnancy expectantly if severe uncontrolled hypertension is not present, with close maternal and fetal monitoring. There are benefits and risks associated with both, so it is important to establish the safest option. OBJECTIVES: To assess the benefits and risks of a policy of planned early delivery versus a policy of expectant management in pregnant women with hypertensive disorders, at or near term (from 34 weeks onwards). SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth Trials Register (12 January 2016) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials of a policy of planned early delivery (by induction of labour or by caesarean section) compared with a policy of delayed delivery ("expectant management") for women with hypertensive disorders from 34 weeks' gestation. Cluster-randomised trials would have been eligible for inclusion in this review, but we found none.Studies using a quasi-randomised design are not eligible for inclusion in this review. Similarly, studies using a cross-over design are not eligible for inclusion, because they are not a suitable study design for investigating hypertensive disorders in pregnancy. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed eligibility and risks of bias. Two review authors independently extracted data. Data were checked for accuracy. MAIN RESULTS: We included five studies (involving 1819 women) in this review.There was a lower risk of composite maternal mortality and severe morbidity for women randomised to receive planned early delivery (risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.83, two studies, 1459 women (evidence graded high)). There were no clear differences between subgroups based on our subgroup analysis by gestational age, gestational week or condition. Planned early delivery was associated with lower risk of HELLP syndrome (RR 0.40, 95% CI 0.17 to 0.93, 1628 women; three studies) and severe renal impairment (RR 0.36, 95% CI 0.14 to 0.92, 100 women, one study).There was not enough information to draw any conclusions about the effects on composite infant mortality and severe morbidity. We observed a high level of heterogeneity between the two studies in this analysis (two studies, 1459 infants, I2 = 87%, Tau2 = 0.98), so we did not pool data in meta-analysis. There were no clear differences between subgroups based on our subgroup analysis by gestational age, gestational week or condition. Planned early delivery was associated with higher levels of respiratory distress syndrome (RR 2.24, 95% CI 1.20 to 4.18, three studies, 1511 infants), and NICU admission (RR 1.65, 95% CI 1.13 to 2.40, four studies, 1585 infants).There was no clear difference between groups for caesarean section (RR 0.91, 95% CI 0.78 to 1.07, 1728 women, four studies, evidence graded moderate), or in the duration of hospital stay for the mother after delivery of the baby (mean difference (MD) -0.16 days, 95% CI -0.46 to 0.15, two studies, 925 women, evidence graded moderate) or for the baby (MD -0.20 days, 95% CI -0.57 to 0.17, one study, 756 infants, evidence graded moderate).Two fairly large, well-designed trials with overall low risk of bias contributed the majority of the evidence. Other studies were at low or unclear risk of bias. No studies attempted to blind participants or clinicians to group allocation, potentially introducing bias as women and staff would have been aware of the intervention and this may have affected aspects of care and decision-making.The level of evidence was graded high (composite maternal mortality and morbidity), moderate (caesarean section, duration of hospital stay after delivery for mother, and duration of hospital stay after delivery for baby) or low (composite infant mortality and morbidity). Where the evidence was downgraded, it was mostly because the confidence intervals were wide, crossing both the line of no effect and appreciable benefit or harm. AUTHORS' CONCLUSIONS: For women suffering from hypertensive disorders of pregnancy after 34 weeks, planned early delivery is associated with less composite maternal morbidity and mortality. There is no clear difference in the composite outcome of infant mortality and severe morbidity; however, this is based on limited data (from two trials) assessing all hypertensive disorders as one group.Further studies are needed to look at the different types of hypertensive diseases and the optimal timing of delivery for these conditions. These studies should also include infant and maternal morbidity and mortality outcomes, caesarean section, duration of hospital stay after delivery for mother and duration of hospital stay after delivery for baby.An individual patient meta-analysis on the data currently available would provide further information on the outcomes of the different types of hypertensive disease encountered in pregnancy.
Subject(s)
Cesarean Section , Hypertension , Labor, Induced , Pregnancy Complications, Cardiovascular , Watchful Waiting , Cesarean Section/statistics & numerical data , Delivery, Obstetric , Female , Gestational Age , Humans , Infant , Infant Mortality , Infant, Newborn , Labor, Induced/statistics & numerical data , Length of Stay , Maternal Mortality , Pre-Eclampsia , Pregnancy , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Immediate delivery of the preterm fetus with suspected compromise may decrease the risk of damage due to intrauterine hypoxia. However, it may also increase the risks of prematurity. OBJECTIVES: To assess the effects of immediate versus deferred delivery of preterm babies with suspected fetal compromise on neonatal, maternal and long-term outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2016) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials comparing a policy of immediate delivery with deferred delivery or expectant management in preterm fetuses with suspected in utero compromise. Quasi-randomised trials and trials employing a cluster-randomised design were eligible for inclusion but none were identified. 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: We included one trial of 548 women (588 babies) in the review. Women with pregnancies between 24 and 36 weeks' gestation took part. The study took place in 13 European countries, between 1993 and 2001. The difference in the median randomisation to delivery interval between immediate delivery and deferred delivery was four days (median: 0.9 (inter-quartile range (IQR) 0.4 to 1.3) days for immediate delivery, median: 4.9 (IQR 2.0 to 10.8) days in the delay group).There was no clear difference in the primary outcomes of extended perinatal mortality (risk ratio (RR) 1.17, 95% confidence interval (CI) 0.67 to 2.04, one trial, 587 babies, moderate-quality evidence) or the composite outcome of death or disability at or after two years of age (RR 1.22, 95% CI 0.85 to 1.75, one trial, 573 babies, moderate-quality evidence) with immediate delivery compared to deferred delivery. The results for these outcomes are consistent with both appreciable benefit and harm. More babies in the immediate delivery group were ventilated for more than 24 hours (RR 1.54, 95% CI 1.20 to 1.97, one trial, 576 babies). There were no differences between the immediate delivery and deferred delivery groups in any other infant mortality outcome (stillbirth, neonatal mortality, postneonatal mortality > 28 days to discharge), individual neonatal morbidity or markers of neonatal morbidity (cord pH less than 7.00, Apgar less than seven at five minutes, convulsions, interventricular haemorrhage or germinal matrix haemorrhage, necrotising enterocolitis and periventricular leucomalacia or ventriculomegaly).Some important outcomes were not reported, in particular infant admission to neonatal intensive care or special care facility, and respiratory distress syndrome. We were not able to calculate composite rates of serious neonatal morbidity, even though individual morbidities were reported, due to the risk of double counting infants with more than one morbidity.More children in the immediate delivery group had cerebral palsy at or after two years of age (RR 5.88, 95% CI 1.33 to 26.02, one trial, 507 children). There were, however, no differences in neurodevelopment impairment at or after two years (RR 1.72, 95% CI 0.86 to 3.41, one trial, 507 children), death at or after two years of age (RR 1.04, 95% CI 0.66 to 1.63, one trial, 573 children), or death or disability in childhood (six to 13 years of age) (RR 0.82, 95% CI 0.48 to 1.40, one trial, 302 children). More women in the immediate delivery group had caesarean delivery than in the deferred delivery group (RR 1.15, 95% CI 1.07 to 1.24, one trial, 547 women, high-quality evidence). Data were not available on any other maternal outcomes.There were several methodological weaknesses in the included study, and the level of evidence for the primary outcomes was graded high for caesarean section and moderate for extended perinatal mortality and death or disability at or after two years. The evidence was downgraded because the CIs for these outcomes were wide, and were consistent with both appreciable benefit and harm. Bias may have been introduced by several factors: blinding was not possible due to the nature of the intervention, data for childhood follow-up were incomplete due to attrition, and no adjustment was made in the analysis for the non-independence of babies from multiple pregnancies (39 out of 548 pregnancies). This study only included cases of suspected fetal compromise where there was uncertainty whether immediate delivery was indicated, thus results must be interpreted with caution. AUTHORS' CONCLUSIONS: Currently there is insufficient evidence on the benefits and harms of immediate delivery compared with deferred delivery in cases of suspected fetal compromise at preterm gestations to make firm recommendations. There is a lack of trials addressing this question, and limitations of the one included trial means that caution must be used in interpreting and generalising the findings. More research is needed to guide clinical practice.Although the included trial is relatively large, it has insufficient power to detect differences in neonatal mortality. It did not report any maternal outcomes other than mode of delivery, or evaluate maternal satisfaction or economic outcomes. The applicability of the findings is limited by several factors: Women with a wide range of obstetric complications and gestational ages were included, and subgroup analysis is currently limited. Advances in Doppler assessment techniques may diagnose severe compromise more accurately and help make decisions about the timing of delivery. The potential benefits of deferring delivery for longer or shorter periods cannot be presumed.Where there is uncertainty whether or not to deliver a preterm fetus with suspected fetal compromise, there seems to be no benefit to immediate delivery. Deferring delivery until test results worsen or increasing gestation favours delivery may improve the outcomes for mother and baby.There is a need for high-quality randomised controlled trials comparing immediate and deferred delivery where there is suspected fetal compromise at preterm gestations to guide clinical practice. Future trials should report all important outcomes, and should be adequately powered to detect differences in maternal and neonatal morbidity and mortality.
Subject(s)
Delivery, Obstetric/methods , Fetal Distress/complications , Infant, Premature , Cerebral Palsy/etiology , Cesarean Section/statistics & numerical data , Delivery, Obstetric/adverse effects , Female , Humans , Infant , Infant Mortality , Infant, Newborn , Pregnancy , Randomized Controlled Trials as Topic , Respiration, Artificial/statistics & numerical data , Watchful WaitingABSTRACT
BACKGROUND: Diabetes results in a rise in blood glucose above normal physiological levels; if untreated this may cause damage to many systems including the cardiovascular and renal systems. Pregnancy increases resistance to insulin action; for those women who have pre-gestational diabetes, this results in an increasing insulin requirement. There are several methods of administering insulin. Conventionally, insulin has been administered subcutaneously, formally referred to as intensive conventional treatment, but now more usually referred to as multiple daily injections (MDI). An alternative method of insulin administration is the continuous subcutaneous insulin infusion pump (CSII). OBJECTIVES: To compare CSII with MDI of insulin for pregnant women with pre-existing and gestational diabetes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2016) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials comparing CSII with MDI for pregnant women with diabetes. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed studies and two review authors extracted data. Disagreements were resolved through discussion with the third author. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included five single-centre trials (undertaken in Italy) with 153 women and 154 pregnancies in this review.There were no clear differences in the primary outcomes reported between CSII and MDI in the included trials: caesarean section (risk ratio (RR) 1.09, 95% confidence interval (CI) 0.66 to 1.77; three trials, 71 women, evidence graded very low), large-for-gestational age (RR 4.15, 95% CI 0.49 to 34.95; three trials, 73 infants; evidence graded very low), and perinatal mortality (RR 2.33, 95% CI 0.38 to 14.32; four trials, 83 infants, evidence graded very low). Other primary outcomes were not reported in these trials (hypertensive disorders of pregnancy, development of type 2 diabetes, composite outcome of serious neonatal outcomes, and neurosensory disability).There was no clear evidence of differences in the maternal secondary outcomes: maternal weight gain during pregnancy, 24 hour mean blood glucose in each trimester, mean maternal HbA1c in each trimester, maternal hypoglycaemia, and maternal hyperglycaemia. The included studies did not report several GRADE outcomes: perineal trauma, return to pre-pregnancy weight, postnatal depression, induction of labour. Many maternal secondary outcomes were also not reported.In two trials, including a total of 61 infants, CSII was associated with an increase in mean birthweight compared with MDI (mean difference (MD) 220.56 g, 95% CI -2.09 g to 443.20 g; P = 0.05). However, the large CI including anything from a small reduction to an increase in mean birthweight and the lack of a difference in macrosomia rate (RR 3.20, CI 0.14 to 72.62; two trials, 61 infants) suggests uncertainty. Large-for-gestational age (see above), andsmall-for-gestational age also suggests uncertainty of effect. No significant differences were found in: gestation at delivery, preterm birth < 37 weeks' gestation, preterm birth < 32 weeks' gestation, neonatal hypoglycaemia (evidence graded very low), respiratory distress syndrome, neonatal hyperbilirubinaemia, and fetal anomaly. There were no data reported on many important infant outcomes, including the GRADE outcomes adiposity and diabetes. There was no follow-up of infants in childhood or adulthood, so longer-term outcomes were not reported.The only outcome reported for use of health service resources wasmaternal days hospitalised, which did not show a difference between groups in the small number of women included (MD 9.40, CI -6.04 to 24.84; one trial, 10 women).The methods used by the trials were poorly reported, for example although blinding of participants and clinicians regarding intervention allocation is impossible, it is possible to blind assessors and this along with other aspects of trial methods was not reported, which means that the trials are at an unclear or high risk of bias. We do not know if the women who participated were representative, and therefore if the results can be generalised. Most GRADE outcomes were not reported. For the GRADE outcomes that were reported, our assessment was that the evidence is very low quality (caesarean section, large-for-gestational age, perinatal mortality, andneonatal hypoglycaemia). This was due to design limitations in the included trials, small sample sizes in the trials contributing data, wide CIs crossing both the line of no effect and the line of appreciable benefit and/or harm, and often few events. We are therefore uncertain whether CSII or MDI improves outcomes for pregnant women with diabetes and their infants, and the results of further studies may differ substantially from those presented in this review. AUTHORS' CONCLUSIONS: There is no evidence to support the use of one particular form of insulin administration over another for pregnant women with diabetes. There are only a small number of trials appropriate for meta-analysis, a small number of women included and questionable generalisability of the trial population.Pump technology has progressed since these trials were undertaken. Well-designed randomised trials are required to evaluate comparisons such as patch pumps against MDI and more conventional CSII against MDI. These trials should be adequately powered to assess the effect of interventions, and report the core set of outcomes used in Cochrane reviews of diabetes in pregnancy. Trials to assess the effects of pumps on birthweight and macrosomia rates are needed. It would be beneficial for future trials to undertake longer-term follow-up of participants and their infants, assess women's preferences, and conduct an economic evaluation.
Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Pregnancy in Diabetics , Birth Weight , Female , Humans , Injections, Subcutaneous , Pregnancy , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Leg cramps are a common problem in pregnancy. Various interventions have been used to treat them, including drug, electrolyte and vitamin therapies, and non-drug therapies. OBJECTIVES: To assess the effectiveness and safety of different interventions for treating leg cramps in pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Register (31 March 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) of any intervention (drug, electrolyte, vitamin or non-drug therapies) for treatment of leg cramps in pregnancy compared with placebo, no treatment or other treatment. Quinine was excluded for its known adverse effects (teratogenicity). Cluster-RCTS were considered for inclusion. Quasi-RCTs and cross-over studies were excluded. 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: We included six studies (390 women). Four trials compared oral magnesium with placebo/no treatment, two compared oral calcium with no treatment, one compared oral vitamin B versus no treatment, and one compared oral calcium with oral vitamin C. Two of the trials were well-conducted and reported, the other four had design limitations. The process of random allocation was sub-optimal in three studies, and blinding was not attempted in two. Outcomes were reported in different ways, precluding the use of meta-analysis and limiting the strength of our conclusions.The 'no treatment' group in one four-arm trial has been used as the comparison group for the composite outcome (intensity and frequency of leg cramps) in magnesium, calcium, and vitamin B versus no treatment. This gives it disproportionate weight in the overall analysis, thus interpretation of these results should be cautious. Oral magnesium versus placebo/no treatmentMagnesium (taken orally for two to four weeks) did not consistently reduce the frequency of leg cramps compared with placebo or no treatment. Outcomes that showed differences were: frequency of leg cramps after treatment: never, and twice a week (risk ratio (RR) 5.66, 95% confidence interval (CI) 1.35 to 23.68, one trial, 69 women, evidence graded low; RR 0.29, 95% CI 0.11 to 0.80, one trial, 69 women), and frequency of leg cramps: 50% reduction in number of leg cramps after treatment (RR 1.42, 95% CI 1.09 to 1.86, one trial, 86 women, evidence graded low). The outcomes that showed no difference were: frequency of leg cramps during two weeks of treatment (mean difference (MD) 1.80, 95% CI -1.32 to 4.92, one trial, 38 women, evidence graded low); frequency of leg cramps after treatment: daily, every other day, and once a week (RR 1.20, 95% CI 0.45 to 3.21, one trial, 69 women; RR 0.44, 95% CI 0.12 to 1.57, one trial, 69 women; RR 1.54, 95% CI 0.62 to 3.87, one trial, 69 women).Evidence about whether magnesium supplements reduced the intensity of pain was inconclusive, with two studies showing that it may slightly reduce pain, while one showed no difference. There were no differences in the experience of side effects (including nausea, flatulence, diarrhoea and intestinal air) between pregnant women receiving magnesium compared with placebo/no treatment. Oral calcium versus no treatmentA greater proportion of women receiving calcium supplements experienced no leg cramps after treatment than those receiving no treatment (frequency of leg cramps after treatment: never RR 8.59, 95% CI 1.19 to 62.07, one study, 43 women, evidence graded very low). There was no difference between groups for a composite outcome (intensity and frequency) for partial improvement (RR 0.64, 95% CI 0.36 to 1.15, one trial, 42 women); however, the same trial showed a greater proportion of women experiencing no leg cramps after treatment with calcium compared with no treatment (RR 5.50, 95% CI 1.38 to 21.86).Other secondary outcomes, including side effects, were not reported. Oral vitamin B versus no treatment Frequency of leg cramps was not reported in the one included trial. According to a composite outcome (frequency and intensity), more women receiving vitamin B fully recovered compared with those receiving no treatment (RR 7.50, 95% CI 1.95 to 28.81). Those women receiving no treatment were more likely to experience a partial improvement in the intensity and frequency of leg cramps than those taking vitamin B (RR 0.29, 95% CI 0.11 to 0.73, one trial, 42 women), or to see no change in their condition. However, these results are based on one small study with design limitations.Other secondary outcomes, including side effects, were not reported. Oral calcium versus oral vitamin CThere was no difference in the frequency of leg cramps after treatment with calcium versus vitamin C (RR 1.33, 95% CI 0.53 to 3.38, one study, 60 women, evidence graded very low). Other outcomes, includingside effects, were not reported. AUTHORS' CONCLUSIONS: It is unclear from the evidence reviewed whether any of the interventions (oral magnesium, oral calcium, oral vitamin B or oral vitamin C) provide an effective treatment for leg cramps. This is primarily due to outcomes being measured and reported in different, incomparable ways, and design limitations compromising the quality of the evidence (the level of evidence was graded low or very low). This was mainly due to poor study design and trials being too small to address the question satisfactorily.Adverse outcomes were not reported, other than side effects for magnesium versus placebo/no treatment. It is therefore not possible to assess the safety of these interventions.The inconsistency in the measurement and reporting of outcomes, meant that data could not be pooled, meta-analyses could not be carried out, and comparisons between studies are difficult.The review only identified trials of oral interventions (magnesium, calcium, vitamin B or vitamin C) to treat leg cramps in pregnancy. None of the trials considered non-drug therapies, for example, muscle stretching, massage, relaxation, heat therapy, and dorsiflexion of the foot. This limits the completeness and applicability of the evidence.Standardised measures for assessing the frequency, intensity and duration of leg cramps to be used in large well-conducted randomised controlled trials are needed to answer this question. Trials of non-drug therapies are also needed.
Subject(s)
Muscle Cramp/therapy , Pregnancy Complications/therapy , Administration, Oral , Adult , Ascorbic Acid/administration & dosage , Calcium/administration & dosage , Female , Humans , Leg , Magnesium/administration & dosage , Pain Management/methods , Pregnancy , Randomized Controlled Trials as Topic , Vitamin B Complex/administration & dosage , Vitamins/administration & dosageABSTRACT
BACKGROUND: In a vaginal breech birth there may be benefit from rapid delivery of the baby to prevent progressive acidosis. However, this needs to be weighed against the potential trauma of a quick delivery. OBJECTIVES: The objective of this review was to assess the effects of expedited vaginal delivery (breech delivery from umbilicus to delivery of the head within one contraction) on perinatal outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials of expedited vaginal breech delivery compared with delivery not routinely expedited in women undergoing vaginal breech delivery. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the one identified trial for inclusion.If studies are included in future updates, two review authors will assess risk of bias, extract data and check data for accuracy. MAIN RESULTS: No studies were included. AUTHORS' CONCLUSIONS: There is not enough evidence to evaluate the effects of expedited vaginal breech delivery.
Subject(s)
Breech Presentation , Delivery, Obstetric/methods , Female , Humans , PregnancyABSTRACT
BACKGROUND: Management of breech presentation is controversial, particularly in regard to manipulation of the position of the fetus by external cephalic version (ECV). ECV may reduce the number of breech presentations and caesarean sections, but there also have been reports of complications with the procedure. OBJECTIVES: The objective of this review was to assess the effects of ECV at or near term on measures of pregnancy outcome. Methods of facilitating ECV, and ECV before term are reviewed separately. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Trials Register (28 February 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials of ECV at or near term (with or without tocolysis) compared with no attempt at ECV in women with breech presentation. DATA COLLECTION AND ANALYSIS: Two review authors assessed eligibility and trial quality, and extracted the data. MAIN RESULTS: We included eight studies, with a total of 1308 women randomised. The pooled data from these studies show a statistically significant and clinically meaningful reduction in non-cephalic presentation at birth (average risk ratio (RR) 0.42, 95% confidence interval (CI) 0.29 to 0.61, eight trials, 1305 women); vaginal cephalic birth not achieved (average RR 0.46, 95% CI 0.33 to 0.62, seven trials, 1253 women, evidence graded very low); and caesarean section (average RR 0.57, 95% CI 0.40 to 0.82, eight trials, 1305 women, evidence graded very low) when ECV was attempted in comparison to no ECV attempted. There were no significant differences in the incidence of Apgar score ratings below seven at one minute (average RR 0.67, 95% CI 0.32 to 1.37, three trials, 168 infants) or five minutes (RR 0.63, 95% CI 0.29 to 1.36, five trials, 428 infants, evidence graded very low), low umbilical vein pH levels (RR 0.65, 95% CI 0.17 to 2.44, one trial, 52 infants, evidence graded very low), neonatal admission (RR 0.80, 95% CI 0.48 to 1.34, four trials, 368 infants, evidence graded very low), perinatal death (RR 0.39, 95% CI 0.09 to 1.64, eight trials, 1305 infants, evidence graded low), nor time from enrolment to delivery (mean difference -0.25 days, 95% CI -2.81 to 2.31, two trials, 256 women).All of the trials included in this review had design limitations, and the level of evidence was graded low or very low. No studies attempted to blind the intervention, and the process of random allocation was suboptimal in several studies. Three of the eight trials had serious design limitations, however excluding these studies in a sensitivity analysis for outcomes with substantial heterogeneity did not alter the results. AUTHORS' CONCLUSIONS: Attempting cephalic version at term reduces the chance of non-cephalic presentation at birth, vaginal cephalic birth not achieved and caesarean section. There is not enough evidence from randomised trials to assess complications of ECV at term. Large observational studies suggest that complications are rare.