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1.
Cochrane Database Syst Rev ; 8: CD011625, 2020 08 05.
Artigo em Inglês | MEDLINE | ID: mdl-32761813

RESUMO

BACKGROUND: Postpartum constipation, with symptoms, such as pain or discomfort, straining, and hard stool, is a common condition affecting mothers. Haemorrhoids, pain at the episiotomy site, effects of pregnancy hormones, and haematinics used in pregnancy can increase the risk of postpartum constipation. Eating a high-fibre diet and increasing fluid intake are usually encouraged. Although laxatives are commonly used in relieving constipation, the effectiveness and safety of available interventions for preventing postpartum constipation should be ascertained. This is an update of a review first published in 2015. OBJECTIVES: To evaluate the effectiveness and safety of interventions for preventing postpartum constipation. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, and two trials registers ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 October 2019), and screened reference lists of retrieved trials. SELECTION CRITERIA: We considered all randomised controlled trials (RCTs) comparing any intervention for preventing postpartum constipation versus another intervention, placebo, or no intervention in postpartum women. Interventions could include pharmacological (e.g. laxatives) and non-pharmacological interventions (e.g. acupuncture, educational and behavioural interventions). Quasi-randomised trials and cluster-RCTs were eligible for inclusion; none were identified. Trials using a cross-over design were not eligible. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the results of the search to select potentially relevant trials, extracted data, assessed risk of bias, and the certainty of the evidence, using the GRADE approach. We did not pool results in a meta-analysis, but reported them per study. MAIN RESULTS: We included five trials (1208 postpartum mothers); three RCTs and two quasi-RCTs. Four trials compared a laxative with placebo; one compared a laxative plus a bulking agent versus the same laxative alone, in women who underwent surgical repair of third degree perineal tears. Trials were poorly reported, and four of the five trials were published over 40 years ago. We judged the risk of bias to be unclear for most domains. Overall, we found a high risk of selection and attrition bias. Laxative versus placebo We included four trials in this comparison. Two of the trials examined the effects of laxatives that are no longer used; one has been found to have carcinogenic properties (Danthron), and the other is not recommended for lactating women (Bisoxatin acetate); therefore, we did not include their results in our main findings. None of the trials included in this comparison assessed our primary outcomes: pain or straining on defecation, incidence of postpartum constipation, or quality of life; or many of our secondary outcomes. A laxative (senna) may increase the number of women having their first bowel movement within 24 hours after delivery (risk ratio (RR) 2.90, 95% confidence interval (CI) 2.24 to 3.75; 1 trial, 471 women; low-certainty evidence); may have little or no effect on the number of women having their first bowel movement on day one after delivery (RR 0.94, 95% CI 0.72 to 1.22; 1 trial, 471 women; very low-certainty evidence); may reduce the number of women having their first bowel movement on day two (RR 0.23, 95% CI 0.11 to 0.45; 1 trial, 471 women; low-certainty evidence); and day three (RR 0.05, 95% CI 0.00 to 0.89; 1 trial, 471 women; low-certainty evidence); and may have little or no effect on the number of women having their first bowel movement on day four after delivery (RR 0.22, 95% CI 0.03 to 1.87; 1 trial, 471 women; very low-certainty evidence), but some of the evidence is very uncertain. Adverse effects were poorly reported. Low-certainty evidence suggests that the laxative (senna) may increase the number of women experiencing abdominal cramps (RR 4.23, 95% CI 1.75 to 10.19; 1 trial, 471 women). Very low-certainty evidence suggests that laxatives taken by the mother may have little or no effect on loose stools in the baby (RR 0.62, 95% CI 0.16 to 2.41; 1 trial, 281 babies); or diarrhoea (RR 2.46, 95% CI 0.23 to 26.82; 1 trial, 281 babies). Laxative plus bulking agent versus laxative only Very low-certainty evidence from one trial (147 women) suggests no evidence of a difference between these two groups of women who underwent surgical repair of third degree perineal tears; only median and range data were reported. The trial also reported no evidence of a difference in the incidence of postpartum constipation (data not reported), but did not report on quality of life. Time to first bowel movement was reported as a median (range); very low-certainty evidence suggests little or no difference between the two groups. A laxative plus bulking agent may increase the number of women having any episode of faecal incontinence during the first 10 days postpartum (RR 1.81, 95% CI 1.01 to 3.23; 1 trial, 147 women; very low-certainty evidence). The trial did not report on adverse effects of the intervention on babies, or many of our secondary outcomes. AUTHORS' CONCLUSIONS: There is insufficient evidence to make general conclusions about the effectiveness and safety of laxatives for preventing postpartum constipation. The evidence in this review was assessed as low to very low-certainty evidence, with downgrading decisions based on limitations in study design, indirectness and imprecision. We did not identify any trials assessing educational or behavioural interventions. We identified four trials that examined laxatives versus placebo, and one that examined laxatives versus laxatives plus stool bulking agents. Further, rigorous trials are needed to assess the effectiveness and safety of laxatives during the postpartum period for preventing constipation. Trials should assess educational and behavioural interventions, and positions that enhance defecation. They should report on the primary outcomes from this review: pain or straining on defecation, incidence of postpartum constipation, quality of life, time to first bowel movement after delivery, and adverse effects caused by the intervention, such as: nausea or vomiting, pain, and flatus.


Assuntos
Constipação Intestinal/prevenção & controle , Fibras na Dieta/uso terapêutico , Laxantes/uso terapêutico , Transtornos Puerperais/prevenção & controle , Adulto , Defecação , Fibras na Dieta/efeitos adversos , Feminino , Humanos , Laxantes/efeitos adversos , Períneo/lesões , Período Pós-Parto , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo
2.
Cochrane Database Syst Rev ; 5: CD013633, 2020 05 26.
Artigo em Inglês | MEDLINE | ID: mdl-32452555

RESUMO

BACKGROUND: Preterm birth is a serious and common pregnancy complication. The burden is particularly high in low- and middle-income countries where available care is often inadequate to ensure preterm newborn survival. Administration of antenatal corticosteroids (ACS) is recommended as the standard care for the management of women at risk of imminent preterm birth but its coverage varies globally. Efforts to improve preterm newborn survival have largely been focused on optimising the coverage of ACS use. However, the benefits and harms of such strategies are unclear. OBJECTIVES: To determine the relative benefits and risks of individual patient protocols, health service policies, educational interventions or other strategies which aim to optimise the use of ACS for anticipated preterm birth. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (26 September 2019), and reference lists of retrieved studies. SELECTION CRITERIA: We planned to include randomised controlled trials (RCTs), randomised at individual or cluster level, and quasi-randomised trials that assessed strategies to optimise (either by increasing or restricting) the administration of ACS compared with usual care amongst women at risk of preterm birth. Our primary outcomes were perinatal death and a composite outcome of offspring mortality and early or late neurodevelopmental morbidity. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. All three review authors independently extracted data and assessed risk of bias. We used narrative synthesis to analyse results, as we were unable to pool data from the included studies. We assessed the certainty of evidence using the GRADE approach. MAIN RESULTS: We included three cluster-RCTs, all assessing the effects of a multifaceted strategy aiming to promote the use of ACS among women at risk of preterm birth. We did not identify any trials assessing strategies to restrict the use of ACS versus usual care. Two of the included trials assessed use of ACS in high-resource hospital settings. The third trial, the Antenatal Corticosteroid Trial (ACT) was a multi-site trial conducted in rural and semi-urban settings of six low- and middle-income countries in South Asia, sub-Saharan Africa and Central and South America. In two trials, promoting the use of ACS resulted in increased use of ACS, whereas one trial did not find a difference in the rate of ACS administration compared to usual care. Whilst we included three studies, we were unable to pool the data in meta-analysis due to outcomes not being reported across all studies, or outcome results being reported in different ways. The main source of data in this review is from the ACT trial. We assessed the ACT trial as high risk for performance and selective reporting bias. In the protocol for this review, we planned to report all settings and subgroup by low-middle versus high-income countries; these planned analyses were not possible in this version of the review, although adding further studies in future updates may allow us to carry out planned subgroup analyses. The ACT trial was conducted in low-resource settings and reported data on appropriate ACS treatment and inappropriate ACS treatment. Although a strategy of promoting the administration of ACS compared to routine care may increase appropriate ACS treatment (RR 4.34, 95%CI 3.59 to 5.25; 1 study; n = 4389; low-certainty evidence), it may also increase inappropriate ACS treatment (RR 9.11 95%CI 8.04 to 10.33, 1 study, n = 89,237; low-certainty evidence). In low-resource settings, a strategy of promoting the administration of ACS probably increases population level perinatal death by 3 per 1000 infants (risk ratio (RR) 1.11, 95% confidence interval (CI) 1.04 to 1.19; 1 study; n = 100,705; moderate-certainty evidence); stillbirth by 2 per 1000 infants (RR 1.11, 95% CI 1.02 to 1.21; 1 study; n = 100,705; moderate-certainty evidence); and neonatal death before 28 days by 2 per 1000 infants (RR 1.12, 95% CI 1.02 to 1.23; 1 study; n = 100,705; moderate-certainty evidence); may increase the risk for 'suspected' maternal infection or inflammation (RR 1.49, 95% CI 1.32 to 1.68; 1 study; n = 99,742; low-certainty evidence); and make little or no difference to the risk of maternal mortality (RR 1.11, 95% CI 0.64 to 1.92; 1 study; n = 99,742; low-certainty evidence) compared to routine care. Included trials did not report on the composite outcomes offspring mortality, early neurodevelopmental morbidity or late neurodevelopmental morbidity; and offspring mortality or severe neonatal morbidity. AUTHORS' CONCLUSIONS: In low-resource settings, a strategy of actively promoting the use of ACS in women at risk of preterm birth may increase ACS use in the target population, but may also carry a substantial risk of unnecessary exposure of ACS to women in whom ACS is not indicated. At the population level, these effects are probably associated with increased risks of stillbirth, perinatal death, neonatal death before 28 days, and maternal infection. The findings of this review support a more conservative approach to clinical protocols and clinical decision-making particularly in low-resource settings, along the lines of the World Health Organization's ACS 2015 recommendations, which take into account both the established clinical efficacy of ACS when used in the correct situation and context, and the possibility of important adverse effects when certain conditions are not met. Given the unanticipated results of the ACT trial, further research on strategies to optimise the use of ACS in low-resource settings is justified.


Assuntos
Corticosteroides/administração & dosagem , Nascimento Prematuro , Corticosteroides/efeitos adversos , Países Desenvolvidos , Países em Desenvolvimento , Feminino , Humanos , Prescrição Inadequada , Recém-Nascido , Recém-Nascido Prematuro , Morte Perinatal , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Natimorto/epidemiologia
3.
Cochrane Database Syst Rev ; 5: CD010919, 2019 05 20.
Artigo em Inglês | MEDLINE | ID: mdl-31106396

RESUMO

BACKGROUND: Ambient air pollution is associated with a large burden of disease in both high-income countries (HICs) and low- and middle-income countries (LMICs). To date, no systematic review has assessed the effectiveness of interventions aiming to reduce ambient air pollution. OBJECTIVES: To assess the effectiveness of interventions to reduce ambient particulate matter air pollution in reducing pollutant concentrations and improving associated health outcomes. SEARCH METHODS: We searched a range of electronic databases with diverse focuses, including health and biomedical research (CENTRAL, Cochrane Public Health Group Specialised Register, MEDLINE, Embase, PsycINFO), multidisciplinary research (Scopus, Science Citation Index), social sciences (Social Science Citation Index), urban planning and environment (Greenfile), and LMICs (Global Health Library regional indexes, WHOLIS). Additionally, we searched grey literature databases, multiple online trial registries, references of included studies and the contents of relevant journals in an attempt to identify unpublished and ongoing studies, and studies not identified by our search strategy. The final search date for all databases was 31 August 2016. SELECTION CRITERIA: Eligible for inclusion were randomized and cluster randomized controlled trials, as well as several non-randomized study designs, including controlled interrupted time-series studies (cITS-EPOC), interrupted time-series studies adhering to EPOC standards (ITS-EPOC), interrupted time-series studies not adhering to EPOC standards (ITS), controlled before-after studies adhering to EPOC standards (CBA-EPOC), and controlled before-after studies not adhering to EPOC standards (CBA); these were classified as main studies. Additionally, we included uncontrolled before-after studies (UBA) as supporting studies. We included studies that evaluated interventions to reduce ambient air pollution from industrial, residential, vehicular and multiple sources, with respect to their effect on mortality, morbidity and several air pollutant concentrations. We did not restrict studies based on the population, setting or comparison. DATA COLLECTION AND ANALYSIS: After a calibration exercise among the author team, two authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We conducted data extraction, risk of bias assessment and evidence synthesis only for main studies; we mapped supporting studies with regard to the types of intervention and setting. To assess risk of bias, we used the Graphic Appraisal Tool for Epidemiological studies (GATE) for correlation studies, as modified and employed by the Centre for Public Health Excellence at the UK National Institute for Health and Care Excellence (NICE). For each intervention category, i.e. those targeting industrial, residential, vehicular and multiple sources, we synthesized evidence narratively, as well as graphically using harvest plots. MAIN RESULTS: We included 42 main studies assessing 38 unique interventions. These were heterogeneous with respect to setting; interventions were implemented in countries across the world, but most (79%) were implemented in HICs, with the remaining scattered across LMICs. Most interventions (76%) were implemented in urban or community settings.We identified a heterogeneous mix of interventions, including those aiming to address industrial (n = 5), residential (n = 7), vehicular (n = 22), and multiple sources (n = 4). Some specific interventions, such as low emission zones and stove exchanges, were assessed by several studies, whereas others, such as a wood burning ban, were only assessed by a single study.Most studies assessing health and air quality outcomes used routine monitoring data. Studies assessing health outcomes mostly investigated effects in the general population, while few studies assessed specific subgroups such as infants, children and the elderly. No identified studies assessed unintended or adverse effects.The judgements regarding the risk of bias of studies were mixed. Regarding health outcomes, we appraised eight studies (47%) as having no substantial risk of bias concerns, five studies (29%) as having some risk of bias concerns, and four studies (24%) as having serious risk of bias concerns. Regarding air quality outcomes, we judged 11 studies (31%) as having no substantial risk of bias concerns, 16 studies (46%) as having some risk of bias concerns, and eight studies (23%) as having serious risk of bias concerns.The evidence base, comprising non-randomized studies only, was of low or very low certainty for all intervention categories and primary outcomes. The narrative and graphical synthesis showed that evidence for effectiveness was mixed across the four intervention categories. For interventions targeting industrial, residential and multiple sources, a similar pattern emerged for both health and air quality outcomes, with essentially all studies observing either no clear association in either direction or a significant association favouring the intervention. The evidence base for interventions targeting vehicular sources was more heterogeneous, as a small number of studies did observe a significant association favouring the control. Overall, however, the evidence suggests that the assessed interventions do not worsen air quality or health. AUTHORS' CONCLUSIONS: Given the heterogeneity across interventions, outcomes, and methods, it was difficult to derive overall conclusions regarding the effectiveness of interventions in terms of improved air quality or health. Most included studies observed either no significant association in either direction or an association favouring the intervention, with little evidence that the assessed interventions might be harmful. The evidence base highlights the challenges related to establishing a causal relationship between specific air pollution interventions and outcomes. In light of these challenges, the results on effectiveness should be interpreted with caution; it is important to emphasize that lack of evidence of an association is not equivalent to evidence of no association.We identified limited evidence for several world regions, notably Africa, the Middle East, Eastern Europe, Central Asia and Southeast Asia; decision-makers should prioritize the development and implementation of interventions in these settings. In the future, as new policies are introduced, decision-makers should consider a built-in evaluation component, which could facilitate more systematic and comprehensive evaluations. These could assess effectiveness, but also aspects of feasibility, fidelity and acceptability.The production of higher quality and more uniform evidence would be helpful in informing decisions. Researchers should strive to sufficiently account for confounding, assess the impact of methodological decisions through the conduct and communication of sensitivity analyses, and improve the reporting of methods, and other aspects of the study, most importantly the description of the intervention and the context in which it is implemented.


Assuntos
Poluição do Ar/efeitos adversos , Poluição do Ar/prevenção & controle , Nível de Saúde , Material Particulado/efeitos adversos , Humanos , Análise de Séries Temporais Interrompida , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Cochrane Database Syst Rev ; (9): CD011625, 2015 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-26387487

RESUMO

BACKGROUND: Postpartum constipation, with symptoms such as pain or discomfort, straining, and hard stool, is a common condition affecting mothers. Haemorrhoids, pain at the episiotomy site, effects of pregnancy hormones and haematinics used in pregnancy can increase the risk of postpartum constipation. Eating a high-fibre diet and increasing fluid intake is usually encouraged, although laxatives are commonly used in relieving constipation. The effectiveness and safety of available interventions for preventing postpartum constipation needs to be ascertained. OBJECTIVES: To evaluate the effectiveness and safety of interventions for preventing postpartum constipation. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2015), Stellenbosch University database, ProQuest Dissertation and Theses database, World Health Organization International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov (30 April 2015) and reference lists of included studies. SELECTION CRITERIA: All randomised controlled trials (RCTs) comparing any intervention for preventing postpartum constipation versus another intervention, placebo or no intervention. Interventions could include pharmacological (e.g. laxatives) and non-pharmacological interventions (e.g. acupuncture, educational and behavioural interventions).We included quasi-randomised trials. Cluster-RCTs were eligible for inclusion but none were identified. Studies using a cross-over design were not eligible for inclusion in this review. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the results of the search to select potentially relevant studies, extracted data and assessed risk of bias. Results were pooled in a meta-analysis only where there was no substantial statistical heterogeneity. MAIN RESULTS: We included five trials (1208 postpartum mothers); four compared a laxative with placebo and one compared a laxative alone versus the same laxative plus a bulking agent in women who underwent surgical repair of third degree perineal tears. Trials were poorly reported and risk of bias was unclear for most domains. Overall, there was a high risk of selection and attrition bias. Laxative versus placeboNone of the four trials included in this comparison assessed any of our pre-specified primary outcomes (pain or straining on defecation, incidence of postpartum constipation or changes in quality of life).All four trials reported time to first bowel movement (not pre-specified in our protocol). In one trial, more women in the laxative group had their first bowel movement less than 24 hours after delivery compared to women in the placebo group (risk ratio (RR) 2.90, 95% confidence interval (CI) 2.24 to 3.75, 471 women). Individual trials also reported inconsistent results for days one, two and three after delivery. Pooled results of two trials showed that fewer women in the laxative group were having their first bowel movement at day four compared with controls (average RR 0.36, 95% CI 0.21 to 0.61, 671 women).Regarding secondary outcomes, no trials reported on stool consistency using the Bristol stool form scale orrelief of abdominal pain/discomfort . One trial reported the number of women having loose or watery stools and there were more women who experienced this in the laxative group compared to the placebo group (RR 26.96, 95% CI 3.81 to 191.03, 106 women). One trial found no clear difference in the number of enemas between groups (RR 0.63, 95% CI 0.38 to 1.05, 244 women). One trial reported more women having more than two bowel movements per day in the laxative compared to the placebo group (RR 26.02, 95% CI 1.59 to 426.73, 106 women). Adverse effects were poorly reported; two trials reported the number of women having abdominal cramps, but their results could not be pooled in a meta-analysis due to substantial statistical heterogeneity. In one trial, more women in the laxative group had abdominal cramps compared to the placebo group (RR 4.23, 95% CI 1.75 to 10.19, 471 women), while the other trial showed no difference between groups (RR 0.25, 95% CI 0.03 to 2.20, 200 women). With regards to adverse effects of the intervention on the baby , one trial found no difference in the incidence of loose stools (RR 0.62, 95% CI 0.16 to 2.41, 281 women) or diarrhoea (RR 2.46, 95% CI 0.23 to 26.82, 281 women) between the two groups. Laxative versus laxative plus bulking agentOnly one trial was included in this comparison and reported on pain or straining on defecation in women who underwent surgical repair of third degree perineal tears; there was no reported difference between groups (median (range) data only). No difference was reported in the incidence of postpartum constipation (data not reported) and the outcome changes in quality of life was not mentioned.Time to first bowel movement was reported as a median (range) with no difference between the two groups. In terms of adverse effects , women in the laxative plus stool-bulking group were reported to be at a greater risk of faecal incontinence during the immediate postpartum period (median (range) data only). However the number of women having any episode of faecal incontinence during first 10 days postpartum was reported with no clear difference between the two groups (14/77 (18.2%) versus 23/70 (32.9%), RR 0.55, 95% CI 0.31 to 0.99, 147 women). The trial did not report on adverse effects of the intervention on the babies.The trial reported none of the following pre-specified secondary outcomes: stool consistency using Bristol stool form scale , use of alternative products , laxative agents , enemas , relief of abdominal pain/discomfort and stool frequency . AUTHORS' CONCLUSIONS: We did not identify any trials assessing educational or behavioural interventions. We identified four trials that examined laxatives versus placebo and one that examined laxatives versus laxatives plus stool bulking agents. Results from trials were inconsistent and there is insufficient evidence to make general conclusions about the effectiveness and safety of laxatives.Further rigorous trials are needed to assess the effectiveness and safety of laxatives during the postpartum period for preventing constipation. Trials assessing educational and behavioural interventions and positions that enhance defecation are also needed. Future trials should report on the following important outcomes: pain or straining on defecation; incidence of postpartum constipation, quality of life, time to first bowel movement after delivery, and adverse effects caused by the intervention such as: nausea or vomiting, pain and flatus.


Assuntos
Constipação Intestinal/prevenção & controle , Fibras na Dieta/uso terapêutico , Laxantes/uso terapêutico , Período Pós-Parto , Adulto , Feminino , Humanos , Períneo/lesões , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Cochrane Database Syst Rev ; (8): CD010490, 2015 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-26279276

RESUMO

BACKGROUND: The benefits of breastfeeding are well known, and the World Health Organization recommends exclusive breastfeeding for the first six months of life and continuing breastfeeding to age two. However, many women stop breastfeeding due to lactational breast abscesses. A breast abscess is a localised accumulation of infected fluid in breast tissue. Abscesses are commonly treated with antibiotics, incision and drainage (I&D) or ultrasound-guided needle aspiration, but there is no consensus on the optimal treatment. OBJECTIVES: To assess the effects of different treatments for the management of breast abscesses in breastfeeding women. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trial Register (27 February 2015). In addition we searched African Journals Online (27 February 2015), Google Scholar (27 February 2015), ProQuest Dissertations and Theses Databases (27 February 2015) and the WHO International Clinical Trials Registry Platform (ICTRP) search portal (27 February 2015). We also checked reference lists of retrieved studies and contacted experts in the field as well as relevant pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials (RCTs) investigating any intervention for treating lactational breast abscesses compared with any other intervention. Studies published in abstract form, quasi-RCTs and cluster-RCTs were not eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, assessed risk of bias and extracted data. Data were checked for accuracy. MAIN RESULTS: We included six studies. Overall, trials had an unclear risk of bias for most domains due to poor reporting. Two studies did not stratify data for lactational and non-lactational breast abscesses, and these studies do not contribute to the results. This review is based on data from four studies involving 325 women. Needle aspiration (with and without ultrasound guidance) versus incision and drainage (I&D) Mean time (days) to complete resolution of breast abscess (three studies) - there was substantial heterogeneity among these data (Tau(2) = 47.63, I(2) = 97%) and a clear difference between subgroups (with or without ultrasound guidance; Chi(2) = 56.88, I(2) = 98.2%, P = < 0.00001). We did not pool these data in a meta-analysis. Two studies excluded women who had treatment failure when they calculated the mean time to complete resolution. One study found that the time to complete resolution of breast abscess favoured needle aspiration over I&D (mean difference (MD) -6.07; 95% confidence interval (CI) -7.81 to -4.33; n = 36), but excluded 9/22 (41%) women in the needle aspiration group due to treatment failure. Another study reported faster resolution in the needle aspiration group (MD -17.80; 95% CI -21.27 to -14.33; n = 64) but excluded 6/35 (17%) women in the needle aspiration group due to treatment failure. A third study also reported that needle aspiration was associated with a shorter time to complete resolution of breast abscess (MD -16.00; 95%CI -18.73 to -13.27; n = 60); however, the authors did not indicate the number of women who were lost to follow-up for either group, and it is unclear how many women contributed to this result. Considering the limitations of the available data, we do not consider the results to be informative. Continuation of breastfeeding, after treatment (success): results favoured the needle aspiration group, but we did not pool data from the two studies because of substantial unexplained heterogeneity (I(2) = 97%). One study reported that women in the needle aspiration group were more likely to continue breastfeeding (risk ratio (RR) 2.89; 95% CI 1.64 to 5.08; n = 60), whereas the other study found no clear difference (RR 1.09; 95% CI 0.97 to 1.22 n = 70). Treatment failure was more common among women treated with needle aspiration compared to those who underwent I&D (RR 16.12; 95% CI 2.21 to 117.73; two studies, n = 115, low quality evidence). In one study, treatment with needle aspiration failed in 9/22 women who subsequently underwent I&D to treat their breast abscess. In another study, treatment with needle aspiration failed in 6/35 women, who subsequently underwent I&D. All abscesses in the I&D group were successfully treated.The included studies provided limited data for the review's secondary outcomes. No data were reported for adverse events. One study (60 women) reported that women in the needle aspiration group were more satisfied with their treatment than women who received I&D to treat their breast abscesses. Incision and drainage (I&D) with or without antibioticsOne study (150 women) compared the value of adding a broad-spectrum cephalosporin (single dose or a course of treatment) to women who underwent I&D for breast abscesses.The mean time to resolution of breast abscess was reported as being similar in all groups (although women with infection were excluded). Mean time to resolution for women who received a course of antibiotics was reported as 7.3 days, 6.9 days for women who received a single dose of antibiotics and 7.4 days for women who did not receive antibiotics. Standard deviations, P values and CIs were not reported and prevented further analysis. No data were reported for any continuation of breastfeeding after treatment (success). For treatment failure, there was no clear difference between the groups of women who received antibiotics (either a single dose or a course of antibiotics) and those who did not (RR 1.00; 95% CI 0.36 to 2.76).Included studies rarely reported this review's secondary outcomes (including adverse events). For post-operative complications/morbidity, there was no difference in the risk of wound infections between the antibiotics and no antibiotics groups (RR 0.58; 95% CI 0.29 to 1.17), irrespective of whether women received a single dose or a course of antibiotics. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether needle aspiration is a more effective option to I&D for lactational breast abscesses, or whether an antibiotic should be routinely added to women undergoing I&D for lactational breast abscesses. We graded the evidence for the primary outcome of treatment failure as low quality, with downgrading based on including small studies with few events and unclear risk of bias.


Assuntos
Abscesso/terapia , Doenças Mamárias/terapia , Aleitamento Materno , Abscesso/etiologia , Adulto , Biópsia por Agulha Fina/métodos , Doenças Mamárias/etiologia , Cefalosporinas/uso terapêutico , Drenagem/métodos , Feminino , Humanos , Mastite/etiologia , Mastite/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Falha de Tratamento , Ultrassonografia de Intervenção
6.
Cochrane Database Syst Rev ; 1: CD010767, 2015 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-25582096

RESUMO

BACKGROUND: Anaemia is a global public health problem. Children under five years of age living in developing countries (mostly Africa and South-East Asia) are highly affected. Although the causes for anaemia are multifactorial, malaria has been linked to anaemia in children living in malaria-endemic areas. Administering intermittent preventive antimalarial treatment (IPT) to children might reduce anaemia, since it could protect children from new Plasmodium parasite infection (the parasites that cause malaria) and allow their haemoglobin levels to recover. OBJECTIVES: To assess the effect of IPT for children with anaemia living in malaria-endemic areas. SEARCH METHODS: We searched the Cochrane Infectious Diseases Group Specialized Register, Cochrane Central of Controlled Trials (CENTRAL), published in The Cochrane Library; MEDLINE; EMBASE; and LILACS. We also searched the World Health Organization (WHO) International Clinical Trial Registry Platform and metaRegister of Controlled Trials (mRCT) for ongoing trials up to 4 December 2014. SELECTION CRITERIA: Randomized controlled trials (RCTs) evaluating the effect of IPT on children with anaemia. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias. We analysed data by conducting meta-analyses, stratifying data according to whether participants received iron supplements or not. We used GRADE to assess the quality of evidence. MAIN RESULTS: Six trials with 3847 participants met our inclusion criteria. Trials were conducted in areas of low malaria endemicity (three trials), and moderate to high endemicity (three trials). Four trials were in areas of seasonal malaria transmission. Iron was given to all children in two trials, and evaluated in a factorial design in a further two trials.IPT for children with anaemia probably has little or no effect on the proportion anaemic at 12 weeks follow-up (four trials, 2237 participants, (moderate quality evidence).IPT in anaemic children probably increases the mean change in haemoglobin levels from baseline to follow-up at 12 weeks on average by 0.32 g/dL (MD 0.32, 95% CI 0.19 to 0.45; four trials, 1672 participants, moderate quality evidence); and may improve haemoglobin levels at 12 weeks (MD 0.35, 95% CI 0.06 to 0.64; four trials, 1672 participants, low quality evidence). For both of these outcomes, subgroup analysis did not demonstrate a difference between children receiving iron and those that did not.IPT for children with anaemia probably has little or no effect on mortality or hospital admissions at six months (three trials, 3160 participants moderate quality evidence). Subgroup analysis did not show a difference between those children receiving iron supplements and those that did not. AUTHORS' CONCLUSIONS: Trials did show a small effect on average haemoglobin levels but this did not appear to translate into an effect on mortality and hospital admissions. Three of the six trials were conducted in low endemicity areas where transmission is low and thus any protective effect is likely to be modest.


Assuntos
Anemia/prevenção & controle , Antimaláricos/uso terapêutico , Doenças Endêmicas/prevenção & controle , Malária/prevenção & controle , Anemia/sangue , Anemia/etiologia , Pré-Escolar , Hemoglobina A/metabolismo , Humanos , Lactente , Recém-Nascido , Compostos de Ferro/administração & dosagem , Malária/complicações , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Cochrane Database Syst Rev ; (9): CD010273, 2014 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-25246307

RESUMO

BACKGROUND: Constipation is a functional bowel disorder that can reduce quality of life in the puerperium period. The diagnosis of postpartum constipation is both subjective and objective. It is characterised by symptoms such as pain or discomfort, straining, hard lumpy stools and a sense of incomplete bowel evacuation. Haemorrhoids, pain at the episiotomy site, effects of pregnancy hormones and hematinics used in pregnancy can increase the risk of postpartum constipation. Although a high fibre diet and increased fluid intake is encouraged to assist defecation in the puerperium, pain-relieving drugs and laxatives are common drugs of choice to alleviate constipation. However, the effectiveness and safety of laxatives on the nursing mother need to be ascertained. OBJECTIVES: To evaluate the effectiveness of interventions for treating postpartum constipation. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 March 2014), the metaRegister of Controlled Trials, the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov), the Australian New Zealand Clinical Trials Registry (ANZCTR), the World Health Organization International Clinical Trials Registry platform (ICTRP), the ProQuest database, Stellenbosch University database and Google Scholar (28 March 2014). We also searched the reference lists of potentially relevant studies identified by the search, reviewed articles for relevant trials and contacted experts to identify any additional published or unpublished trials (10 April 2014). SELECTION CRITERIA: All randomised controlled trials comparing any intervention for the treatment of postpartum constipation to another intervention, placebo or no intervention.Interventions could include laxatives, surgery, as well as educational and behavioural interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the results of the search to select potentially relevant studies using pre-designed eligibility inclusion criteria. Discrepancies were resolved through discussion. We did not identify any studies for inclusion. MAIN RESULTS: We did not identify any studies that met our inclusion criteria. We excluded nine studies. AUTHORS' CONCLUSIONS: We could not make explicit conclusions on interventions for treating postpartum constipation because we found no studies for inclusion in this review. Rigorous and well-conducted large randomised controlled trials aimed at treating postpartum women diagnosed with constipation would be beneficial. These trials should also address the criteria for administering the intervention (time and stage of a diagnosis of postpartum constipation), and the safety and effectiveness of such interventions.


Assuntos
Constipação Intestinal/terapia , Período Pós-Parto , Adulto , Feminino , Humanos
8.
Cochrane Database Syst Rev ; (6): CD009243, 2013 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-23737030

RESUMO

BACKGROUND: Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and asphyxia and requires early detection and appropriate clinical response. The risks for complications of prolonged labour are much greater in poor resource settings. Active management of labour versus physiological, expectant management, has shown to decrease the occurrence of prolonged labour. Administering antispasmodics during labour could also lead to faster and more effective dilatation of the cervix. Interventions to shorten labour, such as antispasmodics, can be used as a preventative or a treatment strategy in order to decrease the incidence of prolonged labour. As the evidence to support this is still largely anecdotal around the world, there is a need to systematically review the available evidence to obtain a valid answer. OBJECTIVES: To assess the effects of antispasmodics on labour in term pregnancies. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2013), the ProQuest dissertation and thesis database, the dissertation database of the University of Stellenbosch and Google Scholar (28 February 2013) and reference lists of articles. We also contacted pharmaceutical companies and experts in the field. We did not apply language restrictions. SELECTION CRITERIA: Randomised controlled trials comparing antispasmodics with placebo or no medication in women with term pregnancies. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts and selected studies for inclusion, assessed risk of bias and extracted data. Data were checked for accuracy. We contacted trial authors when data were missing. MAIN RESULTS: Twenty-one trials (n = 3286) were included in the review. Seventeen trials (n = 2617) were included in the meta-analysis. Antispasmodics used included valethamate bromide, hyoscine butyl-bromide, drotaverine hydrochloride, rociverine and camylofin dihydrochloride. Most studies included antispasmodics as part of their package of active management of labour. Overall, the quality of studies was poor, as only four trials were assessed as low risk of bias. Thirteen trials (n = 1995) reported on the duration of first stage of labour, which was significantly reduced by an average of 74.34 minutes when antispasmodics were administered (mean difference (MD) -74.34 minutes; 95% confidence Interval (CI) -98.76 to -49.93). Seven studies (n = 797) reported on the total duration of labour, which was significantly reduced by an average of 85.51 minutes (MD -85.51 minutes; 95% CI -121.81 to -49.20). Six studies (n = 820) had data for the outcome: rate of cervical dilatation. Administration of antispasmodics significantly increased the rate of cervical dilatation by an average of 0.61 cm/hour (MD 0.61 cm/hour; 95% CI 0.34 to 0.88). Antispasmodics did not affect the duration of second and third stage of labour. The rate of normal vertex deliveries was not affected either. Only one study explored pain relief following administration of antispasmodics and no conclusions can be drawn on this outcome. There was significant heterogeneity for most outcomes and therefore, we undertook random-effects meta-analysis. Subgroup analysis was undertaken to explore heterogeneity, but remained largely unexplained. Maternal and neonatal adverse events were reported inconsistently. The main maternal adverse event reported was tachycardia. No serious neonatal adverse events were reported. AUTHORS' CONCLUSIONS: There is low quality evidence that antispasmodics reduce the duration of first stage of labour and increase the cervical dilatation rate. There is very low quality evidence that antispasmodics reduce the total duration of labour. There is moderate quality evidence that antispasmodics do not affect the rate of normal vertex deliveries. There is insufficient evidence to make any conclusions regarding the safety of these drugs for both mother and baby. Large, rigorous randomised controlled trials are needed to evaluate the effect of antispasmodics on prolonged labour and to evaluate their effect on labour in a context of expectant management of labour.


Assuntos
Primeira Fase do Trabalho de Parto/efeitos dos fármacos , Complicações do Trabalho de Parto/tratamento farmacológico , Parassimpatolíticos/uso terapêutico , Feminino , Humanos , Parassimpatolíticos/efeitos adversos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Taquicardia/induzido quimicamente
10.
Cochrane Database Syst Rev ; (8): CD009243, 2012 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-22895986

RESUMO

BACKGROUND: Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and asphyxia and requires early detection and appropriate clinical response. The risks for complications of prolonged labour are much greater in poor resource settings. Active management of labour versus physiological, expectant management, has shown to decrease the occurrence of prolonged labour. Administering antispasmodics during labour could also lead to faster and more effective dilatation of the cervix. Interventions to shorten labour, such as antispasmodics, can be used as a preventative or a treatment strategy in order to decrease the incidence of prolonged labour. As the evidence to support this is still largely anecdotal around the world, there is a need to systematically review the available evidence to obtain a valid answer. OBJECTIVES: To assess the effects of antispasmodics on labour in term pregnancies. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (2 September 2011), the ProQuest dissertation and thesis database, the dissertation database of the University of Stellenbosch (2 September 2011), Google Scholar (2 September 2011) and reference lists of articles. We also contacted pharmaceutical companies and experts in the field. We did not apply language restrictions. SELECTION CRITERIA: Randomised controlled trials comparing antispasmodics with placebo or no medication in women with term pregnancies. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts and selected studies for inclusion, assessed risk of bias and extracted data. Data were checked for accuracy. We contacted trial authors when data were missing. MAIN RESULTS: Nineteen trials (n = 2798) were included in the review. Fifteen trials (n = 2129) were included in the meta-analysis. Antispasmodics used included valethamate bromide, hyoscine butyl-bromide, drotaverine hydrochloride, rociverine and camylofin dihydrochloride. Most studies included antispasmodics as part of their package of active management of labour. Overall, the quality of studies was poor, as only four trials were assessed as low risk of bias. Eleven trials (n = 1507) reported on the duration of first stage of labour, which was significantly reduced by an average of 65.80 minutes when antispasmodics were administered (mean difference (MD) -65.80 minutes; 95% confidence Interval (CI) -92.32 to -39.28). Seven studies (n = 797) reported on the total duration of labour, which was significantly reduced by an average of 85.51 minutes (MD -85.51 minutes; 95% CI -121.81 to -49.20). Five studies (n = 632) had data for the outcome: rate of cervical dilatation. Administration of antispasmodics significantly increased the rate of cervical dilatation by an average of 0.55 cm/h (MD 0.55 cm/h; 95% CI 0.22 to 0.87). Antispasmodics did not affect the duration of second and third stage of labour. The rate of normal vertex deliveries was not affected either. Only one study explored pain relief following administration of antispasmodics and no conclusions can be drawn on this outcome. There was significant heterogeneity for most outcomes and therefore, we undertook random-effects meta-analysis. Subgroup analysis was undertaken to explore heterogeneity, but remained largely unexplained. Maternal and neonatal adverse events were reported inconsistently. The main maternal adverse event reported was tachycardia. No serious neonatal adverse events were reported. AUTHORS' CONCLUSIONS: There is low quality evidence that antispasmodics reduce the duration of first stage of labour and increase the cervical dilatation rate. There is very low quality evidence that antispasmodics reduce the total duration of labour. There is moderate quality evidence that antispasmodics do not affect the rate of normal vertex deliveries. There is insufficient evidence to make any conclusions regarding the safety of these drugs for both mother and baby. Large, rigorous randomised controlled trials are needed to evaluate the effect of antispasmodics on prolonged labour and to evaluate their effect on labour in a context of expectant management of labour.


Assuntos
Trabalho de Parto/efeitos dos fármacos , Parassimpatolíticos/uso terapêutico , Feminino , Humanos , Primeira Fase do Trabalho de Parto/efeitos dos fármacos , Complicações do Trabalho de Parto/prevenção & controle , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo
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