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1.
Cochrane Database Syst Rev ; 3: CD001337, 2021 03 11.
Artigo em Inglês | MEDLINE | ID: mdl-33705565

RESUMO

BACKGROUND: Retained placenta is a common complication of pregnancy affecting 1% to 6% of all births. If a retained placenta is left untreated, spontaneous delivery of the placenta may occur, but there is a high risk of bleeding and infection. Manual removal of the placenta (MROP) in an operating theatre under anaesthetic is the usual treatment, but is invasive and may have complications. An effective non-surgical alternative for retained placenta would potentially reduce the physical and psychological trauma of the procedure, and costs. It could also be lifesaving by providing a therapy for settings without easy access to modern operating theatres or anaesthetics. Injection of uterotonics into the uterus via the umbilical vein and placenta is an attractive low-cost option for this. This is an update of a review last published in 2011. OBJECTIVES: To assess the use of umbilical vein injection (UVI) of saline solution with or without uterotonics compared to either expectant management or with an alternative solution or other uterotonic agent for retained placenta. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (14 June 2020), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing UVI of saline or other fluids (with or without uterotonics), either with expectant management or with an alternative solution or other uterotonic agent, in the management of retained placenta. We considered quasi-randomised, cluster-randomised, and trials reported only in abstract form. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. We assessed the certainty of the evidence using the GRADE approach. We calculated pooled risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs), and presented results using 'Summary of findings' tables. MAIN RESULTS: We included 24 trials (n = 2348). All included trials were RCTs, one was quasi-randomised, and none were cluster-randomised. Risk of bias was variable across the included studies. We assessed certainty of evidence for four comparisons: saline versus expectant management, oxytocin versus expectant management, oxytocin versus saline, and oxytocin versus plasma expander. Evidence was moderate to very-low certainty and downgraded for risk of bias of included studies, imprecision, and inconsistency of effect estimates. Saline solution versus expectant management There is probably little or no difference in the incidence of MROP between saline and expectant management (RR 0.93, 95% CI 0.80 to 1.10; 5 studies, n = 445; moderate-certainty evidence). Evidence for the following remaining primary outcomes was very-low certainty: severe postpartum haemorrhage 1000 mL or greater, blood transfusion, and infection. There were no events reported for maternal mortality or postpartum anaemia (24 to 48 hours postnatal). No studies reported addition of therapeutic uterotonics. Oxytocin solution versus expectant management UVI of oxytocin solution might slightly reduce in the need for manual removal compared with expectant management (mean RR 0.73, 95% CI 0.56 to 0.95; 7 studies, n = 546; low-certainty evidence). There may be little to no difference between the incidence of blood transfusion between groups (RR 0.81, 95% CI 0.47 to 1.38; 4 studies, n = 339; low-certainty evidence). There were no maternal deaths reported (2 studies, n = 93). Evidence for severe postpartum haemorrhage of 1000 mL or greater, additional uterotonics, and infection was very-low certainty. There were no events for postpartum anaemia (24 to 48 hours postnatal). Oxytocin solution versus saline solution UVI of oxytocin solution may reduce the use of MROP compared with saline solution, but there was high heterogeneity (RR 0.82, 95% CI 0.69 to 0.97; 14 studies, n = 1370; I² = 54%; low-certainty evidence). There were no differences between subgroups according to risk of bias or oxytocin dose for the outcome MROP. There may be little to no difference between groups in severe postpartum haemorrhage of 1000 mL or greater, blood transfusion, use of additional therapeutic uterotonics, and antibiotic use. There were no events for postpartum anaemia (24 to 48 hours postnatal) (very low-certainty evidence) and there was only one event for maternal mortality (low-certainty evidence). Oxytocin solution versus plasma expander One small study reported UVI of oxytocin compared with plasma expander (n = 109). The evidence was very unclear about any effect on MROP or blood transfusion between the two groups (very low-certainty evidence). No other primary outcomes were reported. For other comparisons there were little to no differences for most outcomes examined. However, there was some evidence to suggest that there may be a reduction in MROP with prostaglandins in comparison to oxytocin (4 studies, n = 173) and ergometrine (1 study, n = 52), although further large-scale studies are needed to confirm these findings. AUTHORS' CONCLUSIONS: UVI of oxytocin solution is an inexpensive and simple intervention that can be performed when placental delivery is delayed. This review identified low-certainty evidence that oxytocin solution may slightly reduce the need for manual removal. However, there are little or no differences for other outcomes. Small studies examining injection of prostaglandin (such as dissolved misoprostol) into the umbilical vein show promise and deserve to be studied further.

2.
PLoS One ; 16(2): e0245989, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33561141

RESUMO

INTRODUCTION: Oral bicarbonate solution is known to improve both maternal and perinatal outcomes among women with abnormal labour (dystocia). Its effectiveness and safety among women with obstructed labour is not known. OBJECTIVE: To determine the effect and safety of a single-dose preoperative infusion of sodium bicarbonate on maternal and fetal blood lactate and clinical outcomes among women with obstructed labour (OL) in Mbale hospital. METHODS: We conducted a double blind, randomised controlled trial from July 2018 to September 2019. The participants were women with OL at term (≥37 weeks gestation), carrying a singleton pregnancy with no other obstetric emergency, medical comorbidity or laboratory derangements. INTERVENTION: A total of 477 women with OL were randomized to receive 50ml of 8.4% sodium bicarbonate (238 women) or 50 mL of 0.9% sodium chloride (239 women). In both the intervention and controls arms, each participant was preoperatively given a single dose intravenous bolus. Every participant received 1.5 L of normal saline in one hour as part of standard preoperative care. OUTCOME MEASURES: Our primary outcome was the mean difference in maternal venous blood lactate at one hour between the two arms. The secondary outcomes were umbilical cord blood lactate levels at birth, neonatal sepsis and early neonatal death upto 7 days postnatal, as well as the side effects of sodium bicarbonate, primary postpartum hemorrhage, maternal sepsis and mortality at 14 days postpartum. RESULTS: The median maternal venous lactate was 6.4 (IQR 3.3-12.3) in the intervention and 7.5 (IQR 4.0-15.8) in the control group, with a statistically non-significant median difference of 1.2 mmol/L; p-value = 0.087. Vargha and Delaney effect size was 0.46 (95% CI 0.40-0.51) implying very little if any effect at all. CONCLUSION: The 4.2g of preoperative intravenous sodium bicarbonate was safe but made little or no difference on blood lactate levels. TRIAL REGISTRATION: PACTR201805003364421.

3.
Cochrane Database Syst Rev ; 11: CD012754, 2020 11 24.
Artigo em Inglês | MEDLINE | ID: mdl-33232518

RESUMO

BACKGROUND: Postpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more after birth, is the leading cause of maternal death worldwide. The World Health Organization (WHO) recommends that all women giving birth should receive a prophylactic uterotonic agent. Despite the routine administration of a uterotonic agent for prevention, PPH remains a common complication causing one-quarter of all maternal deaths globally. When prevention fails and PPH occurs, further administration of uterotonic agents as 'first-line' treatment is recommended. However, there is uncertainty about which uterotonic agent is best for the 'first-line' treatment of PPH. OBJECTIVES: To identify the most effective uterotonic agent(s) with the least side-effects for PPH treatment, and generate a meaningful ranking among all available agents according to their relative effectiveness and side-effect profile. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 May 2020), and the reference lists of all retrieved studies. SELECTION CRITERIA: All randomised controlled trials or cluster-randomised trials comparing the effectiveness and safety of uterotonic agents with other uterotonic agents for the treatment of PPH were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed all trials for inclusion, extracted data and assessed each trial for risk of bias. Our primary outcomes were additional blood loss of 500 mL or more after recruitment to the trial until cessation of active bleeding and the composite outcome of maternal death or severe morbidity. Secondary outcomes included blood loss-related outcomes, morbidity outcomes, and patient-reported outcomes. We performed pairwise meta-analyses and indirect comparisons, where possible, but due to the limited number of included studies, we were unable to conduct the planned network meta-analysis. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: Seven trials, involving 3738 women in 10 countries, were included in this review. All trials were conducted in hospital settings. Randomised women gave birth vaginally, except in one small trial, where women gave birth either vaginally or by caesarean section. Across the seven trials (14 trial arms) the following agents were used: six trial arms used oxytocin alone; four trial arms used misoprostol plus oxytocin; three trial arms used misoprostol; one trial arm used Syntometrine® (oxytocin and ergometrine fixed-dose combination) plus oxytocin infusion. Pairwise meta-analysis of two trials (1787 participants), suggests that misoprostol, as first-line treatment uterotonic agent, probably increases the risk of blood transfusion (risk ratio (RR) 1.47, 95% confidence interval (CI) 1.02 to 2.14, moderate-certainty) compared with oxytocin. Low-certainty evidence suggests that misoprostol administration may increase the incidence of additional blood loss of 1000 mL or more (RR 2.57, 95% CI 1.00 to 6.64). The data comparing misoprostol with oxytocin is imprecise, with a wide range of treatment effects for the additional blood loss of 500 mL or more (RR 1.66, 95% CI 0.69 to 4.02, low-certainty), maternal death or severe morbidity (RR 1.98, 95% CI 0.36 to 10.72, low-certainty, based on one study n = 809 participants, as the second study had zero events), and the use of additional uterotonics (RR 1.30, 95% CI 0.57 to 2.94, low-certainty). The risk of side-effects may be increased with the use of misoprostol compared with oxytocin: vomiting (2 trials, 1787 participants, RR 2.47, 95% CI 1.37 to 4.47, high-certainty) and fever (2 trials, 1787 participants, RR 3.43, 95% CI 0.65 to 18.18, low-certainty). According to pairwise meta-analysis of four trials (1881 participants) generating high-certainty evidence, misoprostol plus oxytocin makes little or no difference to the use of additional uterotonics (RR 0.99, 95% CI 0.94 to 1.05) and to blood transfusion (RR 0.95, 95% CI 0.77 to 1.17) compared with oxytocin. We cannot rule out an important benefit of using the misoprostol plus oxytocin combination over oxytocin alone, for additional blood loss of 500 mL or more (RR 0.84, 95% CI 0.66 to 1.06, moderate-certainty). We also cannot rule out important benefits or harms for additional blood loss of 1000 mL or more (RR 0.76, 95% CI 0.43 to 1.34, moderate-certainty, 3 trials, 1814 participants, one study reported zero events), and maternal mortality or severe morbidity (RR 1.09, 95% CI 0.35 to 3.39, moderate-certainty). Misoprostol plus oxytocin increases the incidence of fever (4 trials, 1866 participants, RR 3.07, 95% CI 2.62 to 3.61, high-certainty), and vomiting (2 trials, 1482 participants, RR 1.85, 95% CI 1.16 to 2.95, high-certainty) compared with oxytocin alone. For all outcomes of interest, the available evidence on the misoprostol versus Syntometrine® plus oxytocin combination was of very low-certainty and these effects remain unclear. Although network meta-analysis was not performed, we were able to compare the misoprostol plus oxytocin combination with misoprostol alone through the common comparator of oxytocin. This indirect comparison suggests that the misoprostol plus oxytocin combination probably reduces the risk of blood transfusion (RR 0.65, 95% CI 0.42 to 0.99, moderate-certainty) and may reduce the risk of additional blood loss of 1000 mL or more (RR 0.30, 95% CI 0.10 to 0.89, low-certainty) compared with misoprostol alone. The combination makes little or no difference to vomiting (RR 0.75, 95% CI 0.35 to 1.59, high-certainty) compared with misoprostol alone. Misoprostol plus oxytocin compared to misoprostol alone are compatible with a wide range of treatment effects for additional blood loss of 500 mL or more (RR 0.51, 95% CI 0.20 to 1.26, low-certainty), maternal mortality or severe morbidity (RR 0.55, 95% CI 0.07 to 4.24, low-certainty), use of additional uterotonics (RR 0.76, 95% CI 0.33 to 1.73, low-certainty), and fever (RR 0.90, 95% CI 0.17 to 4.77, low-certainty). AUTHORS' CONCLUSIONS: The available evidence suggests that oxytocin used as first-line treatment of PPH probably is more effective than misoprostol with less side-effects. Adding misoprostol to the conventional treatment of oxytocin probably makes little or no difference to effectiveness outcomes, and is also associated with more side-effects. The evidence for most uterotonic agents used as first-line treatment of PPH is limited, with no evidence found for commonly used agents, such as injectable prostaglandins, ergometrine, and Syntometrine®.

4.
Sci Transl Med ; 12(563)2020 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-32998967

RESUMO

Postinfectious hydrocephalus (PIH), which often follows neonatal sepsis, is the most common cause of pediatric hydrocephalus worldwide, yet the microbial pathogens underlying this disease remain to be elucidated. Characterization of the microbial agents causing PIH would enable a shift from surgical palliation of cerebrospinal fluid (CSF) accumulation to prevention of the disease. Here, we examined blood and CSF samples collected from 100 consecutive infant cases of PIH and control cases comprising infants with non-postinfectious hydrocephalus in Uganda. Genomic sequencing of samples was undertaken to test for bacterial, fungal, and parasitic DNA; DNA and RNA sequencing was used to identify viruses; and bacterial culture recovery was used to identify potential causative organisms. We found that infection with the bacterium Paenibacillus, together with frequent cytomegalovirus (CMV) coinfection, was associated with PIH in our infant cohort. Assembly of the genome of a facultative anaerobic bacterial isolate recovered from cultures of CSF samples from PIH cases identified a strain of Paenibacillus thiaminolyticus This strain, designated Mbale, was lethal when injected into mice in contrast to the benign reference Paenibacillus strain. These findings show that an unbiased pan-microbial approach enabled characterization of Paenibacillus in CSF samples from PIH cases, and point toward a pathway of more optimal treatment and prevention for PIH and other proximate neonatal infections.

5.
Res Involv Engagem ; 6: 57, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32974053

RESUMO

Background: Maternal and newborn deaths and ill health are relatively common in low income countries, but can adequately be addressed through locally, collaboratively designed, and responsive research. This has the potential to enable the affected women, their families and health workers themselves to explore 'why maternal and newborn adverse outcomes continue to occur. The objectives of the study include; To work with seldom heard groups of mothers, their families, and health workers to identify unanswered research questions for maternal and newborn health in villages and health facilities in rural UgandaTo establish locally responsive research questions for maternal and newborn health that could be prioritised together with the public in UgandaTo support the case for locally responsive research in maternal and newborn health by the ministry of health, academic researchers and funding bodies in Uganda. Methods: The present study will follow the James Lind Alliance (JLA) Priority Setting Partnership (PSP) methodology. The project was initiated by an academic research group and will be managed by a research team at the Sanyu Africa Research Institute on a day to day basis. A steering group with a separate lay mothers' group and partners' group (individuals or organisations with interest in maternal and newborn health) will be recruited. The PSP will be initiated by launch meetings, then a face-to-face initial survey for the collection of raw unanswered questions; followed by data collation. A face-to-face interim prioritisation survey will then be performed to choose questions before the three separate final prioritisation workshops.The PSP will involve many participants from an illiterate, non-internet population in rural eastern Uganda, but all with an interest in strategies to avert maternal and newborn deaths or morbidities in rural eastern Uganda. This includes local rural women, their families, health and social workers, and relevant local groups or organisations.We will generate a top 10 list of maternal and newborn health research priorities from a group with no prior experience in setting a research agenda in rural eastern Uganda. Discussion: The current protocol elaborates the JLA methods for application with a new topic and in a new setting translating the JLA principles not just into the local language, but into a rural, vulnerable, illiterate, and non-internet population in Uganda. The face-to-face human interaction is powerful in eliciting what exactly matters to individuals in this particular context as opposed to online surveys.This will be the first time that mothers and lay public with current or previous experience of maternal or neonatal adverse outcomes will have the opportunity to identify and prioritise research questions that matter to them in Uganda. We will be able to compare how the public would prioritise maternal health research questions over newborn health in this setting.

6.
Cochrane Database Syst Rev ; 7: CD013663, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32609374

RESUMO

BACKGROUND: Primary postpartum haemorrhage (PPH) is commonly defined as bleeding from the genital tract of 500 mL or more within 24 hours of birth. It is one of the most common causes of maternal mortality worldwide and causes significant physical and psychological morbidity. An earlier Cochrane Review considering any treatments for the management of primary PPH, has been split into separate reviews. This review considers treatment with mechanical and surgical interventions. OBJECTIVES: To determine the effectiveness and safety of mechanical and surgical interventions used for the treatment of primary PPH. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (26 July 2019) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) of mechanical/surgical methods for the treatment of primary PPH compared with standard care or another mechanical/surgical method. Interventions could include uterine packing, intrauterine balloon insertion, artery ligation/embolism, or uterine compression (either with sutures or manually). We included studies reported in abstract form if there was sufficient information to permit risk of bias assessment. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion and risk of bias, independently extracted data and checked data for accuracy. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included nine small trials (944 women) conducted in Pakistan, Turkey, Thailand, Egypt (four trials), Saudi Arabia, Benin and Mali. Overall, included trials were at an unclear risk of bias. Due to substantial differences between the studies, it was not possible to combine any trials in meta-analysis. Many of this review's important outcomes were not reported. GRADE assessments ranged from very low to low, with the majority of outcome results rated as very low certainty. Downgrading decisions were mainly based on study design limitations and imprecision; one study was also downgraded for indirectness. External uterine compression versus normal care (1 trial, 64 women) Very low-certainty evidence means that we are unclear about the effect on blood transfusion (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.66 to 8.23). Uterine arterial embolisation versus surgical devascularisation plus B-Lynch (1 trial, 23 women) The available evidence for hysterectomy to control bleeding (RR 0.73, 95% CI 0.15 to 3.57) is unclear due to very low-certainty evidence. The available evidence for intervention side effects is also unclear because the evidence was very low certainty (RR 1.09; 95% CI 0.08 to 15.41). Intrauterine Tamponade Studies included various methods of intrauterine tamponade: the commercial Bakri balloon, a fluid-filled condom-loaded latex catheter ('condom catheter'), an air-filled latex balloon-loaded catheter ('latex balloon catheter'), or traditional packing with gauze. Balloon tamponade versus normal care (2 trials, 356 women) One study(116 women) used the condom catheter. This study found that it may increase blood loss of 1000 mL or more (RR 1.52, 95% CI 1.15 to 2.00; 113 women), very low-certainty evidence. For other outcomes the results are unclear and graded as very low-certainty evidence: mortality due to bleeding (RR 6.21, 95% CI 0.77 to 49.98); hysterectomy to control bleeding (RR 4.14, 95% CI 0.48 to 35.93); total blood transfusion (RR 1.49, 95% CI 0.88 to 2.51); and side effects. A second study of 240 women used the latex balloon catheter together with cervical cerclage. Very low-certainty evidence means we are unclear about the effect on hysterectomy (RR 0.14, 95% CI 0.01 to 2.74) and additional surgical interventions to control bleeding (RR 0.20, 95% CI 0.01 to 4.12). Bakri balloon tamponade versus haemostatic square suturing of the uterus (1 trial, 13 women) In this small trial there was no mortality due to bleeding, serious maternal morbidity or side effects of the intervention, and the results are unclear for blood transfusion (RR 0.57, 95% CI 0.14 to 2.36; very low certainty). Bakri balloon tamponade may reduce mean 'intraoperative' blood loss (mean difference (MD) -426 mL, 95% CI -631.28 to -220.72), very low-certainty evidence. Comparison of intrauterine tamponade methods (3 trials, 328 women) One study (66 women) compared the Bakri balloon and the condom catheter, but it was uncertain whether the Bakri balloon reduces the risk of hysterectomy to control bleeding due to very low-certainty evidence (RR 0.50, 95% CI 0.05 to 5.25). Very low-certainty evidence also means we are unclear about the results for the risk of blood transfusion (RR 0.97, 95% CI 0.88 to 1.06). A second study (50 women) compared Bakri balloon, with and without a traction stitch. Very low-certainty evidence means we are unclear about the results for hysterectomy to control bleeding (RR 0.20, 95% CI 0.01 to 3.97). A third study (212 women) compared the condom catheter to gauze packing and found that it may reduce fever (RR 0.47, 95% CI 0.38 to 0.59), but again the evidence was very low certainty. Modified B-Lynch compression suture versus standard B-Lynch compression suture (1 trial, 160 women) Low-certainty evidence suggests that a modified B-Lynch compression suture may reduce the risk of hysterectomy to control bleeding (RR 0.33, 95% CI 0.11 to 0.99) and postoperative blood loss (MD -244.00 mL, 95% CI -295.25 to -192.75). AUTHORS' CONCLUSIONS: There is currently insufficient evidence from RCTs to determine the relative effectiveness and safety of mechanical and surgical interventions for treating primary PPH. High-quality randomised trials are urgently needed, and new emergency consent pathways should facilitate recruitment. The finding that intrauterine tamponade may increase total blood loss > 1000 mL suggests that introducing condom-balloon tamponade into low-resource settings on its own without multi-system quality improvement does not reduce PPH deaths or morbidity. The suggestion that modified B-Lynch suture may be superior to the original requires further research before the revised technique is adopted. In high-resource settings, uterine artery embolisation has become popular as the equipment and skills become more widely available. However, there is little randomised trial evidence regarding efficacy and this requires further research. We urge new trial authors to adopt PPH core outcomes to facilitate consistency between primary studies and subsequent meta-analysis.


Assuntos
Hemorragia Pós-Parto/terapia , Viés , Transfusão de Sangue/estatística & dados numéricos , Feminino , Hemostasia Cirúrgica/métodos , Técnicas Hemostáticas , Humanos , Histerectomia/métodos , Pressão , Ensaios Clínicos Controlados Aleatórios como Assunto , Técnicas de Sutura , Embolização da Artéria Uterina , Tamponamento com Balão Uterino/métodos
7.
Artigo em Inglês | MEDLINE | ID: mdl-32402601

RESUMO

The physiology of the third stage of labour is described. Active management reduces the risk of postpartum haemorrhage (PPH), due to the use of a uterotonic agent. Intramuscular Oxytocin 10 IU has the highest efficacy and lowest side effect profile, although ergometrine, carbetocin and misoprostol are also effective. The appropriate uterotonic in different settings such as home birth by unskilled attendants and at caesarean section is discussed. For the latter, there is less consensus on the optimal dose/route of oxytocin, this topic remaining on the research agenda. Delayed cord clamping enables transfusion of blood to the neonate and is recommended rather than early clamping. Controlled cord traction should only be performed by skilled birth attendants and confers minimal advantage in preventing retained placenta. The importance of early recognition of PPH, and preparedness, is emphasised. An approach to medical and surgical management of PPH is presented.


Assuntos
Terceira Fase do Trabalho de Parto/fisiologia , Tocologia , Placenta Retida/prevenção & controle , Hemorragia Pós-Parto/prevenção & controle , Cesárea , Ergonovina/administração & dosagem , Feminino , Humanos , Recém-Nascido , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Ocitocina/administração & dosagem , Gravidez
8.
Surg Infect (Larchmt) ; 21(6): 540-546, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32196425

RESUMO

Background: Prolonged surgical antimicrobial prophylaxis (SAP) to prevent surgical site infection (SSI) is generally discouraged after completion of surgery. However, little is known about the pattern of peri-operative antibiotic use in resource-limited settings. We aimed to describe its use at a typical government hospital in Uganda. Methods: A study was originally conducted in a rural Ugandan regional referral and teaching hospital in 2014 and 2015 to improve hand hygiene practice and measure its impact on health-care-associated infections including SSI (WardGel study). This is a secondary analysis of the data from the WardGel study to assess the frequency of peri-operative antibiotic use among surgical patients. Results: Of 3,627 patients enrolled into the original study, 960 (26.5%) underwent surgery at the hospital and 907 patients (94.5%) received antibiotic agents during hospitalization. Of these, 880 patients (97.0%, of 907 patients) received antibiotic agents on the day of surgery. A combination of ceftriaxone and metronidazole was the most common regimen (609/907 patients, 67.1%). Thirty-six of 907 patients (4.0%) started and completed their antibiotic agents on the day of surgery. The mean length of antibiotic use during hospitalization was 3.5 days (standard deviation, 3.3). After adjusting for covariates, linear regression analysis showed an extra 1.9 days of antibiotic use post-operatively (95% confidence interval = 1.7-2.3). During the total 4,960 inpatient-days for those having surgery, there were 6,503 days of therapy (DOTs) of antibiotic agents and 1,649 antibiotic-free days (AFDs). Conclusions: Most patients received prolonged antibiotic therapy after surgery. Antimicrobial stewardship for SAP can play a major role in combating antimicrobial resistance in resource-limited settings.

11.
Lancet Glob Health ; 7(9): e1280-e1286, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31402008

RESUMO

BACKGROUND: There is ongoing debate on the clinical benefits of antibiotic prophylaxis for reducing pelvic infection after miscarriage surgery. We aimed to study the cost-effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in low-income countries. METHODS: We did an incremental cost-effectiveness analysis using data from 3412 women recruited to the AIMS trial, a randomised, double-blind, placebo-controlled trial designed to evaluate the effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in Malawi, Pakistan, Tanzania, and Uganda. Economic evaluation was done from a health-care-provider perspective on the basis of the outcome of cost per pelvic infection avoided within 2 weeks of surgery. Pelvic infection was broadly defined by the presence of clinical features or the clinically identified need to administer antibiotics. We used non-parametric bootstrapping and multilevel random effects models to estimate incremental mean costs and outcomes. Decision uncertainty was shown via cost-effectiveness acceptability frontiers. The AIMS trial is registered with the ISRCTN registry, number ISRCTN97143849. FINDINGS: Between June 2, 2014, and April 26, 2017, 3412 women were assigned to receive either antibiotic prophylaxis (1705 [50%] of 3412) or placebo (1707 [50%] of 3412) in the AIMS trial. 158 (5%) of 3412 women developed pelvic infection within 2 weeks of surgery, of whom 68 (43%) were in the antibiotic prophylaxis group and 90 (57%) in the placebo group. There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided. In terms of post-surgery antibiotics, the antibiotic prophylaxis group was US$0·27 (95% CI -0·49 to -0·05) less expensive per woman than the placebo group. A secondary analysis, a sensitivity analysis, and all subgroup analyses supported these findings. Antibiotic prophylaxis, if implemented routinely before miscarriage surgery, could translate to an annual total cost saving of up to $1·4 million across the four participating countries and up to $8·5 million across the two regions of sub-Saharan Africa and south Asia. INTERPRETATION: Antibiotic prophylaxis is more effective and less expensive than no antibiotic prophylaxis. Policy makers in various settings should be confident that antibiotic prophylaxis in miscarriage surgery is cost-effective. FUNDING: UK Medical Research Council, Wellcome Trust, and the UK Department for International Development.


Assuntos
Aborto Espontâneo/cirurgia , Antibioticoprofilaxia/economia , Adolescente , Adulto , Análise Custo-Benefício , Países em Desenvolvimento , Método Duplo-Cego , Feminino , Humanos , Malaui , Paquistão , Gravidez , Tanzânia , Resultado do Tratamento , Uganda , Adulto Jovem
12.
Afr J Reprod Health ; 23(2): 76-91, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31433596

RESUMO

The psychological burdens that patients experience while undergoing treatment for infertility in both men and women are well known and documented, especially within African populations. There are not many tested practical solutions to the problem, and clinical personnel have little time for personal counselling. This article described the development and delivery of an intervention designed to manage the psychological trauma that patients experience while dealing with infertility in resource poor settings. The Fertility Life Counselling Aid (FELICIA) has been developed to manage the psychological morbidity associated with infertility using cognitive behavioural therapy (CBT) based strategies. FELICIA provides a structured step by step guide to infertility counselling and is designed to be used by general community or hospital health workers rather than specialist psychologists or psychiatrists. This should make it a cost-effective option to deliver holistic care to patients treated for infertility, especially in resource poor settings.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Infertilidade/psicologia , Trauma Psicológico/terapia , Adulto , Aconselhamento , Feminino , Humanos , Masculino , Saúde Mental , Trauma Psicológico/etiologia , Trauma Psicológico/psicologia
13.
Artigo em Inglês | MEDLINE | ID: mdl-31235396

RESUMO

Postpartum haemorrhage is a major global cause of mortality and morbidity amongst childbearing women. Failure or delay in recognising the severity of bleeding is an important contributory factor in these outcomes. Earlier recognition of haemorrhage would facilitate earlier intervention and treatment, helping resolve the causes of bleeding sooner, and thereby improving outcomes for women. Ways to achieve earlier recognition have traditionally focussed on the clinical skill of assessing the volume of blood loss. However, despite extensive research, the optimum method of assessing blood loss and achieving earlier diagnosis remains unclear. Examination of the psychological literature suggests that clinical decision-making is more complex and highlights some of the reasons why traditional approaches have had a limited effect. Using psychological theories of decision-making to inform solutions may lead to more successful strategies to address the issues than the current focus on volume assessment of blood loss.


Assuntos
Hemorragia Pós-Parto , Feminino , Humanos , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/etiologia , Hemorragia Pós-Parto/terapia , Gravidez
14.
Artigo em Inglês | MEDLINE | ID: mdl-31204091

RESUMO

Post-partum haemorrhage (PPH) is a major pathological condition leading to mortality of women worldwide. Its initial treatment has largely been focused on uterotonics. This paper examines the use of histograms to assess the efficacy of uterotonic treatment for PPH. Previous examinations of large datasets in which women were treated at 700 ml of measured blood loss according to strict protocols have shown a quantifiable peak in the histogram at 700-800 ml following treatment. It is not clear whether this is commonly seen in other studies. The main aim was therefore to assess whether post-treatment peaks are routinely seen in postpartum blood loss histograms and whether the peaks are seen only in treated women. Four datasets of more than 1000 women with measured blood loss were identified and the original data examined. The secondary peak was not only seen in histograms attributed to treatment, but also many of the histograms where women had not received uterotonic treatment. Many women received treatment despite having blood loss of less than 500 ml, and many women who stopped bleeding with final blood losses of more than 500 ml did not receive any uterotonics. The routine use of histogram analysis to assess the efficiency of uterotonic therapy is not recommended. The paper also provides further insights into clinical practice, with clinicians frequently using uterotonic therapies even when the volume of the blood loss is low. This demonstrates how uterotonic use in practice is often not linked to the standard 500 ml definition of post-partum haemorrhage.


Assuntos
Ocitócicos , Hemorragia Pós-Parto , Útero , Estudos de Viabilidade , Feminino , Humanos , Ocitócicos/uso terapêutico , Hemorragia Pós-Parto/tratamento farmacológico , Período Pós-Parto , Gravidez , Útero/fisiopatologia
17.
BMC Res Notes ; 10(1): 516, 2017 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-29073923

RESUMO

BACKGROUND: Advance provision of misoprostol to women during antenatal care aims to achieve broader access to uterotonics for the prevention of postpartum hemorrhage. Studies of this community-based approach usually involve antenatal education as well as timely postpartum follow-up visits to confirm maternal and neonatal outcomes. The MamaMiso study in Mbale, Uganda sought to assess the feasibility of conducting follow-up visits in the postpartum period following advance provision of misoprostol for postpartum hemorrhage prevention. MamaMiso recruited women during antenatal care visits. Participants were asked to contact the research team within 48 h of giving birth so that postpartum follow-up visits could be carried out at their homes. Women's baseline and delivery characteristics were collected and analyzed with respect to follow-up time ('on time' ≤ 7 days, 'late' > 7 days, and 'lost to follow up'). Every woman who was followed up late due to a failure to report the delivery was asked for the underlying reasons for the delay. When attempts at following up participants were unsuccessful, a file note was generated explaining the details of the failure. We abstracted data and identified themes from these notes. RESULTS: Of 748 recruited women, 700 (94%) were successfully followed up during the study period, 465 (62%) within the first week postpartum. The median time to follow up was 4 days and was similar for women who delivered at home or in facilities and for women who had attended or unattended births. Women recruited at the urban hospital site (as opposed to rural health clinics) were more likely to be lost to follow up or followed up late. Of the women followed up late, 202 provided a reason. File notes explaining failed attempts at follow up were generated for 164 participants. Several themes emerged from qualitative analysis of these notes including phone difficulties, inaccurate baseline information, misperceptions, postpartum travel, and the condition of the mother and neonate. CONCLUSIONS: Keeping women connected to the health system in the postpartum period is feasible, though reaching them within the first week of their delivery is challenging. Understanding characteristics of women who are harder to reach can help tailor follow-up efforts and elucidate possible biases in postpartum study data. Trial Registration Number ISRCTN70408620 December 28, 2011.


Assuntos
Assistência ao Convalescente/estatística & dados numéricos , Serviços de Saúde Comunitária/estatística & dados numéricos , Parto Domiciliar/estatística & dados numéricos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Assistência Perinatal/estatística & dados numéricos , Hemorragia Pós-Parto/prevenção & controle , Cuidado Pré-Natal/estatística & dados numéricos , Adulto , Assistência ao Convalescente/normas , Serviços de Saúde Comunitária/normas , Feminino , Humanos , Assistência Perinatal/normas , Período Pós-Parto , Uganda , Adulto Jovem
19.
Lancet ; 390(10095): 669-680, 2017 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-28668289

RESUMO

BACKGROUND: Between 62 000 and 77 000 women die annually from pre-eclampsia and eclampsia. Prompt delivery, preferably by the vaginal route, is vital for good maternal and neonatal outcomes. Two low-cost interventions-low-dose oral misoprostol tablets and transcervical Foley catheterisation-are already used in low-resource settings. We aimed to compare the relative risks and benefits of these interventions. METHODS: We undertook this multicentre, open-label, randomised controlled trial in two public hospitals in Nagpur, India. Women (aged ≥18 years) who were at 20 weeks' gestation or later with a live fetus and required delivery as a result of pre-eclampsia or hypertension were randomly assigned (1:1), via computer-generated block randomisation (block sizes of four, six, and eight) with concealment by use of opaque, sequentially numbered, sealed envelopes, to receive labour induction with either oral misoprostol 25 µg every 2 h (maximum of 12 doses) or a transcervical Foley catheter (silicone, size 18 F with 30 mL balloon). Randomisation was stratified by study centre. The catheter remained in place until active labour started, the catheter fell out, or 12 h had elapsed. If the catheter did not fall out within 12 h, induction continued with artificial membrane rupture and oxytocin, administered through a micro-drip gravity infusion set. Fetal monitoring was by intermittent auscultation. The primary outcome was vaginal birth within 24 h. Due to the nature of the interventions, masking of participants, study investigators, and care providers to group allocation was not possible. We analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01801410. FINDINGS: Between Dec 20, 2013, and June 29, 2015, we randomly assigned 602 women to induction with misoprostol (n=302) or the Foley catheter (n=300; intention-to-treat population). Vaginal birth within 24 h was more common in women in the misoprostol group than in the Foley catheter group (172 [57·0%] vs 141 [47·0%] women; absolute risk difference 10·0%, 95% CI 2·0-17·9; p=0·0136). Rates of uterine hyperstimulation were low in both the misoprostol and Foley catheter groups (two [0·7%] vs one [0·3%] cases; absolute risk difference 0·3%, 95% CI -0·8 to 1·5; p=0·566) and neonatal deaths did not differ significantly between groups (six [2·0%] vs three [1·0%] neonatal deaths; 1·0, -1·04 to 2·97; p=0·322). 17 serious adverse events (3%) were reported during the study: one case of intrapartum convulsion and one case of disseminated intravascular coagulation (both in the Foley group); ten perinatal deaths, including two stillbirths (both in the Foley catheter group) and eight neonatal deaths (n=5 in the misoprostol group and n=3 in the Foley catheter group); and five of neonatal morbidity, comprising birth asphyxia (n=3), septicaemia (n=1), and neonatal convulsion (n=1). INTERPRETATION: Oral misoprostol was more effective than transcervical Foley catheterisation for induction of labour in women with pre-eclampsia or hypertension. Future studies are required to assess whether oxytocin augmentation following misoprostol can be replaced by regular doses of oral misoprostol tablets. FUNDING: Medical Research Council, Department for International Development, and Wellcome Trust Joint Global Health Trials Scheme.


Assuntos
Hipertensão Induzida pela Gravidez/terapia , Trabalho de Parto Induzido/métodos , Misoprostol , Ocitócicos , Pré-Eclâmpsia/terapia , Administração Oral , Adolescente , Adulto , Análise Custo-Benefício , Feminino , Humanos , Hipertensão Induzida pela Gravidez/economia , Índia , Trabalho de Parto Induzido/economia , Pré-Eclâmpsia/economia , Gravidez , Resultado da Gravidez , Comprimidos , Cateterismo Urinário/economia , Cateterismo Urinário/estatística & dados numéricos , Vagina , Adulto Jovem
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