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OBJECTIVE: This study aimed (1) to assess the association between the length of the third stage of labor and adverse maternal outcome after vaginal birth and (2) to evaluate whether earlier manual placenta removal reduces the risk of adverse outcome. DATA SOURCES: PubMed, MEDLINE, Embase, ClinicalTrials.gov, the Cochrane Library, Journals@Ovid, and the World Health Organization International Clinical Trials Registry were searched from January 1, 2000, to June 13, 2023. STUDY ELIGIBILITY CRITERIA: All studies that assessed adverse maternal outcome, defined as any maternal complication after vaginal birth, concerning the length of the third stage of labor and the timing of manual placenta removal were included. METHODS: The included studies were evaluated using the Conducting Systematic Reviews and Meta-Analyses of Observational Studies of Etiology methodology. Pooled odds ratios with 95% confidence intervals were calculated. Heterogeneity (I2 test) was assessed, subgroup analyses were performed, and 95% prediction intervals were calculated. RESULTS: To meet the first objective, 18 cohort studies were included. The assessed cutoff values for the length of the third stage of labor were 15, 30, and 60 minutes. Women with a third stage of labor of ≥15 minutes had an increased risk of postpartum hemorrhage compared with those with a third stage of labor of <15 minutes (odds ratio, 5.55; 95% confidence interval, 1.74-17.72). For women without risk factors for postpartum hemorrhage, the odds ratio was 2.20 (95% confidence interval, 0.75-6.49). Among women with a third stage of labor of ≥60 minutes vs women with a third stage of labor of <60 minutes, the odds ratio was 3.72 (95% confidence interval, 2.36-5.89). The incidence of red blood cell transfusion was higher for a third stage of labor of ≥30 minutes than for a third stage of labor of <30 minutes (odds ratio, 3.23; 95% confidence interval, 2.26-4.61). Of note, 3 studies assessed the timing of placenta removal and the risk of adverse maternal outcome. However, the results could not be pooled because of the different outcome measures. Moreover, 1 randomized controlled trial (RCT) reported a significantly higher incidence of hemodynamic compromise in women with manual placenta removal at 15 minutes than in women with manual placenta removal at 10 minutes (30/156 [19.2%] vs 10/156 [6.4%], respectively), whereas 2 observational studies reported a lower risk of bleeding among women without manual placenta removal. CONCLUSION: Although the risk of adverse maternal outcome after vaginal birth increases when the third stage of labor exceeds 15 minutes, there is no convincing supporting evidence that reducing the length of the third stage of labor by earlier manual removal of the placenta can reduce the incidence of adverse maternal outcome.
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OBJECTIVE: To identify the incidence and characteristics of maternal suicide. DESIGN: Nationwide population-based cohort study. SETTING: The Netherlands, 2006-2020. POPULATION: Women who died during pregnancy or within 1 year postpartum, and a reference population of women aged 25-45 years. METHODS: The Cause of Death Register and Medical Birth Register were linked to identify women who died within 1 year postpartum. Data were combined with deaths reported to the Audit Committee for Maternal Mortality and Morbidity (ACMMM), which performs confidential enquiries. Maternal suicides were compared with a previous period (1996-2005). Risk factors were obtained by combining vital statistics databases. MAIN OUTCOME MEASURES: Comparison of incidence and proportion of maternal suicides among all maternal deaths over time, sociodemographic and patient-related risk factors and underreporting of postpartum suicides. RESULTS: The maternal suicide rate remained stable with 68 deaths: 2.6 per 100 000 live births in 2006-2020 versus 2.5 per 100 000 in 1996-2005. The proportion of suicides among all maternal deaths increased from 18% to 28%. Most suicides occurred throughout the first year postpartum (64/68); 34 (53%) of the women who died by suicide postpartum were primiparous. Compared with mid-level, low educational level was a risk factor (odds ratio 4.2, 95% confidence interval 2.3-7.9). Of 20 women reported to the ACMMM, 11 (55%) had a psychiatric history and 13 (65%) were in psychiatric treatment at the time of death. Underreporting to ACMMM was 78%. CONCLUSIONS: Although the overall maternal mortality ratio declined, maternal suicides did not and are now the leading cause of maternal mortality if late deaths up to 1 year postpartum are included. Data collection and analysis of suicides must improve.
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Mortalidade Materna , Suicídio , Humanos , Feminino , Adulto , Gravidez , Suicídio/estatística & dados numéricos , Países Baixos/epidemiologia , Fatores de Risco , Estudos de Coortes , Pessoa de Meia-Idade , Incidência , Período Pós-Parto , Sistema de Registros , Causas de Morte , Complicações na Gravidez/mortalidade , Complicações na Gravidez/epidemiologiaRESUMO
Most very premature infants breathe at birth but require respiratory support in order to stimulate and support their breathing. A significant proportion of premature infants are affected by chorioamnionitis, defined as an umbrella term for antenatal inflammation of the foetal membranes and umbilical vessels. Chorioamnionitis produces inflammatory mediators that potentially depress the respiratory drive generated in the brainstem. Such respiratory depression could maintain itself by delaying lung aeration, hampering respiratory support at birth and putting infants at risk of hypoxic injury. This inflammatory-mediated respiratory depression may contribute to an association between chorioamnionitis and increased requirement of neonatal resuscitation in premature infants at birth. This narrative review summarises mechanisms on how respiratory drive and spontaneous breathing could be influenced by chorioamnionitis and provides possible interventions to stimulate spontaneous breathing. Conclusion: Chorioamnionitis could possibly depress respiratory drive and spontaneous breathing in premature infants at birth. Interventions to stimulate spontaneous breathing could therefore be valuable. What is Known: ⢠A large proportion of premature infants are affected by chorioamnionitis, antenatal inflammation of the foetal membranes and umbilical vessels. What is New: ⢠Premature infants affected by chorioamnionitis might be exposed to higher concentrations of respiratory drive inhibitors which could depress breathing at birth. ⢠Premature infants affected by chorioamnionitis seem to be associated with a higher and more extensive requirement of resuscitation at birth.
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Corioamnionite , Recém-Nascido Prematuro , Humanos , Corioamnionite/fisiopatologia , Recém-Nascido , Gravidez , Feminino , Respiração , Síndrome do Desconforto Respiratório do Recém-Nascido/fisiopatologia , Síndrome do Desconforto Respiratório do Recém-Nascido/terapiaRESUMO
INTRODUCTION: Tanzania has one of the highest burdens of perinatal mortality, with a higher risk among urban versus rural women. To understand the characteristics of perinatal mortality in urban health facilities, study objectives were: I. To assess the incidence of perinatal deaths in public health facilities in Dar es Salaam and classify these into a) pre-facility stillbirths (absence of fetal heart tones on admission to the study health facilities) and b) intra-facility perinatal deaths before discharge; and II. To identify determinants of perinatal deaths by comparing each of the two groups of perinatal deaths with healthy newborns. METHODS: This was a retrospective cohort study among women who gave birth in five urban, public health facilities in Dar es Salaam. I. Incidence of perinatal death in the year 2020 was calculated based on routinely collected health facility records and the Perinatal Problem Identification Database. II. An embedded case-control study was conducted within a sub-population of singletons with birthweight ≥ 2000 g (excluding newborns with congenital malformations); pre-facility stillbirths and intra-facility perinatal deaths were compared with 'healthy newborns' (Apgar score ≥ 8 at one and ≥ 9 at five minutes and discharged home alive). Descriptive and logistic regression analyses were performed to explore the determinants of deaths. RESULTS: A total of 37,787 births were recorded in 2020. The pre-discharge perinatal death rate was 38.3 per 1,000 total births: a stillbirth rate of 27.7 per 1,000 total births and an intra-facility neonatal death rate of 10.9 per 1,000 live births. Pre-facility stillbirths accounted for 88.4% of the stillbirths. The case-control study included 2,224 women (452 pre-facility stillbirths; 287 intra-facility perinatal deaths and 1,485 controls), 99% of whom attended antenatal clinic (75% with more than three visits). Pre-facility stillbirths were associated with low birth weight (cOR 4.40; (95% CI: 3.13-6.18) and with maternal hypertension (cOR 4.72; 95% CI: 3.30-6.76). Intra-facility perinatal deaths were associated with breech presentation (aOR 40.3; 95% CI: 8.75-185.61), complications in the second stage (aOR 20.04; 95% CI: 12.02-33.41), low birth weight (aOR 5.57; 95% CI: 2.62-11.84), cervical dilation crossing the partograph's action line (aOR 4.16; 95% CI:2.29-7.56), and hypertension during intrapartum care (aOR 2.9; 95% CI 1.03-8.14), among other factors. CONCLUSION: The perinatal death rate in the five urban hospitals was linked to gaps in the quality of antenatal and intrapartum care, in the study health facilities and in lower-level referral clinics. Urgent action is required to implement context-specific interventions and conduct implementation research to strengthen the urban referral system across the entire continuum of care from pregnancy onset to postpartum. The role of hypertensive disorders in pregnancy as a crucial determinant of perinatal deaths emphasizes the complexities of maternal-perinatal health within urban settings.
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Hipertensão , Morte Perinatal , Gravidez , Recém-Nascido , Feminino , Humanos , Natimorto/epidemiologia , Mortalidade Perinatal , Estudos de Coortes , Estudos de Casos e Controles , Estudos Retrospectivos , Tanzânia/epidemiologia , Incidência , Hospitais UrbanosRESUMO
BACKGROUND: Ethiopia made a national licensing examination (NLE) for associate clinician anesthetists a requirement for entry into the practice workforce. However, there is limited empirical evidence on whether the NLE scores of associate clinicians predict the quality of health care they provide in low-income countries. This study aimed to assess the association between anesthetists' NLE scores and three selected quality of patient care indicators. METHODS: A multicenter longitudinal observational study was conducted between January 8 and February 7, 2023, to collect quality of care (QoC) data on surgical patients attended by anesthetists (n = 56) who had taken the Ethiopian anesthetist NLE since 2019. The three QoC indicators were standards for safe anesthesia practice, critical incidents, and patient satisfaction. The medical records of 991 patients were reviewed to determine the standards for safe anesthesia practice and critical incidents. A total of 400 patients responded to the patient satisfaction survey. Multivariable regressions were employed to determine whether the anesthetist NLE score predicted QoC indicators. RESULTS: The mean percentage of safe anesthesia practice standards met was 69.14%, and the mean satisfaction score was 85.22%. There were 1,120 critical incidents among 911 patients, with three out of five experiencing at least one. After controlling for patient, anesthetist, facility, and clinical care-related confounding variables, the NLE score predicted the occurrence of critical incidents. For every 1% point increase in the total NLE score, the odds of developing one or more critical incidents decreased by 18% (aOR = 0.82; 95% CI = 0.70 = 0.96; p = 0.016). No statistically significant associations existed between the other two QoC indicators and NLE scores. CONCLUSION: The NLE score had an inverse relationship with the occurrence of critical incidents, supporting the validity of the examination in assessing graduates' ability to provide safe and effective care. The lack of an association with the other two QoC indicators requires further investigation. Our findings may help improve education quality and the impact of NLEs in Ethiopia and beyond.
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Anestesistas , Satisfação do Paciente , Qualidade da Assistência à Saúde , Humanos , Etiópia , Estudos Longitudinais , Masculino , Feminino , Adulto , Qualidade da Assistência à Saúde/normas , Anestesistas/normas , Pessoa de Meia-Idade , Anestesiologia/normas , Competência Clínica/normas , Avaliação Educacional/métodos , Avaliação Educacional/normasRESUMO
OBJECTIVES: Sepsis is a common cause of maternal mortality and morbidity. Early detection and rapid management are essential. In this study, we evaluate the compliance with the implemented maternity-specific Early Warning Score (EWS), Rapid Response Team (RRT) protocol and the Surviving Sepsis Campaign (SSC) Hour-1 Bundle in a tertiary hospital in the Netherlands. METHODS: We performed a retrospective patient chart review from July 2019 to June 2020 at the Leiden University Medical Centre. We included women who received therapeutic antibiotics and were admitted for at least 24 hours. RESULTS: We included 240 women: ten were admitted twice and one woman three times, comprising 252 admissions. A clinical diagnosis of sepsis was made in 22 women. The EWS was used in 29% (n = 73/252) of admissions. Recommendations on the follow-up of the EWS were carried out in 53% (n = 46/87). Compliance with the RRT protocol was highest for assessment by a medical doctor within 30 minutes (n = 98/117, 84%) and lowest for RRT involvement (n = 7/23, 30%). In women with sepsis, compliance with the SSC Bundle was highest for acquiring blood cultures (n = 19/22, 85%), while only 64% (n = 14/22) received antibiotics within 60 minutes of the sepsis diagnosis. CONCLUSION: The adherence to the maternity-specific EWS and the SSC Hour-1 bundle was insufficient, even within this tertiary setting in a high-income country.
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Fidelidade a Diretrizes , Sepse , Centros de Atenção Terciária , Humanos , Feminino , Países Baixos , Centros de Atenção Terciária/organização & administração , Estudos Retrospectivos , Sepse/terapia , Sepse/diagnóstico , Fidelidade a Diretrizes/estatística & dados numéricos , Adulto , Gravidez , Antibacterianos/uso terapêutico , Escore de Alerta Precoce , Guias de Prática Clínica como Assunto , Complicações Infecciosas na Gravidez/tratamento farmacológico , Complicações Infecciosas na Gravidez/terapia , Complicações Infecciosas na Gravidez/diagnósticoRESUMO
BACKGROUND: Planned caesarean section (CS) is a risk factor for neonatal respiratory distress caused by a greater volume of airway liquid in the absence of uterine contractions.Performing a newly conceptualised knee-to-chest flexion (KCF) manoeuvre at birth, mimicking uterine contraction-induced flexion may aid in expelling excess lung liquid. OBJECTIVES: To test whether performing a KCF manoeuvre at birth is feasible in infants born after planned CS and to test whether KCF leads to visible expulsion of lung liquid. METHODS: Single-centre prospective interventional study in term infants born by planned CS at Leiden University Medical Centre, Netherlands. KCF was performed for a maximum of 45 s. Baseline characteristics were collected, primary outcome was ability to perform KCF and secondary outcome was any visible expulsion of fluid. RESULTS: In 39 infants (mean (SD) gestational age 38.0 (0.7) weeks, birth weight 3537 (440) g), KCF could be performed in 21/39 (54%), whereas 18/39 (46.2%) starting vigorous breathing before KCF could be performed. Notably, visible lung liquid expulsion occurred in 9/21 (43%) infants. KCF duration averaged 29 (18) s. In 13/21 (62 %), KCF was not performed as per standard operating procedure. No adverse events were reported. CONCLUSION: It is feasible to perform KCF at birth in a large proportion of term infants born by planned CS, with visible expulsion of liquid in a significant proportion of these infants. Training healthcare providers to perform a standardised KCF could increase feasibility and success. Further studies are needed to assess feasibility and effectiveness of KCF. TRIAL REGISTRATION NUMBER: NL74285.058.20.
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Objective: Prolonged labor is the commonest indication for intrapartum cesarean section, but definitions are inconsistent and some common definitions were recently found to overestimate the speed of physiological labor. The objective of this review is to establish an overview of synonyms and definitions used in the literature for prolonged labor, separated into first and second stages, and establish types of definitions used. Data sources: A systematic search was conducted in PubMed, Embase, Web of Science, Cochrane Library, Emcare, and Academic Search Premier. Study eligibility criteria: All articles in English that (1) attempted to define prolonged labor, (2) included a definition of prolonged labor, or (3) included any synonym for prolonged labor, were included. Methods: Data on study design, year of publication, country or region of origin, synonyms used, definition of prolonged first and/or second stage, and origin of provided definition (if not primarily established by the study) were collected into a database. Results: In total, 3402 abstracts and 536 full-text papers were screened, and 232 papers were included. Our search established 53 synonyms for prolonged labor. Forty-three studies defined prolonged labor and 189 studies adopted a definition of prolonged labor. Definitions for prolonged first stage of labor were categorized into: time-based (n=14), progress-based (n=12), clinician-based (n=5), or outcome-based (n=4). For the 33 studies defining prolonged second stage, the majority of definitions (n=25) were time-based, either based on total duration or duration of no descent of the presenting part. Conclusions: Despite efforts to arrive at uniform labor curves, there is still little uniformity in definitions of prolonged labor. Consensus on which definition to use is called for, in order to safely and respectfully allow physiological labor progress, ensure timely management, and assess and compare incidence of prolonged labor between settings.
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Objective: To investigate trends and rates of severe perineal trauma (SPT), also known as obstetric anal sphincter injury (OASI), between midwife-led and obstetrician-led care in the Netherlands, and factors associated with SPT. Methods: This nationwide cohort study included registry data from 2000 to 2019 (n = 2,169,950) of spontaneous vaginal births of term, live, cephalic, single infants, without a (previous) caesarean section or assisted vaginal birth.First, trends of SPT and episiotomy were shown. Second, differences in SPT rates between midwife- and obstetrician-led care were assessed. Third, associations of care factors with SPT were examined. Multivariable logistic regression analyses were used to determine which factors were important in the associations. All outcomes were stratified for parity. Results: Over time, the SPT incidence increased mainly in midwife-led care and episiotomy rates decreased. Compared to midwife-led care, SPT rates were lower in obstetrician-led care among primiparous women (aOR 0.78; 99 % CI 0.74-0.81) and comparable among multiparous women (aOR 1.04; 99 % CI 0.99-1.10). Among women without epidural analgesia, these differences were smaller for primiparous women (aOR 0.88; 99 % CI 0.84-0.92), but the SPT rate was higher in obstetrician-led care among multiparous women (aOR 1.09; 99 % CI 1.03-1.15). Among women without shoulder dystocia, induction, augmentation, and pain medication, SPT rates were comparable among primiparous women, but higher among multiparous women in obstetrician-led care. In midwife-led care, SPT occurred more often among hospital versus home births. In obstetrician-led care, lower SPT incidences were found among births with epidural analgesia and for multiparous women with induction or augmentation. Conclusions: Among spontaneous vaginal births, induction, augmentation, and epidural analgesia in obstetrician-led care may be an explanatory factor for the higher incidence of SPT among primiparous women in midwife-led care. More research is needed to explain differences in SPT rates and to understand how SPT can be prevented, while maintaining a high intact perineum rate.
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INTRODUCTION: Rising facility births in sub-Saharan Africa (SSA) mask inequalities in higher-level emergency care-typically in hospitals. Limited research has addressed hospital use in women at risk of or with complications, such as high parity, linked to poverty and rurality, for whom hospital care is essential. We aimed to address this gap, by comparatively assessing hospital use in rural SSA by wealth and parity. METHODS: Countries in SSA with a Demographic and Health Survey since 2015 were included. We assessed rural hospital childbirth stratifying by wealth (wealthier/poorer) and parity (nulliparity/high parity≥5), and their combination. We computed percentages, 95% CIs and percentage-point differences, by stratifier level. To compare hospital use across countries, we produced a composite index, including six utilisation and equality indicators. RESULTS: This cross-sectional study included 18 countries. In all, a minority of rural women used hospitals for childbirth (2%-29%). There were disparities by wealth and parity, and poorer, high-parity women used hospitals least. The poorer/wealthier difference in utilisation among high-parity women ranged between 1.3% (Mali) and 13.2% (Rwanda). We found use and equality of hospitals in rural settings were greater in Malawi and Liberia, followed by Zimbabwe, the Gambia and Rwanda. DISCUSSION: Inequalities identified across 18 countries in rural SSA indicate poor, higher-risk women of high parity had lower use of hospitals for childbirth. Specific policy attention is urgently needed for this group where disadvantage accumulates.
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Parto Obstétrico , Parto , Feminino , Humanos , Gravidez , Estudos Transversais , Hospitais , DemografiaRESUMO
Introduction: In 2016, UNAIDS set ambitious targets to reduce global HIV infections by 75% by 2020 and 90% by 2030, based on the 2.1 million new infections reported in 2010. However, by 2022, new HIV infections had only decreased by 38%, from 2.1 million in 2010 to 1.3 million in 2022, raising concerns about reaching the 2030 goal. Female sex workers (FSWs) in sub-Saharan Africa face a disproportionately high risk of HIV acquisition, contributing 5%-20% of all new infections in several countries in the region. This analysis investigates HIV seroconversion and associated factors among FSWs, offering insights into critical interventions for preventing HIV transmission in this population and advancing the goal of ending the HIV pandemic by 2030. Methods: We conducted a retrospective cohort study involving 17,977 FSWs who initially tested HIV negative upon enrollment in the Sauti project between October 2016 and September 2018. HIV incidence rates were calculated by dividing the number of new HIV cases by observed person-time within the cohort. Cox regression analysis identified factors associated with seroconversion. Results: The study revealed an HIV incidence rate of 8.6 per 100 person-years among FSWs [95% confidence interval (CI): 8.1-9.1]. Factors independently associated with HIV seroconversion included age 35 years or older [adjusted hazard ratio (aHR): 2.53; 95% CI: 2.03-3.14], unprotected sex (aHR: 1.27; 95% CI: 1.13-1.42), STI symptoms (aHR: 1.99; 95% CI: 1.67-2.38), and alcohol consumption before sex (aHR: 1.20; 95% CI: 1.07-1.34). Conclusion: Targeted interventions are vital in curbing HIV transmission among FSWs, with a focus on expanding access to primary HIV prevention services, particularly for older FSWs who face heightened risk. Tailored sexual health education programs are imperative to encourage consistent condom use and enable informed decision-making. Accessible and timely STI screening and treatment services are crucial to mitigate HIV transmission risk. Collaborative partnerships between healthcare providers, community organizations, and government agencies are essential in implementing these interventions among FSWs.
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Background: The use of mobile health technology (mHealth) by community health workers (CHWs) can strengthen community-based service delivery and improve access to and quality of healthcare. Objective: This qualitative study sought to explore experiences and identify factors influencing the use of an integrated smartphone-based mHealth called YendaNafe by CHWs in rural Malawi. Methods: Using pre-tested interview guides, between August and October 2022, we conducted eight focus group discussions with CHWs (n = 69), four in-depth interviews with CHW supervisors, and eight key informant interviews in Neno District, Malawi. We audio-recorded and transcribed the interviews verbatim and organized them for analysis in Dedoose V9.0.62. We used an inductive analysis technique to analyze the data. We further applied the six domains of the socio-technical system (STS) framework to map factors influencing the use of YendaNafe. Results: User experiences and facilitators and barriers were the two main themes that emerged. mHealth was reported to improve the task efficiency, competence, trust, and perceived professionalism of CHWs. CHWs less frequently referred to cultural factors influencing app uptake. However, for other social systems, they identified relationships and trust with stakeholders, availability of training and programmatic support, and performance monitoring and feedback as influencing the use of YendaNafe. From the STS technical domain, the availability and adequacy of hardware such as phones, mobile connectivity, and usability influenced the use of YendaNafe. Conclusions: Despite the initial discomfort, CHWs found mHealth helpful in supporting their service delivery tasks. Identifying and addressing social and technical factors during mHealth implementation may help improve end users' attitudes and uptake.
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OBJECTIVE: To quantify the association between prophylactic radiologic interventions and perioperative blood loss during cesarean delivery in women with placenta accreta spectrum disorder through a systematic review and network meta-analysis. DATA SOURCES: On January 3, 2023, a literature search was conducted in PubMed, EMBASE, Cochrane Library, and Web of Science. We also checked ClinicalTrials.gov retrospectively. Prophylactic radiologic interventions to reduce bleeding during cesarean delivery involved preoperative placement of balloon catheters, distal (internal or common iliac arteries) or proximal (abdominal aorta), or sheaths (uterine arteries). The primary outcome was volume of blood loss; secondary outcomes were the number of red blood cell units transfused and adverse events. Studies including women who received an emergency cesarean delivery were excluded. METHODS OF STUDY SELECTION: Two authors independently screened citations for relevance, extracted data, and assessed the risk of bias of individual studies with the Cochrane Risk of Bias in Non-randomized Studies of Interventions tool. TABULTATION, INTEGRATION, AND RESULTS: From a total of 1,332 screened studies, 50 were included in the final analysis, comprising 5,962 women. These studies consisted of two randomized controlled trials and 48 observational studies. Thirty studies compared distal balloon occlusion with a control group, with a mean difference in blood loss of -406 mL (95% CI, -645 to -167). Fourteen studies compared proximal balloon occlusion with a control group, with a mean difference of -1,041 mL (95% CI, -1,371 to -710). Sensitivity analysis excluding studies with serious or critical risk of bias provided similar results. Five studies compared uterine artery embolization with a control group, all with serious or critical risk of bias; the mean difference was -936 mL (95% CI, -1,522 to -350). Reported information on adverse events was limited. CONCLUSION: Although the predominance of observational studies in the included literature warrants caution in interpreting the findings of this meta-analysis, our findings suggest that prophylactic placement of balloon catheters or sheaths before planned cesarean delivery in women with placenta accreta spectrum disorder may, in some cases, substantially reduce perioperative blood loss. Further study is required to quantify the efficacy according to various severities of placenta accreta spectrum disorder and the associated safety of these radiologic interventions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022320922.
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Oclusão com Balão , Cesárea , Placenta Acreta , Hemorragia Pós-Parto , Humanos , Feminino , Hemorragia Pós-Parto/prevenção & controle , Hemorragia Pós-Parto/etiologia , Gravidez , Cesárea/efeitos adversos , Oclusão com Balão/métodos , Perda Sanguínea Cirúrgica/prevenção & controle , Embolização da Artéria Uterina/métodos , Metanálise em RedeRESUMO
BACKGROUND: Mortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor for these complications is hemodynamic instability. Pre-clinical studies suggest that the timing of umbilical cord clamping affects hemodynamic stability during transition. Standard care is time-based cord clamping (TBCC), with clamping irrespective of lung aeration. It is unknown whether delaying cord clamping until lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) is more beneficial. This document describes the statistical analyses for the ABC3 trial, which aims to assess the efficacy and safety of PBCC, compared to TBCC. METHODS: The ABC3 trial is a multicenter, randomized trial investigating PBCC (intervention) versus TBCC (control) in very preterm infants. The trial is ethically approved. Preterm infants born before 30 weeks of gestation are randomized after parental informed consent. The primary outcome is intact survival, defined as the composite of survival without major cerebral injury and/or NEC. Secondary short-term outcomes are co-morbidities and adverse events assessed during NICU admission, parental reported outcomes, and long-term neurodevelopmental outcomes assessed at a corrected age of 2 years. To test the hypothesis that PBCC increases intact survival, a logistic regression model will be estimated using generalized estimating equations (accounting for correlation between siblings and observations in the same center) with treatment and gestational age as predictors. This plan is written and submitted without knowledge of the data. DISCUSSION: The findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth. TRIAL REGISTRATION: ClinicalTrials.gov NCT03808051. Registered on 17 January 2019.
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Recém-Nascido Prematuro , Nascimento Prematuro , Lactente , Feminino , Recém-Nascido , Humanos , Pré-Escolar , Constrição , Recém-Nascido de muito Baixo Peso , RespiraçãoRESUMO
Background: Despite a range of available treatments, it is still sometimes challenging to treat patients with severe post-partum hemorrhage (sPPH). Objective: This study evaluated the efficacy and safety of recombinant activated factor VIIa (rFVIIa) in sPPH management. Methods: An open-label, multi-center, randomized controlled trial (RCT; NCT00370877) and four observational studies (OS; OS-1 (NCT04723979), OS-2, OS-3, and OS-4) were analyzed regarding efficacy (need for subsequent invasive procedures, including uterine compression sutures, uterine or iliac artery ligations, arterial embolization, or hysterectomy) and safety (incidence of thromboembolic events (TE) and maternal mortality) of rFVIIa for sPPH. The RCT, and OS-1 and OS-2, included a control group of women who did not receive rFVIIa (with propensity score-matching used in OS-1 and OS-2), whereas OS-3 and OS-4 provided descriptive data for rFVIIa-exposed women only. Results: A total of 446 women exposed to rFVIIa and 1717 non-exposed controls were included. In the RCT, fewer rFVIIa-exposed women (50% [21/42]) had an invasive procedure versus non-exposed women (91% [38/42]; odds ratio: 0.11; 95% confidence interval: 0.03-0.35). In OS-1, more rFVIIa-exposed women (58% [22/38]) had an invasive procedure versus non-exposed women (35% [13.3/38]; odds ratio: 2.46; 95% confidence interval: 1.06-5.99). In OS-2, 17% (3/18) of rFVIIa-exposed women and 32% (5.6/17.8) of non-exposed women had an invasive procedure (odds ratio: 0.33; 95% confidence interval: 0.03-1.75). Across all included women, TEs occurred in 1.5% (0.2% arterial and 1.2% venous) of rFVIIa-exposed women and 1.6% (0.2% arterial and 1.4% venous) of non-exposed women with available data. Conclusions: The positive treatment effect of rFVIIa on the RCT was not confirmed in the OS. However, the safety analysis did not show any increased incidence of TEs with rFVIIa treatment.