Strategies for optimising early detection and obstetric first response management of postpartum haemorrhage at caesarean birth: a modified Delphi-based international expert consensus.

OBJECTIVE: There are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international expert's consensus on evidence-based approaches for early detection and obstetric first response management of PPH intraoperatively and postoperatively in caesarean birth. DESIGN: Systematic review and three-stage modified Delphi expert consensus. SETTING: International. POPULATION: Panel of 22 global experts in PPH with diverse backgrounds, and gender, professional and geographic balance. OUTCOME MEASURES: Agreement or disagreement on strategies for early detection and first response management of PPH at caesarean birth. RESULTS: Experts agreed that the same PPH definition should apply to both vaginal and caesarean birth. For the intraoperative phase, the experts agreed that early detection should be accomplished via quantitative blood loss measurement, complemented by monitoring the woman's haemodynamic status; and that first response should be triggered once the woman loses at least 500 mL of blood with continued bleeding or when she exhibits clinical signs of haemodynamic instability, whichever occurs first. For the first response, experts agreed on immediate administration of uterotonics and tranexamic acid, examination to determine aetiology and rapid initiation of cause-specific responses. In the postoperative phase, the experts agreed that caesarean birth-related PPH should be detected primarily via frequently monitoring the woman's haemodynamic status and clinical signs and symptoms of internal bleeding, supplemented by cumulative blood loss assessment performed quantitatively or by visual estimation. Postoperative first response was determined to require an individualised approach. CONCLUSION: These agreed on proposed approaches could help improve the detection of PPH in the intraoperative and postoperative phases of caesarean birth and the first response management of intraoperative PPH. Determining how best to implement these strategies is a critical next step.

Unveiling the strong positive relationship: Maternal characteristics and neonatal outcomes in the Better Outcomes in Labour Difficulty (BOLD) study - a secondary analysis validating neonatal near miss classification.

Background: The near miss concept, denoting near collisions between aircraft, originated in aeronautics, but has recently been transferred to the neonatal context as a way of evaluating the quality of health services for newborns, especially in settings with reduced child mortality. However, there is yet no consensus regarding the underlying criteria. The most common indicators used to assess health care quality include mortality (maternal and neonatal) and life-threatening conditions. Using the World Health Organization (WHO) Better Outcomes in Labour Difficulty (BOLD) prospective cohort study data set, we conducted a secondary analysis to validate the near miss concept and explore the association between maternal and neonatal outcomes. Methods: We studied 10 203 singleton mothers treated between December 2014 and November 2015 in nine Nigerian and four Ugandan hospitals. We validated the near miss concept by testing the diagnostic accuracy (sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and odds ratio (OR)) using death as the reference variable and calculating the maternal and neonatal case fatality rates. We performed ordinal and binomial logistic regression, with the independent variables being those that had P < 0.1 in the univariate analyses. We considered the significance level of 5%. Results: We validated the neonatal near miss concept using the BOLD study data. We observed maternal and neonatal case fatality rates of 70.2% and 6.5%, with an increasing severity relationship between maternal and neonatal outcomes (P < 0.05). Ordinal logistic regression showed that gestational age <37 or >41 weeks and <8 antenatal consultations were related to a higher risk of neonatal severe outcomes, while maternal age between 30 and 34 years functioned as a protective factor against severe neonatal outcomes (SNO). Binomial logistic regression showed gestational age <37(OR = 1.46; 95% confidence interval (CI) = 1.07-1.94) or >41 weeks (OR = 2.26; 95% CI = 1.55-3.20), low educational level (OR = 1.76; 95% CI = 1.12-2.69), overweight/obesity (OR = 1.23; 95% CI = 1.02-1.47), one previous cesarean section (OR = 1.90; 95% CI = 1.36-2.61), one previous abortion (OR = 1.25; 95% CI = 1.00-1.56), and previous chronic condition (OR = 1.83; 95% CI = 1.37-2.41) were risk factors for SNO. Conclusions: The neonatal near miss concept could be used as a parameter for analysis in different health systems, to ensure that measuring of neonatal severity is comparable across health care units. In this analysis, we observed a progressive association between maternal severity and the severity of the newborns' outcomes.

Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia.

BACKGROUND: Magnesium sulphate is the drug of choice for the prevention and treatment of women with eclampsia. Regimens for administration of this drug have evolved over the years, but there is no clarity on the comparative benefits or harm of alternative regimens. This is an update of a review first published in 2010. OBJECTIVES: To assess if one magnesium sulphate regimen is better than another when used for the care of women with pre-eclampsia or eclampsia, or both, to reduce the risk of severe morbidity and mortality for the woman and her baby. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (29 April 2022), and reference lists of retrieved studies. SELECTION CRITERIA: We included randomised trials and cluster-randomised trials comparing different regimens for administration of magnesium sulphate used in women with pre-eclampsia or eclampsia, or both. Comparisons included different dose regimens, intramuscular versus intravenous route for maintenance therapy, and different durations of therapy. We excluded studies with quasi-random or cross-over designs. We included abstracts of conference proceedings if compliant with the trustworthiness assessment. DATA COLLECTION AND ANALYSIS: For this update, two review authors assessed trials for inclusion, performed risk of bias assessment, and extracted data. We checked data for accuracy. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: For this update, a total of 16 trials (3020 women) met our inclusion criteria: four trials (409 women) compared regimens for women with eclampsia, and 12 trials (2611 women) compared regimens for women with pre-eclampsia. Most of the included trials had small sample sizes and were conducted in low- and middle-income countries. Eleven trials reported adequate randomisation and allocation concealment. Blinding of participants and clinicians was not possible in most trials. The included studies were for the most part at low risk of attrition and reporting bias. Treatment of women with eclampsia (four comparisons) One trial compared a loading dose-alone regimen with a loading dose plus maintenance dose regimen (80 women). It is uncertain whether either regimen has an effect on the risk of recurrence of convulsions or maternal death (very low-certainty evidence). One trial compared a lower-dose regimen with standard-dose regimen over 24 hours (72 women). It is uncertain whether either regimen has an effect on the risk of recurrence of convulsion, severe morbidity, perinatal death, or maternal death (very low-certainty evidence). One trial (137 women) compared intravenous (IV) versus standard intramuscular (IM) maintenance regimen. It is uncertain whether either route has an effect on recurrence of convulsions, death of the baby before discharge (stillbirth and neonatal death), or maternal death (very low-certainty evidence). One trial (120 women) compared a short maintenance regimen with a standard (24 hours after birth) maintenance regimen. It is uncertain whether the duration of the maintenance regimen has an effect on recurrence of convulsions, severe morbidity, or side effects such as nausea and respiratory failure. A short maintenance regimen may reduce the risk of flushing when compared to a standard 24 hours maintenance regimen (risk ratio (RR) 0.27, 95% confidence interval (CI) 0.08 to 0.93; 1 trial, 120 women; low-certainty evidence). Many of our prespecified critical outcomes were not reported in the included trials. Prevention of eclampsia for women with pre-eclampsia (five comparisons) Two trials (462 women) compared loading dose alone with loading dose plus maintenance therapy. Low-certainty evidence suggests an uncertain effect with either regimen on the risk of eclampsia (RR 2.00, 95% CI 0.61 to 6.54; 2 trials, 462 women) or perinatal death (RR 0.50, 95% CI 0.19 to 1.36; 2 trials, 462 women). One small trial (17 women) compared an IV versus IM maintenance regimen for 24 hours. It is uncertain whether IV or IM maintenance regimen has an effect on eclampsia or stillbirth (very low-certainty evidence). Four trials (1713 women) compared short postpartum maintenance regimens with continuing for 24 hours after birth. Low-certainty evidence suggests there may be a wide range of benefit or harm between groups regarding eclampsia (RR 1.99, 95% CI 0.18 to 21.87; 4 trials, 1713 women). Low-certainty evidence suggests there may be little or no effect on severe morbidity (RR 0.96, 95% CI 0.71 to 1.29; 2 trials, 1233 women) or side effects such as respiratory depression (RR 0.80, 95% CI 0.25 to 2.61; 2 trials, 1424 women). Three trials (185 women) compared a higher-dose maintenance regimen versus a lower-dose maintenance regimen. It is uncertain whether either regimen has an effect on eclampsia (very low-certainty evidence). Low-certainty evidence suggests that a higher-dose maintenance regimen has little or no effect on side effects when compared to a lower-dose regimen (RR 0.79, 95% CI 0.61 to 1.01; 1 trial 62 women). One trial (200 women) compared a maintenance regimen by continuous infusion versus a serial IV bolus regimen. It is uncertain whether the duration of the maintenance regimen has an effect on eclampsia, side effects, perinatal death, maternal death, or other neonatal morbidity (very low-certainty evidence). Many of our prespecified critical outcomes were not reported in the included trials. AUTHORS' CONCLUSIONS: Despite the number of trials evaluating various magnesium sulphate regimens for eclampsia prophylaxis and treatment, there is still no compelling evidence that one particular regimen is more effective than another. Well-designed randomised controlled trials are needed to answer this question.

The development of the WHO Labour Care Guide: an international survey of maternity care providers.

BACKGROUND: The partograph is the most commonly used labour monitoring tool in the world. However, it has been used incorrectly or inconsistently in many settings. In 2018, a WHO expert group reviewed and revised the design of the partograph in light of emerging evidence, and they developed the first version of the Labour Care Guide (LCG). The objective of this study was to explore opinions of skilled health personnel on the first version of the WHO Labour Care Guide. METHODS: Skilled health personnel (including obstetricians, midwives and general practitioners) of any gender from Africa, Asia, Europe and Latin America were identified through a large global research network. Country coordinators from the network invited 5 to 10 mid-level and senior skilled health personnel who had worked in labour wards anytime in the last 5 years. A self-administered, anonymous, structured, online questionnaire including closed and open-ended questions was designed to assess the clarity, relevance, appropriateness of the frequency of recording, and the completeness of the sections and variables on the LCG. RESULTS: A total of 110 participants from 23 countries completed the survey between December 2018 and January 2019. Variables included in the LCG were generally considered clear, relevant and to have been recorded at the appropriate frequency. Most sections of the LCG were considered complete. Participants agreed or strongly agreed with the overall design, structure of the LCG, and the usefulness of reference thresholds to trigger further assessment and actions. They also agreed that LCG could potentially have a positive impact on clinical decision-making and respectful maternity care. Participants disagreed with the value of some variables, including coping, urine, and neonatal status. CONCLUSIONS: Future end-users of WHO Labour Care Guide considered the variables to be clear, relevant and appropriate, and, with minor improvements, to have the potential to positively impact clinical decision-making and respectful maternity care.

Maternal BMI at the time of birth and selected risk factors associated with severe neonatal outcomes: a secondary analysis of the WHO Better Outcomes in Labour Difficulty (BOLD) project.

The main objective of this secondary analysis was to describe the nutritional status of the Better Outcomes in Labour Difficulty (BOLD) project study population and determine possible associations between maternal nutritional status (as reflected by maternal BMI at the time of birth) and severe neonatal outcomes (SNO). We also analysed previous and index maternal pathologies to determine associations with neonatal outcomes. We used the classification designed by Atalah for maternal BMI and compared with the Hyperglycaemia and Adverse Pregnancy Outcome study one. To describe the nutritional status of this population, figures of distribution and test of normality related to weight and BMI were presented for the women and their babies. To explore the association between maternal BMI data and SNO, the χ2 test was performed. To identify a maternal characteristic or a group of characteristics that could predict SNO, we used Fisher's exact test using previous maternal pathology collected in the BOLD project as well as that in the index pregnancy. In this study, BMI at the time of birth was not associated with neonatal near miss or death. We found that previous maternal obesity, diabetes and chronic hypertension were associated with SNO. Maternal pathology in the index pregnancy such as other obstetric haemorrhage, pre-eclampsia, anaemia and gestational diabetes was associated with SNO.

Development of caesarean section prediction models: secondary analysis of a prospective cohort study in two sub-Saharan African countries.

BACKGROUND: Caesarean section is recommended in situations in which vaginal birth presents a greater likelihood of adverse maternal or perinatal outcomes than normal. However, it is associated with a higher risk of complications, especially when performed without a clear medical indication. Since labour attendants have no standardised clinical method to assist in this decision, statistical tools developed based on multiple labour variables may be an alternative. The objective of this paper was to develop and evaluate the accuracy of models for caesarean section prediction using maternal and foetal characteristics collected at admission and through labour. METHOD: This is a secondary analysis of the World Health Organization's Better Outcomes in Labour Difficulty prospective cohort study in two sub-Saharan African countries. Data were collected from women admitted for labour and childbirth in 13 hospitals in Nigeria as well as Uganda between 2014 and 2015. We applied logistic regression to develop different models to predict caesarean section, based on the time when intrapartum assessment was made. To evaluate discriminatory capacity of the various models, we calculated: area under the curve, diagnostic accuracy, positive predictive value, negative predictive value, sensitivity and specificity. RESULTS: A total of 8957 pregnant women with 12.67% of caesarean births were used for model development. The model based on labour admission characteristics showed an area under the curve of 78.70%, sensitivity of 63.20%, specificity of 78.68% and accuracy of 76.62%. On the other hand, the models that applied intrapartum assessments performed better, with an area under the curve of 93.66%, sensitivity of 80.12%, specificity of 89.26% and accuracy of 88.03%. CONCLUSION: It is possible to predict the likelihood of intrapartum caesarean section with high accuracy based on labour characteristics and events. However, the accuracy of this prediction is considerably higher when based on information obtained throughout the course of labour.

The development of a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool for Better Outcomes in Labour Difficulty (BOLD): study protocol.

BACKGROUND: The partograph is currently the main tool available to support decision-making of health professionals during labour. However, the rate of appropriate use of the partograph is disappointingly low. Apart from limitations that are associated with partograph use, evidence of positive impact on labour-related health outcomes is lacking. The main goal of this study is to develop a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool. The primary objectives are: to identify the essential elements of intrapartum monitoring that trigger the decision to use interventions aimed at preventing poor labour outcomes; to develop a simplified, monitoring-to-action algorithm for labour management; and to compare the diagnostic performance of SELMA and partograph algorithms as tools to identify women who are likely to develop poor labour-related outcomes. METHODS/DESIGN: A prospective cohort study will be conducted in eight health facilities in Nigeria and Uganda (four facilities from each country). All women admitted for vaginal birth will comprise the study population (estimated sample size: 7,812 women). Data will be collected on maternal characteristics on admission, labour events and pregnancy outcomes by trained research assistants at the participating health facilities. Prediction models will be developed to identify women at risk of intrapartum-related perinatal death or morbidity (primary outcomes) throughout the course of labour. These predictions models will be used to assemble a decision-support tool that will be able to suggest the best course of action to avert adverse outcomes during the course of labour. To develop this set of prediction models, we will use up-to-date techniques of prognostic research, including identification of important predictors, assigning of relative weights to each predictor, estimation of the predictive performance of the model through calibration and discrimination, and determination of its potential for application using internal validation techniques. DISCUSSION: This research offers an opportunity to revisit the theoretical basis of the partograph. It is envisioned that the final product would help providers overcome the challenging tasks of promptly interpreting complex labour information and deriving appropriate clinical actions, and thus increase efficiency of the care process, enhance providers' competence and ultimately improve labour outcomes. Please see related articles ' http://dx.doi.org/10.1186/s12978-015-0027-6 ' and ' http://dx.doi.org/10.1186/s12978-015-0028-5 '.