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.

Women's caesarean section preferences: A multicountry cross-sectional survey in low- and middle-income countries.

OBJECTIVE: To measure the proportion of women's preferences for CS in hospitals with high caesarean section rates and to identify related factors. DESIGN: A cross-sectional hospital-based postpartum survey was conducted. We used multilevel multivariate logistic regression and probit models to analyse the association between women's caesarean section preferences and maternal characteristics. Probit models take into account selection bias while excluding women who had no preference. SETTING: Thirty-two hospitals in Argentina, Thailand, Vietnam and Burkina Faso were selected. PARTICIPANTS: A total of 1,979 post-partum women with no potential medical need for caesarean section were included among a representative sample of women who delivered at each of the participating facilities during the data collection period. FINDINGS: The overall caesarean section rate was 23.3 %. Among women who declared a preference in late pregnancy, 9 % preferred caesarean section, ranging from 1.8 % in Burkina Faso to 17.8 % in Thailand. Primiparous women were more likely to prefer a caesarean section than multiparous women (ß=+0.16 [+0.01; +0.31]; p = 0.04). Among women who preferred caesarean section, doctors were frequently cited as the main influencers, and "avoid pain in labour" was the most common perceived benefit of caesarean section. KEY CONCLUSIONS: Our results suggest that a high proportion of women prefer vaginal birth and highlight that the preference for caesarean section is linked to women's fear of pain and the influence of doctors. These results can inform the development of interventions aimed at supporting women and their preferences, providing them with evidence-based information and changing doctors' behaviour in order to reduce the number of unnecessary caesarean sections. CLINICAL TRIAL REGISTRY: The QUALI-DEC trial is registered on the Current Controlled Trials website (https://www.isrctn.com/) under the number ISRCTN67214403.

How does hospital organisation influence the use of caesarean sections in low- and middle-income countries? A cross-sectional survey in Argentina, Burkina Faso, Thailand and Vietnam for the QUALI-DEC project.

BACKGROUND: Improving the understanding of non-clinical factors that lead to the increasing caesarean section (CS) rates in many low- and middle-income countries is currently necessary to meet the challenge of implementing effective interventions in hospitals to reverse the trend. The objective of this study was to study the influence of organizational factors on the CS use in Argentina, Vietnam, Thailand and Burkina Faso. METHODS: A cross-sectional hospital-based postpartum survey was conducted in 32 hospitals (8 per country). We selected women with no potential medical need for CS among a random sample of women who delivered at each of the participating facilities during the data collection period. We used multilevel multivariable logistic regression to analyse the association between CS use and organizational factors, adjusted on women's characteristics. RESULTS: A total of 2,092 low-risk women who had given birth in the participating hospitals were included. The overall CS rate was 24.1%, including 4.9% of pre-labour CS and 19.3% of intra-partum CS. Pre-labour CS was significantly associated with a 24-hour anaesthetist dedicated to the delivery ward (ORa = 3.70 [1.41; 9.72]) and with the possibility to have an individual room during labour and delivery (ORa = 0.28 [0.09; 0.87]). Intra-partum CS was significantly associated with a higher bed occupancy level (ORa = 1.45 [1.09; 1.93]): intrapartum CS rate would increase of 6.3% points if the average number of births per delivery bed per day increased by 10%. CONCLUSION: Our results suggest that organisational norms and convenience associated with inadequate use of favourable resources, as well as the lack of privacy favouring women's preference for CS, and the excessive workload of healthcare providers drive the CS overuse in these hospitals. It is also crucial to enhance human and physical resources in delivery rooms and the organisation of intrapartum care to improve the birth experience and the working environment for those providing care. TRIAL REGISTRATION: The QUALI-DEC trial is registered on the Current Controlled Trials website ( https://www.isrctn.com/ ) under the number ISRCTN67214403.

Implementing the QUALI-DEC project in Argentina, Burkina Faso, Thailand and Viet Nam: a process delineation and theory-driven process evaluation protocol.

The project 'Quality Decision-making by women and providers' (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women's birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing.Trial registration: ISRCTN67214403.

Issues related to pregnancy, pregnancy prevention and abortion in the context of the COVID-19 pandemic: a WHO qualitative study protocol.

INTRODUCTION: WHO has generated standardised clinical and epidemiological research protocols to address key public health questions for SARS-CoV-2 (COVID-19) pandemic. We present a standardised protocol with the aim to fill a gap in understanding the needs, attitudes and practices related to sexual and reproductive health in the context of COVID-19 pandemic, focusing on pregnancy, pregnancy prevention and abortion. METHODS AND ANALYSIS PLAN: This protocol is a prospective qualitative research, using semi-structured interviews with at least 15 pregnant women at different gestational ages and after delivery, 6 months apart from the first interview. At least 10 partners, 10 non-pregnant women and 5 healthcare professionals will be interviewed once during the course of the research. Higher number of subjects may be needed if a saturation is not achieved with these numbers. Data collection will be performed in a standardised way by skilled trained interviewers using written notes or audio-record of the interview. The data will be explored using the thematic content analysis and the researchers will look for broad patterns, generalisations or theories from these categories. ETHICS AND DISSEMINATION: The current protocol was first technically assessed and approved by the WHO scientific committee and then approved by its ethics review committee as a guidance document. It is expected that each country/setting implementing such a generic protocol adapted to their conditions also obtain local ethical approval. Comments for the user's consideration are provided the document, as the user may need to modify methods slightly because of the local context in which this study will be carried out.

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation.

OBJECTIVE: To systematically develop evidence-based bundles for care of postpartum hemorrhage (PPH). METHODS: An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated "GRADE Evidence-to-Decision" framework. Twenty-three global maternal-health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6-month period, the expert panel met online and via teleconferences, culminating in a 2-day in-person meeting. RESULTS: The consultation led to the definition of two care bundles for facility implementation. The "first response to PPH bundle" comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The "response to refractory PPH bundle" comprises compressive measures (aortic or bimanual uterine compression), the non-pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements. CONCLUSION: For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.

Accuracy of angiogenic biomarkers at ⩽20weeks' gestation in predicting the risk of pre-eclampsia: A WHO multicentre study.

OBJECTIVE: To assess the accuracy of angiogenic biomarkers to predict pre-eclampsia. DESIGN: Prospective multicentre study. From 2006 to 2009, 5121 pregnant women with risk factors for pre-eclampsia (nulliparity, diabetes, previous pre-eclampsia, chronic hypertension) from Argentina, Colombia, Peru, India, Italy, Kenya, Switzerland and Thailand had their serum tested for sFlt-1, PlGF and sEng levels and their urine for PlGF levels at ⩽20, 23-27 and 32-35weeks' gestation (index tests, results blinded from carers). Women were monitored for signs of pre-eclampsia, diagnosed by systolic blood pressure ⩾140mmHg and/or diastolic blood pressure ⩾90mmHg, and proteinuria (protein/creatinine ratio ⩾0.3, protein ⩾1g/l, or one dipstick measurement ⩾2+) appearing after 20weeks' gestation. Early pre-eclampsia was defined when these signs appeared ⩽34weeks' gestation. MAIN OUTCOME MEASURE: Pre-eclampsia. RESULTS: Pre-eclampsia was diagnosed in 198 of 5121 women tested (3.9%) of whom 47 (0.9%) developed it early. The median maternal serum concentrations of index tests were significantly altered in women who subsequently developed pre-eclampsia than in those who did not. However, the area under receiver operating characteristics curve at ⩽20weeks' gestation were closer to 0.5 than to 1.0 for all biomarkers both for predicting any pre-eclampsia or at ⩽34weeks' gestation. The corresponding sensitivity, specificity and likelihood ratios were poor. Multivariable models combining sEng with clinical features slightly improved the prediction capability. CONCLUSIONS: Angiogenic biomarkers in first half of pregnancy do not perform well enough in predicting the later development of pre-eclampsia.

Obstetric transition in the World Health Organization Multicountry Survey on Maternal and Newborn Health: exploring pathways for maternal mortality reduction.

OBJECTIVE: To test whether the proposed features of the Obstetric Transition Model-a theoretical framework that may explain gradual changes that countries experience as they eliminate avoidable maternal mortality-are observed in a large, multicountry, maternal and perinatal health database; and to discuss the dynamic process of maternal mortality reduction using this model as a theoretical framework. METHODS: This was a secondary analysis of a cross-sectional study by the World Health Organization that collected information on more than 300 000 women who delivered in 359 health facilities in 29 countries in Africa, Asia, Latin America, and the Middle East, during a 2-4-month period in 2010-2011. The ratios of Potentially Life-Threatening Conditions, Severe Maternal Outcomes, Maternal Near Miss, and Maternal Death were estimated and stratified by stages of obstetric transition. The characteristics of each stage are defined. RESULTS: Data from 314 623 women showed that female fertility, indirectly estimated by parity, was higher in countries at a lower obstetric transition stage, ranging from a mean of 3 children in Stage II to 1.8 children in Stage IV. Medicalization increased with obstetric transition stage. In Stage IV, women had 2.4 times the cesarean deliveries (15.3% in Stage II and 36.7% in Stage IV) and 2.6 times the labor inductions (7.1% in Stage II and 18.8% in Stage IV) as women in Stage II. The mean age of primiparous women also increased with stage. The occurrence of uterine rupture had a decreasing trend, dropping by 5.2 times, from 178 to 34 cases per 100 000 live births, as a country transitioned from Stage II to IV. CONCLUSIONS: This analysis supports the concept of obstetric transition using multicountry data. The Obstetric Transition Model could provide justification for customizing strategies for reducing maternal mortality according to a country's stage in the obstetric transition.

Obstetric transition in the World Health Organization Multicountry Survey on Maternal and Newborn Health: exploring pathways for maternal mortality reduction / Transición obstétrica en la Encuesta Global de la Organización Mundial de la Salud sobre Salud Materna y Neonatal: exploración de las vías de reducción de la mortalidad materna

OBJECTIVE: To test whether the proposed features of the Obstetric Transition Model-a theoretical framework that may explain gradual changes that countries experience as they eliminate avoidable maternal mortality-are observed in a large, multicountry, maternal and perinatal health database; and to discuss the dynamic process of maternal mortality reduction using this model as a theoretical framework. METHODS: This was a secondary analysis of a cross-sectional study by the World Health Organization that collected information on more than 300 000 women who delivered in 359 health facilities in 29 countries in Africa, Asia, Latin America, and the Middle East, during a 2-4-month period in 2010-2011. The ratios of Potentially Life-Threatening Conditions, Severe Maternal Outcomes, Maternal Near Miss, and Maternal Death were estimated and stratified by stages of obstetric transition. The characteristics of each stage are defined. RESULTS: Data from 314 623 women showed that female fertility, indirectly estimated by parity, was higher in countries at a lower obstetric transition stage, ranging from a mean of 3 children in Stage II to 1.8 children in Stage IV. Medicalization increased with obstetric transition stage. In Stage IV, women had 2.4 times the cesarean deliveries (15.3% in Stage II and 36.7% in Stage IV) and 2.6 times the labor inductions (7.1% in Stage II and 18.8% in Stage IV) as women in Stage II. The mean age of primiparous women also increased with stage. The occurrence of uterine rupture had a decreasing trend, dropping by 5.2 times, from 178 to 34 cases per 100 000 live births, as a country transitioned from Stage II to IV. CONCLUSIONS: This analysis supports the concept of obstetric transition using multicountry data. The Obstetric Transition Model could provide justification for customizing strategies for reducing maternal mortality according to a country's stage in the obstetric transition.

RESUMEN OBJETIVO: Evaluar si las características propuestas del Modelo de Transición Obstétrica, un marco teórico que puede explicar los cambios graduales que experimentan los países a medida que eliminan la mortalidad materna evitable, se pueden observar en una amplia base de datos de salud materna y perinatal de varios países; y tratar sobre el proceso dinámico de reducción de la mortalidad materna utilizando este modelo como marco teórico. MÉTODOS: Este estudio consistió en un análisis secundario de un estudio transversal realizado por la Organización Mundial de la Salud que recopiló información sobre más de 300 000 mujeres que dieron a luz en 359 establecimientos de salud de 29 países de África, Asia, América Latina y Oriente Medio, durante un período de 2 a 4 meses en el 2010 y el 2011. Se calcularon los índices de afecciones potencialmente mortales, resultados maternos graves, morbilidad materna extremadamente grave, y muerte materna, y se estratificaron según las etapas de transición obstétrica. Se definen las características de cada etapa. RESULTADOS: Los datos de 314 623 mujeres indicaron que la fecundidad femenina, calculada indirectamente por el número de partos, fue mayor en los países que se hallaban en las primeras etapas de la transición obstétrica, desde un promedio de 3 hijos en el estadio II a 1,8 en el estadio IV. El nivel de medicalización de los establecimientos de salud de los países participantes, definido por el número de partos por cesárea y el número de partos inducidos, tuvo tendencia a aumentar según avanzaba la etapa de transición obstétrica. En el estadio IV, las mujeres tuvieron 2,4 veces más partos por cesárea (15,3% en el estadio II y 36,7% en el estadio IV) y 2,6 veces más inducciones de parto (7,1% en el estadio II y 18,8% en el estadio IV) que las mujeres en el estadio II. A medida que avanzaban las etapas de transición obstétrica, también se incrementaba la media de edad de las mujeres primíparas. La ocurrencia de rotura uterina mostraba una tendencia descendente, y se reducía 5,2 veces, de 178 a 34 casos por 100 000 nacidos vivos, a medida que un país efectuaba la transición del estadio II al IV. CONCLUSIONES: Este análisis apoya el concepto de transición obstétrica utilizando datos de varios países. El Modelo de Transición Obstétrica podría justificar la adaptación de las estrategias para reducir la mortalidad materna según la etapa de transición obstétrica en que se halla un país.

WHO multicentre study for the development of growth standards from fetal life to childhood: the fetal component.

BACKGROUND: In 2006 WHO presented the infant and child growth charts suggested for universal application. However, major determinants for perinatal outcomes and postnatal growth are laid down during antenatal development. Accordingly, monitoring fetal growth in utero by ultrasonography is important both for clinical and scientific reasons. The currently used fetal growth references are derived mainly from North American and European population and may be inappropriate for international use, given possible variances in the growth rates of fetuses from different ethnic population groups. WHO has, therefore, made it a high priority to establish charts of optimal fetal growth that can be recommended worldwide. METHODS: This is a multi-national study for the development of fetal growth standards for international application by assessing fetal growth in populations of different ethnic and geographic backgrounds. The study will select pregnant women of high-middle socioeconomic status with no obvious environmental constraints on growth (adequate nutritional status, non-smoking), and normal pregnancy history with no complications likely to affect fetal growth. The study will be conducted in centres from ten developing and industrialized countries: Argentina, Brazil, Democratic Republic of Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand. At each centre, 140 pregnant women will be recruited between 8 + 0 and 12 + 6 weeks of gestation. Subsequently, visits for fetal biometry will be scheduled at 14, 18, 24, 28, 32, 36, and 40 weeks (+/- 1 week) to be performed by trained ultrasonographers.The main outcome of the proposed study will be the development of fetal growth standards (either global or population specific) for international applications. DISCUSSION: The data from this study will be incorporated into obstetric practice and national health policies at country level in coordination with the activities presently conducted by WHO to implement the use of the Child Growth Standards.

Magnesium sulfate is not used for pre-eclampsia and eclampsia in Mexico and Thailand as much as it should be.

OBJECTIVE: In the past ten years effective treatments for pre-eclampsia and eclampsia have been evaluated and identified following large trials and systematic reviews. We investigated the extent of those effective interventions implementation. METHODS: Descriptive analysis of data collected as part of a cluster randomized trial. The trial was assigned the International Standardised Randomized Controlled Trial Number ISRCTN 14055385. Hospitals with more than 1000 deliveries per year not directly associated with an academic institution in Mexico City municipal area in Mexico (n = 22) and the north-east region of Thailand (n = 18) were included. All women delivering at the participating hospitals at two time periods in 2000 and 2002 contributed data on practice rates. The use of magnesium sulfate for pre-eclampsia and eclampsia were the outcomes. FINDINGS: Eight out of 22 hospitals in Mexico (range 0.8% to 8.5%) and all 18 hospitals in Thailand (range 18.6% to 63.6%) used magnesium sulfate for women with pre-eclampsia. In Mexico, 11 of 22 hospitals used magnesium sulfate for eclampsia (range 9.1% to 60.0%). In Thailand, all 17 hospitals having eclampsia cases used magnesium sulfate (range 25% to 100%). CONCLUSION: Despite compelling evidence, magnesium sulfate use is below desired levels. Clinical practices should be audited and implementation of this effective intervention should be taken up as a priority where universal implementation is not in place.

Cluster randomized trial of an active, multifaceted information dissemination intervention based on The WHO Reproductive health library to change obstetric practices: methods and design issues [ISRCTN14055385].

BACKGROUND: Effective strategies for implementing best practices in low and middle income countries are needed. RHL is an annually updated electronic publication containing Cochrane systematic reviews, commentaries and practical recommendations on how to implement evidence-based practices. We are conducting a trial to evaluate the improvement in obstetric practices using an active dissemination strategy to promote uptake of recommendations in The WHO Reproductive Health Library (RHL). METHODS: A cluster randomized trial to improve obstetric practices in 40 hospitals in Mexico and Thailand is conducted. The trial uses a stratified random allocation based on country, size and type of hospitals. The core intervention consists of three interactive workshops delivered over a period of six months. The main outcome measures are changes in clinical practices that are recommended in RHL measured approximately a year after the first workshop. RESULTS: The design and implementation of a complex intervention using a cluster randomized trial design are presented. CONCLUSION: Designing the intervention, choosing outcome variables and implementing the protocol in two diverse settings has been a time-consuming and challenging process. We hope that sharing this experience will help others planning similar projects and improve our ability to implement change.

Womens' opinions on antenatal care in developing countries: results of a study in Cuba, Thailand, Saudi Arabia and Argentina.

BACKGROUND: The results of a qualitative study carried out in four developing countries (Cuba, Thailand, Saudi Arabia and Argentina) are presented. The study was conducted in the context of a randomised controlled trial to test the benefits of a new antenatal care protocol that reduced the number of visits to the doctor, rationalised the application of technology, and improved the provision of information to women in relation to the traditional protocol applied in each country. METHODS: Through focus groups discussions we were able to assess the concepts and expectations underlying women's evaluation of concepts and experiences of the care received in antenatal care clinics. 164 women participated in 24 focus groups discussion in all countries. RESULTS: Three areas are particularly addressed in this paper: a) concepts about pregnancy and health care, b) experience with health services and health providers, and c) opinions about the modified Antenatal Care (ANC) programme. In all three topics similarities were identified as well as particular opinions related to country specific social and cultural values. In general women have a positive view of the new ANC protocol, particularly regarding the information they receive. However, controversial issues emerged such as the reduction in the number of visits, particularly in Cuba where women are used to have 18 ANC visits in one pregnancy period. CONCLUSION: Recommendations to improve ANC services performance are being proposed. Any country interested in the application of a new ANC protocol should regard the opinion and acceptability of women towards changes.

Are women and providers satisfied with antenatal care? Views on a standard and a simplified, evidence-based model of care in four developing countries.

BACKGROUND: This study assessed women and providers' satisfaction with a new evidence-based antenatal care (ANC) model within the WHO randomized trial conducted in four developing countries. The WHO study was a randomized controlled trial that compared a new ANC model with the standard type offered in each country. The new model of ANC emphasized actions known to be effective in improving maternal or neonatal health, excluded other interventions that have not proved to be beneficial, and improved the information component, especially alerting pregnant women to potential health problems and instructing them on appropriate responses. These activities were distributed within four antenatal care visits for women that did not need any further assessment. METHODS: Satisfaction was measured through a standardized questionnaire administered to a random sample of 1,600 pregnant women and another to all antenatal care providers. RESULTS: Most women in both arms expressed satisfaction with ANC. More women in the intervention arm were satisfied with information on labor, delivery, family planning, pregnancy complications and emergency procedures. More providers in the experimental clinics were worried about visit spacing, but more satisfied with the time spent and information provided. CONCLUSIONS: Women and providers accepted the new ANC model generally. The safety of fewer visits for women without complications with longer spacing would have to be reinforced, if such a model is to be introduced into routine practice.