Clinical algorithms for the monitoring and management of spontaneous, uncomplicated labour and childbirth.

The aim of this manuscript is to develop evidence-based clinical algorithms for the assessment and management of spontaneous, uncomplicated labour and vaginal birth. The population is pregnant women at any stage of labour, with singleton, term pregnancies considered to be at low risk of developing complications in health facilities in low and middle income countries. We searched for relevant published algorithms, guidelines, systematic reviews and primary research studies on Cochrane Library, PubMed® and Google, using terms related to spontaneous, uncomplicated labour and childbirth up to 1 June 2023. Three case scenarios were developed to cover the assessment and management of spontaneous, uncomplicated first, second and third stages of labour. The algorithms provide pathways for definition, assessments, diagnosis and links to other algorithms in this series for the management of complications. We have developed three clinical algorithms to support evidence-based decision-making during spontaneous, uncomplicated labour and vaginal birth. These algorithms may help to guide healthcare staff to institute respectful care, with appropriate interventions where needed, and potentially will reduce the unnecessary use of interventions during labour and childbirth.

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.

Optimizing the use of cesarean section in Argentina: design and methodology of a formative research for the development of interventions.

BACKGROUND: While cesarean section is an essential life-saving strategy for women and newborns, its current overuse constitutes a global problem. The aim of this formative research is to collect information from hospitals, health professionals and women regarding the use of cesarean section in Argentina. This article describes the methodology of the study, the characteristics of the hospitals and the profile of the participants. METHODS: This formative research is a mixed-method study that will be conducted in seven provinces of Argentina. The eligibility criteria for the hospitals are (a) use of the Perinatal Information System, (b) cesarean section rate higher than 27% in 2016, (c) ≥ 1000 deliveries per year. Quantitative and qualitative research techniques will be used for data collection and analysis. The main inquiry points are the determining factors for the use of cesarean section, the potential interventions to optimize the use of cesarean section and, in the case of women, their preferred type of delivery. DISCUSSION: It is expected that the findings will provide a situation diagnosis to help a context-sensitive implementation of the interventions recommended by the World Health Organization to optimize cesarean section use. Trial registration IS002316 Cesarean section is an essential medical tool for mothers and their children, but nowadays its overuse is a problem worldwide. Our purpose is to get information from hospitals, health professionals and women about how cesarean section is used in Argentina. In this protocol we describe how we will carry out the study and the characteristics of the hospitals and participants. We will implement this study in seven provinces of Argentina, in hospitals that have more than 1,000 births each year, had a cesarean section rate higher than 27% in 2016 and use the Perinatal Information System. We will gather information using forms, surveys and interviews. We want to identify the factors that decide the use of a cesarean section, the potential interventions that can improve the use of cesarean section and, in the case of women, the type of delivery they prefer. We expect that this study will give us a diagnosis of how cesarean section is used in Argentina, and that this will help to apply the interventions that the World Health Organization recommends to optimize the use of cesarean section in our specific context.

RESUMEN: INTRODUCCIóN: Aun cuando la cesárea es una intervención que puede ser esencial para salvar la vida de una mujer y su hijo, el crecimiento excesivo de su uso  es un problema global. El propósito de esta investigación formativa es recolectar información sobre las instituciones, profesionales de la salud y mujeres acerca del uso de la cesárea en la Argentina. Este artículo describe la metodología del estudio, las características de los hospitales y el perfil de los participantes. METODOLOGíA: Esta investigación formativa usa un diseño mixto aplicado en siete provincias del país. Los criterios de elegibilidad para los hospitales son: (a) uso del Sistema Informático Perinatal, (b) tasa de cesáreas mayor al 27% en 2016, y (c) ≥ 1000 partos por año. Se usarán técnicas cualitativas y cuantitativas para la recolección de datos y el análisis. Los principales temas a indagar son los determinantes del uso de la cesárea, las intervenciones para optimizar su uso y, en el caso de las mujeres, sus preferencias sobre el modo de parto. DISCUSIóN: Se espera que los resultados den lugar a un diagnóstico de situación que permita una implementación de las intervenciones propuesas por la OMS para optimizar el uso de la cesárea más ajustada al contexto. Registro del estudio IS002316.

Antihypertensive drug therapy for mild to moderate hypertension during pregnancy.

BACKGROUND: Antihypertensive drugs are often used in the belief that lowering blood pressure will prevent progression to more severe disease, and thereby improve pregnancy outcome. This Cochrane Review is an updated review, first published in 2001 and subsequently updated in 2007 and 2014. OBJECTIVES: To assess the effects of antihypertensive drug treatments for women with mild to moderate hypertension during pregnancy. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (13 September 2017), and reference lists of retrieved studies. SELECTION CRITERIA: All randomised trials evaluating any antihypertensive drug treatment for mild to moderate hypertension during pregnancy, defined as systolic blood pressure 140 to 169 mmHg and/or diastolic blood pressure 90 to 109 mmHg. Comparisons were of one or more antihypertensive drug(s) with placebo, with no antihypertensive drug, or with another antihypertensive drug, and where treatment was planned to continue for at least seven days. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: For this update, we included 63 trials (data from 58 trials, 5909 women), with moderate to high risk of bias overall.We carried out GRADE assessments for the main 'antihypertensive drug versus placebo/no antihypertensive drug' comparison only. Evidence was graded from very low to moderate certainty, with downgrading mainly due to design limitations and imprecision.For many outcomes, trials contributing data evaluated different hypertensive drugs; while we did not downgrade for this indirectness, results should be interpreted with caution.Antihypertensive drug versus placebo/no antihypertensive drug (31 trials, 3485 women)Primary outcomes: moderate-certainty evidence suggests that use of antihypertensive drug(s) probably halves the risk of developing severe hypertension (risk ratio (RR) 0.49; 95% confidence interval (CI) 0.40 to 0.60; 20 trials, 2558 women), but may have little or no effect on the risk of proteinuria/pre-eclampsia (average risk ratio (aRR) 0.92; 95% CI 0.75 to 1.14; 23 trials, 2851 women; low-certainty evidence). Moderate-certainty evidence also shows that antihypertensive drug(s) probably have little or no effect in the risk of total reported fetal or neonatal death (including miscarriage) (aRR 0.72; 95% CI 0.50 to 1.04; 29 trials, 3365 women), small-for-gestational-age babies (aRR 0.96; 95% CI 0.78 to 1.18; 21 trials, 2686 babies) or preterm birth less than 37 weeks (aRR 0.96; 95% CI 0.83 to 1.12; 15 trials, 2141 women). SECONDARY OUTCOMES: we are uncertain of the effect of antihypertensive drug(s) on the risk of maternal death, severe pre-eclampsia, or eclampsia, orimpaired long-term growth and development of the baby in infancy and childhood, because the certainty of this evidence is very low. There may be little or no effect on the risk of changed/stopped drugs due to maternal side-effects, or admission to neonatal or intensive care nursery (low-certainty evidence). There is probably little or no difference in the risk of elective delivery (moderate-certainty evidence).Antihypertensive drug versus another antihypertensive drug (29 trials, 2774 women)Primary outcomes: beta blockers and calcium channel blockers together in the meta-analysis appear to be more effective than methyldopa in avoiding an episode of severe hypertension (RR 0.70; 95% CI 0.56 to 0.88; 11 trials, 638 women). There was also an increase in this risk when other antihypertensive drugs were compared with calcium channel blockers (RR 1.86; 95% CI 1.09 to 3.15; 5 trials, 223 women), but no evidence of a difference when methyldopa and calcium channel blockers together were compared with beta blockers (RR1.18, 95% CI 0.95 to 1.48; 10 trials, 692 women). No evidence of a difference in the risk of proteinuria/pre-eclampsia was found when alternative drugs were compared with methyldopa (aRR 0.78; 95% CI 0.58 to 1.06; 11 trials, 997 women), with calcium channel blockers (aRR: 1.24, 95% CI 0.70 to 2.19; 5 trials, 375 women), or with beta blockers (aRR 1.21, 95% CI 0.88 to 1.67; 12 trials, 1107 women).For the babies, we found no evidence of a difference in the risk oftotal reported fetal or neonatal death (including miscarriage) when comparing other antihypertensive drugs with methyldopa (aRR 0.77, 95% CI 0.52 to 1.14; 22 trials, 1791 babies), with calcium channel blockers (aRR 0.90, 95% CI 0.52 to 1.57; nine trials, 700 babies), or with beta blockers (aRR: 1.23, 95% CI 0.81 to 1.88; 19 trials, 1652 babies); nor in the risk for small-for-gestational age in the comparison with methyldopa (aRR 0.79, 95% CI 0.52 to 1.20; seven trials, 597 babies), with calcium channel blockers (aRR 1.05, 95% CI 0.64 to 1.73; four trials, 200 babies), or with beta blockers (average RR 1.13, 95% CI 0.80 to 1.60; 7 trials, 680 babies). No evidence of an overall difference among groups in the risk of preterm birth (less than 37 weeks) was found in the comparison with methyldopa (aRR: 0.91; 95% CI 0.68 to 1.22; 11 trials, 835 women), with calcium channel blockers (aRR 0.85, 95% CI 0.59 to 1.23; six trials, 330 women), or with beta blockers (aRR 1.22, 95% CI 0.90 to 1.66; 9 trials, 806 women). SECONDARY OUTCOMES: There were no cases of maternal death andeclampsia. There is no evidence of a difference in the risk of severe pre-eclampsia, changed/stopped drug due to maternal side-effects, elective delivery, admission to neonatal or intensive care nursery when other antihypertensive drugs are compared with methyldopa, calcium channel blockers or beta blockers. Impaired long-term growth and development in infancy and childhood was not reported for these comparisons. AUTHORS' CONCLUSIONS: Antihypertensive drug therapy for mild to moderate hypertension during pregnancy reduces the risk of severe hypertension. The effect on other clinically important outcomes remains unclear. If antihypertensive drugs are used, beta blockers and calcium channel blockers appear to be more effective than the alternatives for preventing severe hypertension. High-quality large sample-sized randomised controlled trials are required in order to provide reliable estimates of the benefits and adverse effects of antihypertensive treatment for mild to moderate hypertension for both mother and baby, as well as costs to the health services, women and their families.

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.

Evidence-based surgical procedures to optimize caesarean outcomes: an overview of systematic reviews.

Background: Caesarean section (CS) is the most performed major surgery worldwide. Surgical techniques used for CS vary widely and there is no internationally accepted standardization. We conducted an overview of systematic reviews (SR) of randomized controlled trials (RCT) to summarize the evidence on surgical techniques or procedures related to CS. Methods: Searches were conducted from database inception to 31 January 2024 in Cochrane Database of Systematic Reviews, PubMed, EMBASE, Lilacs and CINAHL without date or language restrictions. AMSTAR 2 and GRADE were used to assess the methodological quality of the SRs and the certainty of evidence at outcome level, respectively. We classified each procedure-outcome pair into one of eight categories according to effect estimates and certainty of evidence. The overview was registered at PROSPERO (CRD 42023208306). Findings: The analysis included 38 SRs (16 Cochrane and 22 non-Cochrane) published between 2004-2024 involving 628 RCT with a total of 190,349 participants. Most reviews were of low or critically low quality (AMSTAR 2). The SRs presented 345 procedure-outcome comparisons (237 procedure versus procedure, 108 procedure versus no treatment/placebo). There was insufficient or inconclusive evidence for 256 comparisons, clear evidence of benefit for 40, possible benefit for 17, no difference of effect for 13, clear evidence of harm for 14, and possible harm for 5. We found no SRs for 7 pre-defined procedures. Skin cleansing with chlorhexidine, Joel-Cohen-based abdominal incision, uterine incision with blunt dissection and cephalad-caudal expansion, cord traction for placental extraction, manual cervical dilatation in pre-labour CS, changing gloves, chromic catgut suture for uterine closure, non-closure of the peritoneum, closure of subcutaneous tissue, and negative pressure wound therapy are procedures associated with benefits for relevant outcomes. Interpretation: Current evidence suggests that several CS surgical procedures improve outcomes but also reveals a lack of or inconclusive evidence for many commonly used procedures. There is an urgent need for evidence-based guidelines standardizing techniques for CS, and trials to fill existing knowledge gaps. Funding: UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO).

Multicountry research on comprehensive abortion policy implementation in Latin America: a mixed-methods study protocol.

INTRODUCTION: Access to comprehensive abortion care could prevent the death of between 13 865 and 38 940 women and the associated morbidity of 5 million women worldwide. There have been some important improvements in Latin America in terms of laws and policies on abortion. However, the predominant environment is still restrictive, and many women, adolescents and girls still face multiple barriers to exercise their reproductive rights. This research will systematically assess comprehensive abortion policies in five Latin American countries (Argentina, Colombia, Honduras, Mexico and Uruguay). The aim is to identify barriers, facilitators and strategies to the implementation of abortion policies, looking at four key dimensions-regulatory framework, abortion policy dynamics, abortion service delivery and health system and health outcomes indicators-to draw cross-cutting lessons learnt to improve current implementation and inform future safe abortion policy development. METHODS AND ANALYSIS: A mixed-method design will be used in the five countries to address the four dimensions through the Availability, Accessibility, Acceptability and Quality of Care model. The data collection tools include desk reviews and semi-structured interviews with key actors. Analysis will be performed using thematic analysis and stakeholder analysis. A regional synthesis exercise will be conducted to draw lessons on barriers, facilitators and the strategies. ETHICS AND DISSEMINATION: The project has been approved by the WHO Research Ethics Review Committee (ID: A66023) and by the local research ethics committees. Informed consent will be obtained from participants. Data will be treated with careful attention to protecting privacy and confidentiality. Findings from the study will be disseminated through a multipurpose strategy to target diverse audiences to foster the use of the study findings to inform the public debate agenda and policy implementation at national level. The strategy will include academic, advocacy and policy arenas and actors, including peer-reviewed publication and national and regional dissemination workshops.

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.

Caesarean birth in public maternities in Argentina: a formative research study on the views of obstetricians, midwives and trainees.

OBJECTIVES: To explore obstetricians', midwives' and trainees' perceptions of caesarean section (CS) determinants in the context of public obstetric care services provision in Argentina. Our hypothesis is that known determinants of CS use may differ in settings with limited access to essential obstetric services. SETTING: We conducted a formative research study in 19 public maternity hospitals in Argentina. An institutional survey assessed the availability of essential obstetric services. Subsequently, we conducted online surveys and semistructured interviews to assess the opinions of providers on known CS determinants. RESULTS: Obstetric services showed an adequate provision of emergency obstetric care but limited services to support women during birth. Midwives, with some exceptions, are not involved during labour. We received 680 surveys from obstetricians, residents and midwives (response rate of 63%) and interviewed 26 key informants. Six out of 10 providers (411, 61%) indicated that the use of CS is associated with the complexities of our caseload. Limited pain management access was deemed a potential contributing factor for CS in adolescents and first-time mothers. Providers have conflicting views on the adequacy of training to deal with complex or prolonged labour. Obstetricians with more than 10 years of clinical experience indicated that fear of litigation was also associated with CS. Overall, there is consensus on the need to implement interventions to reduce unnecessary CS. CONCLUSIONS: Public maternity hospitals in Argentina have made significant improvements in the provision of emergency services. The environment of service provision does not seem to facilitate the physiological process of vaginal birth. Providers acknowledged some of these challenges.

Caesarean section or vaginal delivery for low-risk pregnancy? Helping women make an informed choice in low- and middle-income countries.

Women's fear and uncertainty about vaginal delivery and lack of empowerment in decision-making generate decision conflict and is one of the main determinants of high caesarean section rates in low- and middle-income countries (LMICs). This study aims to develop a decision analysis tool (DAT) to help pregnant women make an informed choice about the planned mode of delivery and to evaluate its acceptability in Vietnam, Thailand, Argentina, and Burkina Faso. The DAT targets low-risk pregnant women with a healthy, singleton foetus, without any medical or obstetric disorder, no previous caesarean scarring, and eligibility for labour trials. We conducted a systematic review to determine the short- and long-term maternal and offspring risks and benefits of planned caesarean section compared to planned vaginal delivery. We carried out individual interviews and focus group discussions with key informants to capture informational needs for decision-making, and to assess the acceptability of the DAT in participating hospitals. The DAT meets 20 of the 22 Patient Decision Aid Standards for decision support. It includes low- to moderate-certainty evidence-based information on the risks and benefits of both modes of birth, and helps pregnant women clarify their personal values. It has been well accepted by women and health care providers. Adaptations have been made in each country to fit the context and to facilitate its implementation in current practice, including the development of an App. DAT is a simple method to improve communication and facilitate shared decision-making for planned modes of birth. It is expected to build trust and foster more effective, satisfactory dialogue between pregnant women and providers. It can be easily adapted and updated as new evidence emerges. We encourage further studies in LMICs to assess the impact of DAT on quality decision-making for the appropriate use of caesarean section in these settings.