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On the continuum of maternal health care, two extreme situations exist: too little, too late (TLTL) and too much, too soon (TMTS). TLTL describes care with inadequate resources, below evidence-based standards, or care withheld or unavailable until too late to help. TLTL is an underlying problem associated with high maternal mortality and morbidity. TMTS describes the routine over-medicalisation of normal pregnancy and birth. TMTS includes unnecessary use of non-evidence-based interventions, as well as use of interventions that can be life saving when used appropriately, but harmful when applied routinely or overused. As facility births increase, so does the recognition that TMTS causes harm and increases health costs, and often concentrates disrespect and abuse. Although TMTS is typically ascribed to high-income countries and TLTL to low-income and middle-income ones, social and health inequities mean these extremes coexist in many countries. A global approach to quality and equitable maternal health, supporting the implementation of respectful, evidence-based care for all, is urgently needed. We present a systematic review of evidence-based clinical practice guidelines for routine antenatal, intrapartum, and postnatal care, categorising them as recommended, recommended only for clinical indications, and not recommended. We also present prevalence data from middle-income countries for specific clinical practices, which demonstrate TLTL and increasing TMTS. Health-care providers and health systems need to ensure that all women receive high-quality, evidence-based, equitable and respectful care. The right amount of care needs to be offered at the right time, and delivered in a manner that respects, protects, and promotes human rights.

Introduction Our objective was to evaluate whether antihypertensives affect fetal (FHR) or neonatal (neoHR) heart rate. Material and methods Electronic databases and clinical trial registers were searched to August 31, 2024. Eligibility included randomized (RCTs) or observational studies evaluating antihypertensives for pregnancy hypertension. Two reviewers independently assessed studies for inclusion and extracted data. Random effects meta‐analysis was used to determine risk ratios (RRs) and 95% confidence intervals (CIs). Network meta‐analysis was undertaken in a sensitivity analysis. Results Fifty‐four RCTs (n = 5736 pregnancies) and 28 observational studies (n = 2 283 855) reported FHR (usually visually‐interpreted) or neoHR (usually clinically‐assessed). FHR: Non‐Severe Hypertension Antihypertensives did not increase adverse FHR effects in RCTs of antihypertensives versus placebo/no therapy (RR = 1.08, 95% CI [0.62–1.89]; I2 = 43%; N = 10, n = 1567 pregnancies), antihypertensives versus methyldopa (RR = 1.40 [0.97–2.04]; I2 = 0%; N = 6, n = 515), or labetalol or pure beta‐blockers versus other antihypertensives (RR = 1.70 [0.96–2.99]; I2 = 30%; N = 5, n = 501). In observational studies, adverse FHR effects were more common with: labetalol versus methyldopa, nifedipine or Chinese herbal medication (RR = 2.17 [1.15–4.08]; I2 = 47%; N = 4, n = 664), and bendroflumethiazide versus metoprolol (but not hydralazine), but 95% CIs were wide. FHR: Severe Hypertension Antihypertensives had no FHR effects in RCTs of antihypertensives versus either: placebo/no therapy (RR = 0.43 [0.16–1.20]; I2 = 0%; N = 3, n = 242), hydralazine (RR = 0.71 [0.29–1.72]; I2 = 13%; N = 11, n = 727), or CCBs (RR = 0.52 [0.12–2.16]; I2 = 0%, N = 9, n = 1675). In observational studies, there was no difference for labetalol versus other antihypertensives (RR = 0.34 [0.10–1.14], I2 = 87%; N = 4, n = 590), with heterogeneity due to a lower‐quality labetalol versus hydralazine study. There were fewer adverse FHR effects for nifedipine versus hydralazine study (RR = 0.09 [0.01–0.68]; n = 49). NeoHR: Severe Hypertension RCTs of antihypertensives versus placebo/no therapy were not associated with adverse neoHR effects (RR = 1.26 [0.31–5.19]; I2 = 66%; N = 4, n = 406), with heterogeneity attributed to more neoHR effects with continuously monitored neoHR. Observational studies revealed no effect on neoHR of antihypertensives versus no therapy (RR = 1.06 [0.67–1.67]; I2 = 54%; N = 4, n = 37 359), but labetalol was associated with more adverse effects and metoprolol with fewer. In RCTs of antihypertensives versus other antihypertensives, there was no difference in adverse neoHR (RR = 3.0 [0.13–71.74]; N = 3, n = 162). Observational studies showed adverse neoHR effects in labetalol versus pure beta‐blockers (RR = 1.99 [1.36–2.91]; I2 = 0%; N = 3, n = 16 204). No severe hypertension RCTs reported neoHR. Observational studies were limited. Network meta‐analysis showed no significant relationships between antihypertensives and FHR or neoHR; 95% CIs were very wide. Conclusions Evidence is inadequate to draw reliable conclusions about the impact of antihypertensives on FHR or neoHR. At present, adverse FHR or neoHR effects should be attributed to evolving placental dysfunction. Trials are mostly reassuring regarding antihypertensive effects on fetal (FHR) or neonatal heart rate (neoHR), but observational studies raise concerns about beta‐blockers, particularly the alpha/beta‐blocker labetalol. Clinicians should ascribe adverse fetal or neonatal heart rate effects to evolving underlying placental dysfunction or newborn illness, respectively, and not to antihypertensive therapy.

Classification of the hypertensive disorders of pregnancy Gestational hypertension (pregnancy induced hypertension) Hypertension detected for the first time after 20 weeks' gestation, in the absence of proteinuria Hypertension defined as systolic blood pressure â[per thousand]¥ 140 mm Hg or diastolic blood pressure â[per thousand]¥ 90 mm Hg Resolves within three months after the birth Pre-eclampsia and eclampsia Hypertension and proteinuria detected for the first time after 20 weeks' gestation Hypertension defined as above Proteinuria defined as â[per thousand]¥ 300 mg/day or â[per thousand]¥ 30 mg/mmol in a single specimen or â[per thousand]¥ 1+ ondipstick Eclampsia is the occurrence of seizures superimposedon the syndrome of pre-eclampsia Chronic hypertension Hypertension known to be present before pregnancy or detected before 20 weeks' gestation \"Essential\" hypertension if there is no underlyingcause \"Secondary\" hypertension if associated with underlyingdisease Pre-eclampsia superimposed on chronic hypertension Onset of new signs or symptoms of pre-eclampsia after 20 weeks' gestation in a woman with chronic hypertension If possible, proteinuria should be confirmed in a 24 hour collection. Includes explanations of the role of systematic reviews, and chapters on pre-eclampsia NHS Direct ( http://www.nhsdirect.nhs.uk )-Informationand advice from the UK National Health Service Prevention of eclampsia There is now robust evidence that, for women with pre-eclampsia, magnesium sulphate more than halves the risk of eclampsia (number needed to treat 100, 95% confidence interval 50 to 100) and probably reduces the risk of maternal death (fig D on bmj.com ).

BackgroundKnowledge translation (KT) approaches have been advocated to increase uptake of evidence to improve maternal health outcomes in low- and middle-income countries (LMICs). However, their use is limited by lack of KT capacity and limited applicability of many existing KT tools to the unique challenges of LMIC health settings. We developed and evaluated a toolkit designed for use by non-experts and tailored to support implementation planning in LMICs.MethodBased on our prior research which identified common implementation barriers across five LMICs, a literature review and a qualitative study with women and families in two LMICs, we developed a preliminary item list. Through consultation with our international partners, the item list was refined, a draft toolkit developed and usability tested.Pilot evaluation of the toolkit employed observation and focus groups with participants at implementation planning meetings conducted in Argentina and Ghana, focused on locally identified evidence-based maternal health implementation priorities.Results31 interested parties participated, 10 in Argentina and 21 in Ghana, representing a range of roles relevant to implementation in the local contexts including providers, health educators, policy/decision makers, researchers and patients/patient representatives. Participants reported a number of benefits to the content and organisation of both the toolkit and meeting format, which they noted encouraged open exchange of perspectives and experiences, and comprehensive consideration and discussion of barriers and facilitators (BFs) to implementation in their context. Minor changes to the instructions and wording of a few BFs were suggested and incorporated.ConclusionThe toolkit provides a resource to support LMIC maternal health implementers by offering a structured approach to assessment and ranking of BFs to implementation and a guide to mapping BFs to evidence-based implementation strategies. Further evaluation across a wider range of health topics and LMICs and in low-resource contexts in high-income countries is needed.Study registrationOpen Science Framework https://osf.io/328dy Registered 31 May 2023.

In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.

ObjectivesDaily calcium supplements are recommended for pregnant women from 20 weeks’ gestation to prevent pre-eclampsia in populations with low dietary calcium intake. We aimed to improve understanding of barriers and facilitators for calcium supplement intake during pregnancy to prevent pre-eclampsia.DesignMixed-method systematic review, with confidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative research approach.Data sourcesMEDLINE and EMBASE (via Ovid), CINAHL and Global Health (via EBSCO) and grey literature databases were searched up to 17 September 2022.Eligibility criteriaWe included primary qualitative, quantitative and mixed-methods studies reporting implementation or use of calcium supplements during pregnancy, excluding calcium fortification and non-primary studies. No restrictions were imposed on settings, language or publication date.Data extraction and synthesisTwo independent reviewers extracted data and assessed risk of bias. We analysed the qualitative data using thematic synthesis, and quantitative findings were thematically mapped to qualitative findings. We then mapped the results to behavioural change frameworks to identify barriers and facilitators.ResultsEighteen reports from nine studies were included in this review. Women reported barriers to consuming calcium supplements included limited knowledge about calcium supplements and pre-eclampsia, fears and experiences of side effects, varying preferences for tablets, dosing, working schedules, being away from home and taking other supplements. Receiving information regarding pre-eclampsia and safety of calcium supplement use from reliable sources, alternative dosing options, supplement reminders, early antenatal care, free supplements and support from families and communities were reported as facilitators. Healthcare providers felt that consistent messaging about benefits and risks of calcium, training, and ensuring adequate staffing and calcium supply is available would be able to help them in promoting calcium.ConclusionRelevant stakeholders should consider the identified barriers and facilitators when formulating interventions and policies on calcium supplement use. These review findings can inform implementation to ensure effective and equitable provision and scale-up of calcium interventions.PROSPERO registration numberCRD42021239143.

Introduction A generic research protocol was developed for a prospective cohort study to allow systematic, harmonized data collection of the impact of SARS-CoV-2 infection and vaccination during pregnancy on maternal, obstetric, and neonatal outcomes across different settings. This article describes the study conception, development, implementation, challenges, and key lessons learned within study sites across the world. Methods The protocol was implemented in 43 facilities in 10 countries during the pandemic, involving consecutive recruitment of over 16,000 pregnant or postpartum women. We evaluated selection of study sites, ethical approvals, staff recruitment and training, recruitment and follow-up, and incorporation of new elements over the course of the pandemic across the study sites. Results Study implementation in multiple LMIC settings was feasible; however, major challenges included delays in study implementation due to ethical approval procedures and availability of testing for exposure assessment. Implementation of research during a constantly evolving pandemic context led to the need for amended protocols, adjusted sample sizes, new outcomes and variables, repeated review by the Ethical Committees and adapted laboratory protocols. For example, the first COVID-19 vaccines became available after the study had started, with the need to modify the data collection forms and serologic testing algorithm to allow incorporation of this information in the study structure and analysis. Conclusion Study implementation during a pandemic in different countries and periods was challenging but is not only expected to provide important information on the effects of SARS-CoV-2 infection and vaccination on pregnancy, but also on conducting research during future outbreaks. More streamlined ethics reviews during pandemics, availability of generic protocols in advance, and sites in LMICs ready to activate in an outbreak, as opposed to triggering processes during a crisis, would be highly beneficial.

IntroductionLow dietary calcium intake is a risk factor for pre-eclampsia, a major contributor to maternal and perinatal mortality and morbidity worldwide. Calcium supplementation can prevent pre-eclampsia in women with low dietary calcium. However, the optimal dose and timing of calcium supplementation are not known. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to determine the effects of various calcium supplementation regimens in preventing pre-eclampsia and its complications and rank these by effectiveness. We also aim to evaluate the cost-effectiveness of calcium supplementation to prevent pre-eclampsia.Methods and analysisWe will identify randomised trials on calcium supplementation before and during pregnancy by searching major electronic databases including Embase, CINAHL, MEDLINE, CENTRAL, PubMed, Scopus, AMED, LILACS, POPLINE, AIM, IMSEAR, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform, without language restrictions, from inception to February 2022. Primary researchers of the identified trials will be invited to join the International Calcium in Pregnancy Collaborative Network and share their IPD. We will check each study’s IPD for consistency with the original authors before standardising and harmonising the data. We will perform a series of one-stage and two-stage IPD random-effect meta-analyses to obtain the summary intervention effects on pre-eclampsia with 95% CIs and summary treatment–covariate interactions (maternal risk status, dietary intake, timing of intervention, daily dose of calcium prescribed and total intake of calcium). Heterogeneity will be summarised using tau2, I2 and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Minor study effects (potential publication bias) will be investigated using funnel plots. A decision analytical model for use in low-income and middle-income countries will assess the cost-effectiveness of calcium supplementation to prevent pre-eclampsia.Ethics and disseminationNo ethical approvals are required. We will store the data in a secure repository in an anonymised format. The results will be published in peer-reviewed journals.PROSPERO registration numberCRD42021231276.

IntroductionCOVID-19 is associated with higher morbimortality in pregnant people compared with non-pregnant people. At present, the benefits of maternal immunisation are considered to outweigh the risks, and therefore, vaccination is recommended during pregnancy. However, additional information is needed on the safety of the vaccines in this population.Methods and analysisThis a retrospective cohort nested case–control study in pregnant people who attended maternity hospitals from eight Latin American and Caribbean countries. A perinatal electronic clinical history database with neonatal and obstetric information will be used. The proportion of pregnant people immunised with COVID-19 vaccines of the following maternal and neonatal events will be described: preterm infant, small for gestational age, low birth weight, stillbirth, neonatal death, congenital malformations, maternal near miss and maternal death. Moreover, the risk of prematurity, small for gestational age and low birth weight associated with exposure to COVID-19 vaccines will be estimated. Each case will be matched with two groups of three randomly selected controls. Controls will be matched by hospital and mother’s age (±3 years) with an additional matching by delivery date and conception time in the first and second control groups, respectively. The estimated required sample size for the main analysis (exposure to any vaccine) concerning ‘non-use’ is at least 1009 cases (3027 controls) to detect an increased probability of vaccine-associated event risk of 30% and at least 650 cases (1950 controls) to detect 30% protection. Sensitivity and secondary analyses considering country, type of vaccine, exposure windows and completeness of immunisation will be reported.EthicsThe study protocol was reviewed by the Ethical Review Committee on Research of the Pan American Health Organization. Patient informed consent was waived due to the retrospective design and the utilisation of anonymised data (Ref. No: PAHOERC.0546.01). Results will be disseminated in open access journals.

To describe how the SUPPORT collaboration developed a short summary format for presenting the results of systematic reviews to policy-makers in low- and middle-income countries (LMICs). We carried out 21 user tests in six countries to explore users' experiences with the summary format. We modified the summaries based on the results and checked our conclusions through 13 follow-up interviews. To solve the problems uncovered by the user testing, we also obtained advisory group feedback and conducted working group workshops. Policy-makers liked a graded entry format (i.e. short summary with key messages up front). They particularly valued the section on the relevance of the summaries for LMICs, which compensated for the lack of locally-relevant detail in the original review. Some struggled to understand the text and numbers. Three issues made redesigning the summaries particularly challenging: (i) participants had a poor understanding of what a systematic review was; (ii) they expected information not found in the systematic reviews and (iii) they wanted shorter, clearer summaries. Solutions included adding information to help understand the nature of a systematic review, adding more references and making the content clearer and the document quicker to scan. Presenting evidence from systematic reviews to policy-makers in LMICs in the form of short summaries can render the information easier to assimilate and more useful, but summaries must be clear and easy to read or scan quickly. They should also explain the nature of the information provided by systematic reviews and its relevance for policy decisions.