External validation of prognostic models predicting pre-eclampsia : individual participant data meta-analysis

Abstract Background Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk during pregnancy is required to plan management. Although there are many published prediction models for pre-eclampsia, few have been validated in external data. Our objective was to externally validate published prediction models for pre-eclampsia using individual participant data (IPD) from UK studies, to evaluate whether any of the models can accurately predict the condition when used within the UK healthcare setting. Methods IPD from 11 UK cohort studies (217,415 pregnant women) within the International Prediction of Pregnancy Complications (IPPIC) pre-eclampsia network contributed to external validation of published prediction models, identified by systematic review. Cohorts that measured all predictor variables in at least one of the identified models and reported pre-eclampsia as an outcome were included for validation. We reported the model predictive performance as discrimination (C-statistic), calibration (calibration plots, calibration slope, calibration-in-the-large), and net benefit. Performance measures were estimated separately in each available study and then, where possible, combined across studies in a random-effects meta-analysis. Results Of 131 published models, 67 provided the full model equation and 24 could be validated in 11 UK cohorts. Most of the models showed modest discrimination with summary C-statistics between 0.6 and 0.7. The calibration of the predicted compared to observed risk was generally poor for most models with observed calibration slopes less than 1, indicating that predictions were generally too extreme, although confidence intervals were wide. There was large between-study heterogeneity in each model’s calibration-in-the-large, suggesting poor calibration of the predicted overall risk across populations. In a subset of models, the net benefit of using the models to inform clinical decisions appeared small and limited to probability thresholds between 5 and 7%. Conclusions The evaluated models had modest predictive performance, with key limitations such as poor calibration (likely due to overfitting in the original development datasets), substantial heterogeneity, and small net benefit across settings. The evidence to support the use of these prediction models for pre-eclampsia in clinical decision-making is limited. Any models that we could not validate should be examined in terms of their predictive performance, net benefit, and heterogeneity across multiple UK settings before consideration for use in practice. Trial registration PROSPERO ID: CRD42015029349

Barriers and facilitators for sustainable weight loss in the pre-conception period among Danish women with overweight or obesity – a qualitative study

Abstract Background The prevalence of overweight or obesity in women of reproductive age continues to increase. A high pre-pregnancy body mass index (BMI) has been shown to increase the risk of pregnancy complications and predispose offspring to childhood obesity. However, little is known about factors affecting women’s ability to achieve sustainable weight management and very few studies have applied behavior change theory to qualitative data. Aim This study aimed to explore barriers and facilitators for weight management among women with overweight or obesity, who wanted to lose weight before pregnancy. Methods We conducted semi-structured interviews with 17 women with a BMI ≥ 27 kg/m2, who planned to become pregnant in the near future. Data were analyzed using an abductive approach and the Capability, Opportunity, Motivation, and Behavior model was applied as a conceptual framework. Results The women’s strongest motivator for pre-conception weight loss was their ability to become pregnant. Barriers to successful weight management included their partners’ unhealthy behaviors, mental health challenges, competing priorities, and internalized weight stigmatization. The women described careful planning, partners’ health behaviors, social support, and good mental health as facilitators for sustainable weight management. Conclusion Our study provides insights into factors affecting weight management among women with overweight or obesity in the pre-conception period. Future interventions on weight management require a holistic approach, including a focus on social support, especially from the partner, and mental health, as well as an effort to limit internalized weight stigma

An umbrella review of systematic reviews on interventions of physical activity before pregnancy, during pregnancy, and postpartum to control and/or reduce weight gain

Background: The increasing prevalence of overweight and obesity worldwide represents a (chronic) complex public health problem. This is also seen among women of childbearing age despite increased efforts to promote physical activity (PA) interventions. Excessive gestational weight gain (GWG) is associated with negative health outcomes for both mothers and offspring. Objectives: To summarize current systematic reviews (SRs) on PA interventions during pregnancy and postpartum to prevent excessive GWG and identify the most effective approaches. Search Strategy: A literature search was conducted on major electronic databases (MEDLINE/Pubmed, Cochrane, Web of Science, Epistemonikos) from inception to March 2023. Selection Criteria: This study included SRs and meta-analyses of studies involving women aged 18 years or older from diverse ethnic backgrounds, who were either in the preconception period, pregnant, or within 1 year postpartum and who had no contraindications for exercise. Women with chronic diseases, such as pre-existing diabetes (type 1 or type 2) were excluded. Data Collection and Analysis: Two reviewers extracted data from selected studies assessing the impact of PA in preconception, pregnancy, and postpartum. Methodologic quality was assessed with the AMSTAR-2 tool. A narrative summary of results addresses relationships between PA and weight before, during, and after pregnancy, informing future research priorities for preventing excessive weight gain. This study is registered on PROSPERO (CRD420233946666). Main Results: Out of 892 identified articles, 25 studies were included after removing duplicates, unrelated titles, and screening titles and abstracts for eligibility. The results demonstrate that PA can help prevent excessive GWG and postpartum weight retention. Structured and supervised moderate-intensity exercise, at least twice a week, and each session lasting a minimum of 35 min seems to provide the greatest benefits. Conclusions: Women who comply with the PA program and recommendations are more likely to achieve adequate GWG and return to their pre-pregnancy body mass index after delivery. Further research is warranted to explore how preconception PA influences pregnancy and postpartum outcomes given the absence of identified preconception-focused interventions.Universidad de Granada / CBUA

Effectiveness of fetal scalp stimulation test in assessing fetal wellbeing during labor, a retrospective cohort study

BACKGROUND: It is discussed whether fetal scalp stimulation (FSS) test is a reliable complimentary tool to cardiotocography (CTG) to assess fetal wellbeing during labor. The test is based on the assumption that a well-oxygenated fetus, in contrast to the depressed fetus, will respond to a certain stimulus. The aim of this study was to investigate the effectiveness of the FSS-test.METHODS: A retrospective observational study carried out Copenhagen University Hospital, Herlev, Denmark. Laboring women with singleton pregnancies in cephalic presentation after gestation week 33 and indication for fetal blood sampling (FBS) were eligible for inclusion. The FSS-test was classified as positive when an acceleration was absent at the time of FBS and negative when an acceleration was present. Lactate in scalp blood was measured by the point-of-care device LactatePro™ and pH in artery umbilical cord blood by the stationary blood gas analyzer ABL800. Lactate level 7.1 were cut-offs for normality.RESULTS: Three hundred eighty-five women were included. The cohort was divided by the FBS-to-delivery time: Group 1 (n = 128) ≤ 20 min, Group 2 (n = 117) 21-59 min and Group 3 (n = 140) ≥ 60 min. The proportion of FSS-positive tests differed significantly between the groups (p < 0.000). In Group 1 the sensitivity, specificity and likelihoods for scalp lactate ≥4.2 mmol/L were 81.5 (95% CI 67-90.1), 13.3 18.5 (95% CI 5.9-24.6), LHR+ 0.94 (95% CI 0.8-1.1) and LHR - 1.4 (95% CI 0.6-3.2) and for umbilical artery pH ≤ 7.10 the values were 82.6% (95% CI 61.2-95.1), 16% (95% CI 9.4-24.7), 1.0 (95% CI 0.8-1.2) and 1.1 (95% CI 0.4-3) respectively. Regardless of the FBS-to-delivery time the LHR+ for lactate ≥4.2 mmol/L increased to 1.38 (95% CI 1.2-1.6).CONCLUSION: The effectiveness of scalp stimulation test was poor for both ruling in and out fetal hypoxia during labor. Absence of a provoked acceleration seems to be a normal phenomenon in the second stage of labor

Systematically developing a family-based health promotion intervention for women with prior gestational diabetes based on evidence, theory and co-production:the Face-it study

Abstract Background Women with prior gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes; however, this risk can be reduced by engaging in positive health behaviours e.g. healthy diet and regular physical activity. As such behaviours are difficult to obtain and maintain there is a need to develop sustainable behavioural interventions following GDM. We aimed to report the process of systematically developing a health promotion intervention to increase quality of life and reduce diabetes risk among women with prior GDM and their families. We distil general lessons about developing complex interventions through co-production and discuss our extensions to intervention development frameworks. Methods The development process draws on the Medical Research Council UK Development of complex interventions in primary care framework and an adaptation of a three-stage framework proposed by Hawkins et al. From May 2017 to May 2019, we iteratively developed the Face-it intervention in four stages: 1) Evidence review, qualitative research and stakeholder consultations; 2) Co-production of the intervention content; 3) Prototyping, feasibility- and pilot-testing and 4) Core outcome development. In all stages, we involved stakeholders from three study sites. Results During stage 1, we identified the target areas for health promotion in families where the mother had prior GDM, including applying a broad understanding of health and a multilevel and multi-determinant approach. We pinpointed municipal health visitors as deliverers and the potential of using digital technology. In stage 2, we tested intervention content and delivery methods. A health pedagogic dialogue tool and a digital health app were co-adapted as the main intervention components. In stage 3, the intervention content and delivery were further adapted in the local context of the three study sites. Suggestions for intervention manuals were refined to optimise flexibility, delivery, sequencing of activities and from this, specific training manuals were developed. Finally, at stage 4, all stakeholders were involved in developing realistic and relevant evaluation outcomes. Conclusions This comprehensive description of the development of the Face-it intervention provides an example of how to co-produce and prototype a complex intervention balancing evidence and local conditions. The thorough, four-stage development is expected to create ownership and feasibility among intervention participants, deliverers and local stakeholders. Trial registration ClinicalTrials.gov NCT03997773 , registered retrospectively on 25 June 2019