OBJECTIVE:To synthesize evidence on the effectiveness of different instruments for assisted vaginal birth and to assess the prevalence of maternal and neonatal adverse outcomes associated with assisted vaginal birth and second-stage cesarean section. DATA SOURCES:A comprehensive search was conducted in Cochrane, Embase, and MEDLINE to identify randomized controlled trials and cross-sectional and cohort studies published between January 2001 and December 2023. STUDY ELIGIBILITY CRITERIA:Studies published in English, Spanish, French, or Italian with >30 participants, conducted in any type of healthcare facility, and reporting operative procedures in the second stage of labor were eligible if they included at least one outcome of interest for women undergoing assisted vaginal birth and/or second-stage cesarean section. STUDY APPRAISAL AND SYNTHESIS METHODS:Two independent reviewers conducted study selection, data extraction, and quality assessment. Meta-analyses of proportions were performed using random-effects models, and heterogeneity was assessed using the I2 statistic. RESULTS:A total of 241 studies, involving 751,242 participants, were included, of which 231 were observational and 10 randomized controlled trials. Prevalence estimates for assisted vaginal birth failure and adverse outcomes varied widely. Vacuum extraction had a significantly higher failure rate than forceps (7.60% vs 3.26%, P<.01), but a lower prevalence of obstetric anal sphincter injury (4.73% vs 7.99%, P<.01). Spatula use was associated with a lower prevalence of neonatal cephalohematoma compared to vacuum extraction (0.73% vs 5.45%, P<.01) and forceps (0.73% vs 3.54%, P<.01), but a higher prevalence of postpartum hemorrhage compared to vacuum extraction (10.77% vs 5.46%, P<.0001). Compared to assisted vaginal birth, second-stage cesarean section was associated with significantly higher rates of neonatal intensive care unit admission (17.18% vs 6.64% forceps, 6.07% vacuum extraction, P<.001), low Apgar scores (6.01% vs 2.43% forceps, 2.05% vacuum extraction, P<.01), skull fractures (1.54% vs 0.27% for both, P<.05), and neonatal death (1.95% vs 0.31% for both, P<.01). CONCLUSION:Contemporary data reveal wide variability in the prevalence of failed assisted vaginal birth and adverse maternal and neonatal outcomes following operative delivery in the second stage of labor. While assisted vaginal birth carries specific risks, it may offer advantages over emergency second-stage cesarean section, particularly regarding neonatal outcomes.

Preterm birth (PTB), defined as the birth of a child before 37 completed weeks gestation, affects approximately 11% of live births and is the leading cause of death in children under 5 years. PTB is a complex disease with multiple risk factors including genetic variation. Much research has aimed to establish the biological mechanisms underlying PTB often through identification of genetic markers for PTB risk. The objective of this review is to present a comprehensive and updated summary of the published data relating to the field of PTB genetics. A literature search in PubMed was conducted and English studies related to PTB genetics were included. Genetic studies have identified genes within inflammatory, immunological, tissue remodeling, endocrine, metabolic, and vascular pathways that may be involved in PTB. However, a substantial proportion of published data have been largely inconclusive and multiple studies had limited power to detect associations. On the contrary, a few large hypothesis-free approaches have identified and replicated multiple novel variants associated with PTB in different cohorts. Overall, attempts to predict PTB using single “-omics” datasets including genomic, transcriptomic, and epigenomic biomarkers have been mostly unsuccessful and have failed to translate to the clinical setting. Integration of data from multiple “-omics” datasets has yielded the most promising results.

The timing of parturition is crucial for neonatal survival and infant health. Yet, its genetic basis remains largely unresolved. We present a maternal genome-wide meta-analysis of gestational duration ( n = 195,555), identifying 22 associated loci (24 independent variants) and an enrichment in genes differentially expressed during labor. A meta-analysis of preterm delivery (18,797 cases, 260,246 controls) revealed seven associated loci and large genetic similarities with gestational duration. Analysis of the parental transmitted and nontransmitted alleles ( n = 136,833) shows that 15 of the gestational duration genetic variants act through the maternal genome, whereas 7 act both through the maternal and fetal genomes and 2 act only via the fetal genome. Finally, the maternal effects on gestational duration show signs of antagonistic pleiotropy with the fetal effects on birth weight: maternal alleles that increase gestational duration have negative fetal effects on birth weight. The present study provides insights into the genetic effects on the timing of parturition and the complex maternal–fetal relationship between gestational duration and birth weight.

Concerning emergency cesarean delivery vs operative vaginal delivery with forceps or vacuum, the current scientific debate on the maximum length of the second stage is inherently conditioned by the safety concerns associated with the intervention options to hasten birth.1Nelson D.B. McIntire D.D. Leveno K.J. Second-stage labor: consensus versus science.Am J Obstet Gynecol. 2020; 222: 144-149Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar The use of forceps and vacuum leads to successful fetal extraction in most cases2Verma G.L. Spalding J.J. Wilkinson M.D. Hofmeyr G.J. Vannevel V. O'Mahony F. Instruments for assisted vaginal birth.Cochrane Database Syst Rev. 2021; 9: CD005455PubMed Google Scholar and is recommended by the leading scientific societies in women with prolonged second stage of labor and engaged fetal head to safely avoid primary cesarean delivery.3Caughey A.B. Cahill A.G. Guise J.M. Rouse D.J. American College of Obstetricians and Gynecologists (College), Society for Maternal-Fetal MedicineSafe prevention of the primary cesarean delivery.Am J Obstet Gynecol. 2014; 210: 179-193Abstract Full Text Full Text PDF PubMed Scopus (195) Google Scholar However, a small risk of severe fetal trauma is associated with operative vaginal delivery, especially in cases of fetal malposition, when placement of the forceps and vacuum on the fetal head is more likely to be suboptimal.4Palatnik A. Grobman W.A. Hellendag M.G. Janetos T.M. Gossett D.R. Miller E.S. Predictors of failed operative vaginal delivery in a contemporary obstetric cohort.Obstet Gynecol. 2016; 127: 501-506Crossref PubMed Scopus (24) Google Scholar Under these circumstances, the risk of a failed extraction, which requires an emergency cesarean delivery, is increased.4Palatnik A. Grobman W.A. Hellendag M.G. Janetos T.M. Gossett D.R. Miller E.S. Predictors of failed operative vaginal delivery in a contemporary obstetric cohort.Obstet Gynecol. 2016; 127: 501-506Crossref PubMed Scopus (24) Google Scholar The Odon Device, an investigational instrument for operative vaginal delivery, aims to bring a new perspective to this debate as current evidence is suggestive of a very positive fetal safety profile, relative ease of use, limited training requirements, and high maternal acceptability.5Hotton E.J. Lenguerrand E. Alvarez M. et al.Outcomes of the novel Odon device in indicated operative vaginal birth.Am J Obstet Gynecol. 2021; 224: 607.e1-607.e17Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar Efficacy rates in premarket clinical trials increased from 48% in an early feasibility study5Hotton E.J. Lenguerrand E. Alvarez M. et al.Outcomes of the novel Odon device in indicated operative vaginal birth.Am J Obstet Gynecol. 2021; 224: 607.e1-607.e17Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar to 66.3% and 88.5% in 2 recently completed efficacy and safety studies (ASSIST [Assisted Vaginal Birth] II[Hotton EJ, Crofts JF, Draycott TJ, personal communication, May 2022] and ASSIST Besançon Study: Riethmuller D, Congrès Infogyn, 8 octobre 2021, Pau, France). These results may increase obstetricians' confidence in performing operative vaginal delivery, thereby expanding the scope of this intervention in the management of the second stage of labor. The Odon Device consists of a circular inflatable air cuff attached to a thin circumferential polyethylene sleeve. A semirigid plastic applicator made of a handle and 4 flexible plastic spatulas is used to place the air cuff and sleeve in the birth canal beyond the widest diameter of the fetal head. The air sleeve is inflated around the fetal head, and the applicator is removed. Using the inflated air chamber as a soft anchor point on the fetal head, the birth attendant applies traction to the polyethylene sleeve to facilitate the birth of the newborn. Because of this mechanism of action, the Odon Device does not cause typical bruising patterns on the fetal head, as is the case with forceps and vacuum. This feature prevents the identification of where on the fetal head the Odon Device anchors during the postnatal examination of the newborn. Preclinical studies on birth simulators indicated that the Odon air cuff is expected to seat around the chin and occiput of the fetus when inflated,6O'Brien S.M. Winter C. Burden C.A. Boulvain M. Draycott T.J. Crofts J.F. Fetal head position and perineal distension associated with the use of the BD Odon Device™ in operative vaginal birth: a simulation study.BJOG. 2017; 124: 10-18Crossref PubMed Scopus (12) Google Scholar but this has not been demonstrated in pregnant women. Intrapartum transperineal ultrasonography can be used to confirm the station and position of the fetal head before performing instrumental vaginal delivery and has been reported to be valuable in predicting the success of vacuum- or forceps-assisted birth.7Kahrs B.H. Usman S. Ghi T. et al.Sonographic prediction of outcome of vacuum deliveries: a multicenter, prospective cohort study.Am J Obstet Gynecol. 2017; 217: 69.e1-69.e10Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar Therefore, we applied this technique to determine the level of the anchor point of the Odon Device on the head of the fetus in 2 pregnant women in labor who had an indication for operative vaginal delivery in the context of an efficacy and safety clinical trial of the device conducted in Besançon, France (ASSIST Besançon Study approved by the institutional review board, Besançon, France, August 9, 2019). The women consented to participate in the trial, including the filming of the procedures and the ultrasound visualizations. The Figure, A, shows the Odon Device fully inserted into the birth canal with the air chamber positioned around the fetal head. Moreover, the Figure, B and C, shows transperineal ultrasound visualizations of the device placement in the occiput anterior (OA) and occiput posterior (OP) fetal positions, respectively, with key anatomic references. The Video shows an animated application of the Odon Device, the process of device insertion, and its visualization at transperineal ultrasonography in 2 different fetuses in either the OA or the OP position. In the ultrasound visualization of the device insertion in the OA position, an echogenic spatula of the device inserter is seen to slide between the pubis and the fetal parietal bone until its tip reaches the occipital bone (Video). In the OP position, the spatula is seen to slide over the parietal bone, finally resting on the chin (Video). The inflatable air chamber used as an anchor point to apply traction is not visible by ultrasonography but is positioned at the distal end of the echogenic spatula. These findings were consistent with the observations made in birth simulators5Hotton E.J. Lenguerrand E. Alvarez M. et al.Outcomes of the novel Odon device in indicated operative vaginal birth.Am J Obstet Gynecol. 2021; 224: 607.e1-607.e17Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar and provided additional evidence on the mechanism of action of the Odon Device. The authors thank Drs. Hotton and Crofts and Professor Draycott for providing information on the ASSIST II study. eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiJmZDQ3OTUxYzJhNzE5ZWUzNjQ3NDUxNTcyYjI5NGNmMSIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNzExMzg0OTM0fQ.iKF3lEwvKourBh34AradFzlR0PMvV_YUAsuMIuhvSdEJtRA17dpG3CQNh2L355lwnRygQH1SEdm97xTVUMSTLGaVMMBOVfGCR-btVSREukiGWH6h3MqqaNIqHVvK9iH3DL1ct83hqdZ4FpMhIAOZGQ8wX5T7nCqSOdu423SXFyPZqOyaa8h2S8rpf2B-6xplBOdskIN6dULYkO4F5MU0i9fzx6c4VBXiqXkGPhyUDQdTbWWuLwFzSrzZ2UpNpRK1X99OhhU6KERpVjeFgoCXSId_BPIOf15FU6IlqQyy-YD_f3TuzseYDeL3rLWb0m3ZeqNbTm7zkhL3cZVl4b-NtA Download .mp4 (24.51 MB) Help with .mp4 files VideoOdon device applicationMottet. Odon device visualization during operative vaginal delivery. Am J Obstet Gynecol 2022.

Since the onset of the SARS-CoV-2 pandemic, concerns have been raised about its potential indirect negative effects on maternal and perinatal health due to the disruption of and limitations on access to health services [1]. The likely increase in maternal deaths in lowand middle-income countries (LMICs) during the pandemic is of particular concern given that women in these countries are already disproportionately burdened by complications of pregnancy and childbirth. However, only a few LMICs have published data on maternal mortality levels during the pandemic [2]. A recently published systematic review of the indirect effects of COVID 19 on pregnancy outcomes identified only four studies reporting levels of maternal mortality during the pandemic in LMICs [3]. This lack of data hinders assessment of the toll of the pandemic on maternal health and the ability of LMICs to generate appropriate response measures. To contribute to global efforts to determine the effects of COVID 19 on pregnancy outcomes, we estimated excess maternal deaths during the period of the first wave of the SARS-CoV-2 pandemic in Chile (March-December 2020). Data on maternal mortality from 1990 to 2020 were obtained from the Chilean Ministry of Health, Department of Information (DEIS) [4], upon request for research purposes under the Transparency Law (L 20.285). Maternal deaths from Covid-19 were all confirmed by the PCR test for Sars-Cov-2, and coded according to ICD10 [5]. A negative binomial model was applied to estimate excess maternal deaths by comparing the number of deaths recorded from March to December 2020 to the estimated expected levels based on the number of maternal deaths recorded during the same months in previous 30 years [6]. In 2020, maternal mortality in Chile rose to 28.1 deaths per 100,000 live births from the 19.2 level recorded in 2019, reversing the declining trend observed over the previous thirty years.

The OdonAssistTM inflatable device for assisted vaginal birth is an investigational device which underwent premarket clinical testing. The clinical evidence generation plan includes preclinical and clinical studies to support development, regulatory approval and post market surveillance of the device.

Resumen: Introducción: En Chile los casos reportados de COVID-19 a nivel nacional al tercer año de pandemia (3 de noviembre del 2022) son de 4.769.638 y 61.725 fallecidos (1,3%), con el 93% de la población con esquema completo de vacunación (17.686.528). Objetivo: El objetivo de este estudio es una comunicación breve sobre el impacto de la pandemia de SARS-CoV-2 en la mortalidad materna, perinatal y prematuridad en Chile. Método: Se utilizó la base de datos nacional del Departamento de Informática del Ministerio de Salud de Chile (DEIS), y la información reportada desde sitio web oficial de OMS. Se incluyeron todos los nacidos, muertes generales y fetales desde enero 1990 a septiembre del 2022. Se realiza una comparación entre los indicadores básicos maternos y perinatales de los últimos 30 años y los de los años de la pandemia. Resultados: Desde marzo 2020 a septiembre 2022, fallecieron más de 61.000 personas en Chile con diagnóstico asociado al COVID-19, el 17% de la mortalidad general para el período (364.000 fallecidos). Se observó una aceleración en la tendencia histórica hacia la disminución de la razón nacimientos/defunciones generales de 1,9 pre-pandemia a 1,4 al tercer año de pandemia. La razón de mortalidad materna en el año 2020 fue de 28,1 × 100.000 nacidos vivos y aumentó en comparación al año 2019 pre-pandemia (19,1) o a la línea simple de tendencia histórica proyectada para el 2020 (18) en un 56%. La prematuridad bajo 37 semanas de gestación, se incrementó de 8,5% (2019) a 9,5% para los años 2021 y 2022. La mortalidad neonatal de los primeros 28 días se mantuvo estable en 9 × 1.000 nacidos vivos durante los 3 años de pandemia y la mortalidad fetal (>21 semanas) tuvo un leve incremento a 4,7 × 1.000 nacidos vivos (año 2020) en relación a 3,4 del año 2019. Conclusiones: En Chile ocurrió un aumento de aproximadamente un 56% de la mortalidad materna el primer año de pandemia de SARS-CoV-2, el segundo año se observa un aumento significativo de la prematuridad tardía y un leve incremento de la mortalidad fetal. Estos hallazgos han sido reportados en las revisiones y últimas actualizaciones del año 2022. Abstract: Introduction: At the third year of the pandemic in Chile, the reported cases of COVID-19 reached 4,769,638 and 61,725 deaths (1.4%), with 93% of the population with a complete vaccination schedule (17,686,528). Aim: The purpose of this study is a brief communication on the impact of the SARS-CoV-2 pandemic on maternal, perinatal and prematurity mortality in Chile. Method: The national database of the Informatics Department of the Ministry of Health of Chile (DEIS), and the information reported from the official WHO website were used. All births, general and fetal deaths from January 1990 to September 2022 were included. A comparison is made between the basic maternal and perinatal indicators of the last 30 years and those of the years of the pandemic. Results: From March 2020 to September 2022, approximately 61,000 people died in Chile with a diagnosis associated with COVID-19, 17% of the general mortality for the period (approx. 364.000 deaths). An acceleration in the historical trend towards a decrease in the overall birth/death ratio was observed from 1.9 pre-pandemic to 1.4 during the third year of the pandemic. Maternal Mortality Ratio in 2020 (28.1 × 100,000) increased compared to 2019 pre-pandemic (19.1) or the simple historical trend line projected for 2020 (18.0) by 56%. Prematurity under 37 weeks of gestation increased from 8.5% (2019) to 9.5% for the years 2021 and 2022. Neonatal mortality in the first 28 days remained stable at 9 per thousand births during the 3 years of the pandemic and fetal mortality (>21 weeks) had a slight increase to 4.7 per thousand (year 2020) in relation to 3.4 in 2019. Conclusions: In Chile, an increase of approximately 56% in maternal mortality occurred in the first year of the SARS-CoV-2 pandemic. In the second year, a significant increase in late prematurity and a slight increase in fetal mortality were observed. These findings have been reported in the reviews and latest updates of the year 2022.

El dispositivo inflable OdonAssist™ para parto vaginal asistido es un dispositivo de investigación que se sometió a pruebas clínicas previas a la comercialización. El plan de generación de evidencia clínica incluye estudios preclínicos y clínicos para respaldar el desarrollo, la aprobación regulatoria y la vigilancia posterior a la comercialización del dispositivo.

Introduction: At the third year of the pandemic in Chile, the reported cases of COVID-19 reached 4,769,638 and 61,725 deaths (1.4%), with 93% of the population with a complete vaccination schedule (17,686,528). Aim: The purpose of this study is a brief communication on the impact of the SARS-CoV-2 pandemic on maternal, perinatal and prematurity mortality in Chile. Method: The national database of the Informatics Department of the Ministry of Health of Chile (DEIS), and the information reported from the official WHO website were used. All births, general and fetal deaths from January 1990 to September 2022 were included. A comparison is made between the basic maternal and perinatal indicators of the last 30 years and those of the years of the pandemic. Results: From March 2020 to September 2022, approximately 61,000 people died in Chile with a diagnosis associated with COVID-19, 17% of the general mortality for the period (approx. 364.000 deaths). An acceleration in the historical trend towards a decrease in the overall birth/death ratio was observed from 1.9 pre-pandemic to 1.4 during the third year of the pandemic. Maternal Mortality Ratio in 2020 (28.1 x 100,000) increased compared to 2019 pre-pandemic (19.1) or the simple historical trend line projected for 2020 (18.0) by 56%. Prematurity under 37 weeks of gestation increased from 8.5% (2019) to 9.5% for the years 2021 and 2022. Neonatal mortality in the first 28 days remained stable at 9 per thousand births during the 3 years of the pandemic and fetal mortality (>21 weeks) had a slight increase to 4.7 per thousand (year 2020) in relation to 3.4 in 2019. Conclusions: In Chile, an increase of approximately 56% in maternal mortality occurred in the first year of the SARS-CoV-2 pandemic. In the second year, a significant increase in late prematurity and a slight increase in fetal mortality were observed. These findings have been reported in the reviews and latest updates of the year 2022.

OBJECTIVE AND METHODS:We conducted a prospective observational cohort study in 458 pregnant and puerperal women, with confirmed COVID-19 at Hospital San Jose, Santiago, Chile, to determine the impact of COVID-19 on pregnancy and confirm safety and feasibility of a management protocol based on clinical presentation of the disease. RESULTS:25.5% (117/458) of women were severe and 74.4% (341/458) mild presentation. Three percent (9/341) of mild presentations required a subsequent hospitalization. Overall, 26/458 women (5.6%) were admitted to ICU, and 13/458 (2.8%) required mechanical ventilation. One maternal death occurred at 49-days postpartum. Severe presentation, infection above 24 weeks, and comorbidities were associated with an adverse maternal outcome. Of total deliveries, 16.5% (36/217) were <37 weeks. Perinatal mortality was 6/226 (2.7%), mostly due to the fetal component. CONCLUSIONS:A quarter of the women had severe COVID-19 that, combined with occurrence of disease in the second half of pregnancy, resulted in substantial maternal compromise. Perinatal morbidity and mortality in women with severe disease were high and warrant consideration. Outpatient management was safe for mild cases.

The disruptive effects of pandemics on the delivery of health services is increasingly recognised as a global threat to maternal and child health.1 The COVID-19 pandemic has further highlighted the need to not only rapidly develop health-care innovations but to also make them equitably available.2 In this context, innovations that contribute to maintaining coverage of essential interventions, such as by facilitating task shifting, simplifying service delivery, or both, are crucial. Therefore, we argue that the case for a dedicated financing mechanism for scaling up innovations in women's, children's, and adolescents' health is stronger than ever.

Improving maternal and perinatal care is a global priority. Simulation training and novel applications of simulation for intrapartum care may help to reduce preventable deaths worldwide. Evaluation studies have published details of the effectiveness of simulation training for obstetric emergencies, exploring clinical and non-clinical factors as well as the impact on patient outcomes (both maternal and neonatal). This review summarized the many uses of simulation in obstetric emergencies from training to assessment. It also described the adaption of training in low-resource settings and the evidence behind the equipment recommended to support simulation training. The review also discussed novel applications for simulation such as its use in the development of a new device for assisted vaginal birth and its potential role in Cesarean section training. This study analyzed the financial implications of simulation training and how this may impact the delivery of such training packages, considering that simulation should be developed and utilized as a key tool in the development of safe intrapartum care in both emergency and non-emergency settings, in innovation and product development.

The increase of caesarean sections (CS) represents a global concern. Interventions tested to reduce unnecessary caesareans have shown limited success to date, partly because they have focused on medical perspectives or on single faceted interventions targeting only one group of stakeholders. Limited attention has been given to examining multidisciplinary and advocacy activities that could reduce unnecessary CS by raising awareness and engaging the media, advocacy groups, healthcare professionals and politicians. In 2009 in Italy, the national CS rate was the highest in Europe and momentum was building for action. This case study includes a description of the activities conducted in Italy during 2009–2012 by a partnership that included the non-governmental organisation Osservatorio Nazionale sulla Salute della Donna, a bipartisan group of Italian women parliamentarians and the WHO. The objectives were to generate awareness about the increase and overuse of CS in Italy, to foster political actions to reverse this trend, to engage with the media and journalists and to better understand women’s birth preferences and needs. A reduction of the CS rate has been observed in Italy following the activities of the initiative from 38.4% in 2009 to 34.2% in 2015 according to the Ministry of Health. Although we cannot infer a casual association between the Partnership and the CS decrease, it did contribute to political momentum and specific actions that should, in theory, have contributed to this reduction. These include the engagement of women parliamentarians for policy change, improved understanding of the local drivers of increases of CS including women’s needs and preferences, raising awareness and working with the media to convey appropriate information and an inclusive strategy giving the opportunity to local stakeholders to make their voices heard. This partnership initiative illustrates a model for generating dialogue, reflection and action in countries showing signs of readiness to address escalating CS.

BACKGROUND:High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. METHODS:We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. FINDINGS:Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81-1039·11; p<0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29 874 (97·1%) of 30 772 in the intervention period (1875·18; 1447·56-2429·11; p<0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70-2·09; p<0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites. INTERPRETATION:A supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies. FUNDING:Government of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

BACKGROUND:A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS:Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. RESULTS:Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. CONCLUSIONS:Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. TRIAL REGISTRATION:ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

Transition from design to adoption of innovations must be evidence-based and inform product development, regulatory approval and adoption

Objective To (1) determine how intended users interact with and use the BD Odon Device in simulation, (2) use these findings to alter progressively the design of the BD Odon Device and (3) validate that these changes have improved the ability of practitioners to use the BD Odon Device. Design Human factors evaluation study. Setting Simulation suite designed to mimic delivery room. Population or sample Three hundred and ninety simulated operative births, performed by 100 practising clinicians. Methods Simulated operative vaginal births performed using the BD Odon Device and the device Instructions for use were subjected to three formative human factors evaluations and one human factors validation test. Following each evaluation, findings were reviewed and the design of the BD Odon Device and Instructions for use were modified. Main outcome measures Successful performance of an operative vaginal birth using the BD Odon Device in accordance with provided training and Instructions for use . Results Using version two of the BD Odon Device, and following exposure to face‐to‐face training and written instructions, 25% of accouchers were able successfully to perform a simulated operative vaginal birth. In the final evaluation, following device design and training material alterations, all accouchers were able successfully to perform a simulated operative vaginal birth using version four of the BD Odon Device. Conclusions Human factors evaluations have enabled a multi‐professional device and training materials design team to alter the design of the BD Odon Device and the Instructions for use in an evidence‐based fashion. This process has resulted in a device which has a predictable and likely safe pattern of use. Tweetable abstract Human Factors evaluations help make the BD Odon Device safe and usable for clinical practice.

(Abstracted from BMC Pregnancy Childbirth 2016;16:198) Approximately 7.9 million children are born with birth defects, and 3.3 million children younger than 5 years die because of congenital anomalies annually. It is well known that congenital malformations contribute significantly to neonatal mortality.

Zinc is an essential micronutrient for the development of the fetal renal, cardiovascular and metabolic systems; however, there is limited evidence of its effects on the postnatal cardiometabolic function. In this study, we evaluated the effect of maternal zinc supplementation during pregnancy on the cardiometabolic profile of the offspring in childhood. A total of 242 pregnant women were randomly assigned to receive a daily supplement containing iron + folic acid with or without zinc. A follow-up study was conducted when children of participating mothers were 4.5 years of age to evaluate their cardiometabolic profile, including anthropometric measures of body size and composition, blood pressure, lipid profile and insulin resistance. No difference in measures of child cardiometabolic risk depending on whether mothers received supplemental zinc during pregnancy. Our results do not support the hypothesis that maternal zinc supplementation reduces the risk of offspring cardiometabolic disease.