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Continuous non-invasive electrophysiological monitoring in high-risk pregnancies: study protocol of a cohort intervention random sampling study in a tertiary obstetrical care centre in the Netherlands (NIEM-O study)

Por: de Klerk · N. D. · Berben · P. B. Q. · de Vries · I. R. · Niemarkt · H. · Vullings · R. · van den Heuvel · E. R. · van der Ven · M. · Fransen · A. F. · Oei · S. G. · van Laar · J. O. E. H.
Introduction

Women with high-risk pregnancies (eg, pre-eclampsia, imminent preterm birth) are often hospitalised due to the need for foetal and maternal monitoring. They are monitored for 30–45 min up to three times a day with conventional cardiotocography (CTG). In the meantime, they reside at the hospital, but the foetal status is not monitored. Continuous foetal monitoring is currently not recommended using CTG, due to the potential temperature rise from consistent exposure to ultrasound waves. For safe 24/7 monitoring, newly developed devices using non-invasive electrophysiological cardiotocography (eCTG) instead of conventional CTG offer a promising alternative. Previous research into eCTG has shown favourable results in monitoring foetal heart rate throughout both pregnancy and labour. This study aims to investigate the effect of implementing continuous antepartum eCTG monitoring in hospitalised high-risk pregnancies on perinatal and maternal outcome.

Methods and analysis

In this single centre prospective cohort intervention random sampling study, eligible women will be included on the Obstetric High Care of Máxima MC Veldhoven, the Netherlands. In total, 511 pregnant women with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalisation will be recruited. Eligible women will be prospectively included in the cohort receiving standard treatment: intermittent CTG monitoring. From these women, a random sample of the prospective cohort will be offered a new monitoring method: 24/7 eCTG monitoring. For the eCTG monitoring, a wireless abdominal electrode patch, the Nemo Foetal Monitoring System will be used. Additional data from a historical cohort (2014–2019) of 1400 women receiving standard treatment will be included. Perinatal and maternal outcome, along with satisfaction levels of both patient and caregivers, will be compared between groups.

Ethics and dissemination

The study is registered on 18 October 2022 to the Central Committee on Research Involving Human Subjects (NL82869.015.22) via https://www.toetsingonline.nl/to/ccmo_monitor.nsf/conceptabr?OpenForm and approved by the Medical Ethics Committee of Máxima MC (W22.070) on 7 November 2023. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

Trial registration number

NCT06151613.

Incidence, risk factors and pregnancy outcomes of gestational diabetes mellitus in Ibadan, Southwest Nigeria: a prospective cohort study

Por: Adeoye · I. · Adedapo · K. S. · Sonuga · O. O. · Fagbamigbe · A. F. · Adeleye · J. O. · Olayemi · O. O. · Omigbodun · A. O. · Bamgboye · A. E.
Objective

Gestational diabetes mellitus (GDM) is an emerging public health concern in low and middle-income countries, including Nigeria, because of the associated pregnancy complications, increased healthcare costs and long-term health sequelae among women of reproductive age and their offspring. We determined the cumulative incidence, risk factors and pregnancy outcomes of GDM in Ibadan, Nigeria.

Design

Prospective cohort study.

Setting

Ibadan, Southwest Nigeria.

Participants

721 pregnant women from the Ibadan Pregnancy Cohort Study participated in the one-step 75 g-oral glucose tolerance test at 24–28 weeks’ gestation.

Outcomes

The primary outcome of the study is the cumulative incidence of GDM. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups criteria. Secondary outcomes were pregnancy outcomes, which included modes of delivery (CS, spontaneous vaginal delivery), macrosomia (birth weight ≥4.0 kg), gestational age at delivery and birth asphyxia. The risk factors (exposures) examined included sociodemographic, obstetric, clinical, behavioural and lifestyle factors. Bivariate and multivariate Log-binomial regression models were used to identify the independent risk factors of GDM (adjusted for maternal age ≥35 years, income, maternal body mass index, history of pregnancy loss and congenital anomaly) and the associated pregnancy outcomes of GDM (adjusted for maternal age, income and maternal body mass index). Adjusted relative risk (aRR) and 95% CI, used to assess the strength of associations, were reported.

Results

The cumulative incidence of GDM was 20.7%, 95% CI (17.9% to 23.9%). The mean time for the diagnosis of GDM is 25.4±1.42 weeks of gestation. After adjusting for other variables, maternal age ≥35 years: (aRR: 1.48). 95% CI (1.07 to 1.97) p=0.016), maternal obesity (aRR: 1.85, 95% CI (1.26 to 2.30) p=0.002) and a previous history of congenital anomaly (aRR: 2.83, 95% CI (1.97 to 4.07) p

Conclusion

The cumulative incidence of GDM is high among pregnant women in Ibadan. Maternal age ≥35 years, maternal obesity and a history of congenital anomaly were significant independent risk factors for GDM. These factors should be targeted for public health interventions, including lifestyle modification among pregnant women with obesity and early screening and diagnosis of GDM.

Association of non-standard working time arrangements with safety incidents: a systematic review

Por: Moen · L. V. · S Lie · J.-A. · Sterud · T. · Christensen · J. O. · Haugen · F. · Skogstad · M. · Nordby · K.-C. · Matre · D.
Objective

To systematically review the evidence on the association between non-standard working time arrangements (such as night work or shift work) and the occurrence of safety incidents.

Design

Systematic review conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and using a structured narrative approach and the Synthesis Without Meta-analysis framework to evaluate and summarise findings.

Data sources

MEDLINE, Embase, PsycINFO, Web of Science and ProQuest Health and Safety Science Abstracts were searched through February 2024.

Eligibility criteria for selecting studies

We included peer-reviewed English-language studies of paid workers (18–70 years) that examined the association between non-standard working time arrangements and safety incidents (accidents, near-accidents, safety incidents or injuries), excluding cross-sectional designs and studies on unpaid workers, athletes or military personnel.

Data extraction and synthesis

Two reviewers independently extracted data and assessed risk of bias using standardised forms, extracting study characteristics (author, year, country, sector and population), working time arrangements and exposure assessment, outcomes and their assessment, and reported risk estimates. We conducted a narrative synthesis, classifying studies into three exposure contrasts (shift worker versus non-shift worker, time-of-day and shift intensity), and summarised risk estimates using forest plots without calculating pooled effects.

Results

A total of 13 569 records were screened, and 24 studies met the inclusion criteria. The results indicated that shift workers generally had an elevated safety incident risk compared with non-shift workers (risk estimates ranged from 1.11 to 5.33). Most of the included studies found an increased risk of safety incidents during or after night shifts. Accumulated exposure to evening or night shifts increased the risk of safety incidents during the following 7 days. However, bias and heterogeneity across studies in design, populations and outcome measures resulted in an overall low to very low certainty of the evidence.

Conclusions

Non-standard working time arrangements, including night and evening shifts, appear to increase the risk of occupational safety incidents. Despite the low certainty of evidence, the findings highlight a potential area for preventive measures in work scheduling. Future longitudinal studies using individual data on daily working hours are needed.

Progression from uncomplicated to severe malaria among children in settings receiving different malaria control interventions in sub-Saharan Africa: a systematic review protocol

Por: Okek · E. J. · Lutwama · J. · Kinengyere · A. A. · Asio · J. · Awor · S. · Le Doare · K. · Musinguzi · B. · Sande · J. O. · Ocan · M. · Kayondo · J.
Background

Different malaria control measures are deployed simultaneously in endemic settings globally, with varying impacts on malaria burden. In sub-Saharan Africa, which bears the greatest burden of malaria, evidence on the impact of implementing various control interventions on malaria immunity remains unknown. This systematic review seeks to collate evidence on the extent of progression from uncomplicated to severe malaria among populations in sub-Saharan Africa settings receiving concurrent deployment of various malaria control measures.

Methods

The review will use a priori criteria contained in the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. An experienced librarian (AAK) will independently search for articles from the following databases: PubMed, Web of Science, Embase, Scopus and Google Scholar. Boolean operators ‘AND’ and ‘OR’ will be used in the article search. Identified articles will be managed using EndNote. Article screening for inclusion and data extraction will be done in duplicate by two reviewers (EJO, and BM). Data extraction tools will be developed and customised in Excel. Data will be analysed using both narrative and quantitative synthesis. The level of heterogeneity between study outcomes will be measured using the I2 statistic. Subgroup analysis will be conducted to explore heterogeneity and establish the impact of different control interventions on progression from uncomplicated to severe malaria. A full systematic review and meta-analysis is expected to be ready for dissemination by the end of December 2025.

Ethical consideration and dissemination of findings

This study did not involve human participants and so ethical approval was not sought. A full review and a meta-analysis will be published in a peer-reviewed journal and presented at national and international conferences.

PROSPERO registration number

CRD 42024619945.

Non-invasive electrophysiological monitoring vs conventional monitoring during labour in a tertiary obstetric care centre in the Netherlands: study protocol of a cohort intervention random sampling study (NIEM-II study)

Introduction

Conventional cardiotocography (CTG) has been used extensively to monitor the fetal condition during labour. However, conventional non-invasive monitoring is limited by the difficulty of obtaining an adequate signal quality, particularly in the case of obese parturients. Furthermore, the rate of operative deliveries keeps rising despite the ability for conventional intrapartum monitoring. Electrophysiological monitoring is an alternative technique that has been developed over the past decades to improve signal quality. This non-invasive, transabdominal and wireless alternative measures fetal heart rate by fetal electrocardiography (NI-fECG), and uterine activity by electrohysterography (EHG). Both NI-fECG and EHG have been proven to be more accurate and reliable than conventional non-invasive methods and are less affected by maternal Body Mass Index. Nevertheless, it is still unknown whether electrophysiological intrapartum monitoring leads to better obstetric and neonatal outcomes. This study aims to investigate whether electrophysiological monitoring during labour affects the number of operative interventions compared with conventional monitoring during labour.

Methods and analysis

This is a single-centre cohort intervention random sampling study which will be performed in a tertiary obstetric care centre. In total, 3471 term pregnant women with a singleton fetus in cephalic position and indication for continuous fetal monitoring during labour will be included. Eligible women will be prospectively included in the cohort for conventional monitoring. From these women, 90.9% of women will be randomly sampled and will be offered electrophysiological monitoring. A historical cohort of an additional 2100 women who received conventional monitoring will be added to the conventional group. This historical cohort was collected between April 2019 and February 2023. The primary outcome will be the number of operative interventions during labour. Secondary outcome measures include maternal and neonatal outcomes, patient and healthcare professional perspectives and costs.

Ethics and dissemination

This study received approval from the Medical Ethics Committee of Máxima Medical Centre (W22.071) on 1 November 2023. All participants will provide informed consent prior to data collection. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

Trial registration number

NCT06135961.

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