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Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study: protocol for a multisite, prospective, open cohort study of pregnancy and postpartum health outcomes in South Asia and sub-Saharan Africa

Introduction

Maternal and child mortality has markedly decreased worldwide over the past few decades. Despite this success, the decline remains unequal across countries and is overall insufficient to meet the Sustainable Development Goals. South Asia and sub-Saharan Africa bear most of the burden of maternal and child morbidity and mortality. Major gaps persist in our understanding of the causes, timing, diagnostic thresholds and risk factors for adverse outcomes in these regions. Addressing these gaps requires new ways to prevent and treat disease, from novel diagnostics to precision public health strategies, all of which rely on high-quality clinical data from diverse populations. The Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study aims to estimate population-level prevalence of morbidities and mortality and to assess biological, clinical and sociodemographic risk among mother–infant pairs in India, Pakistan, Kenya, Ghana and Zambia.

Methods and analysis

This study is a prospective, open cohort study with a planned recruitment of about 6000 women annually across six research sites in five countries. Participants are pregnant women enrolled less than 20 weeks gestation, as determined by ultrasound, identified through active house-to-house and facility-based surveillance. Robust clinical data will be collected at 12 scheduled study visits during antenatal care, labour and delivery, and through 1 year postpartum. A total of 34 outcomes will be captured. The primary analysis will estimate the burden of adverse outcomes and examine associated risk factors to inform future intervention strategies. Data will also be used to develop normative values for pregnant and postpartum women, as well as predictive models to assess pregnancy risk.

Ethics and dissemination

PRISMA received institutional and national ethical approvals. Findings will be published in peer-reviewed open-access journals and disseminated at national and international forums to inform clinical guidelines and public health practice.

Trial registration number

NCT05904145.

Translation and content validity of the Arabic Communication and Symbolic Behaviour Scales Developmental Profile (CSBS DP) Infant-Toddler Checklist

Por: Al-Bluwi · G. S. M. · Masuadi · E. · Marquis · A. · Al-Rifai · R. H. · Elbarazi · I. · Ahmed · L. A.
Objective

The Communication and Symbolic Behaviour Scales Developmental Profile Infant–Toddler Checklist (CSBS DP ITC) is a screening tool designed to identify early deficits in social communication, expressive speech/language and symbolic functioning in children aged 6–24 months. This study aimed to translate and content validate the CSBS DP ITC into Modern Standard Arabic.

Design

Methodological study involving translation and content validation.

Setting

The study was conducted in the United Arab Emirates.

Participants

The translation process involved five bilingual translators and one monolingual Arabic language expert. Ten experts participated in the content validation phase, and 10 parents of young children participated in the face validity assessment.

Outcome measures

Content Validity Indices (CVIs), including the Item-level CVI (I-CVI), the Scale-level CVI by Average (S-CVI/Ave) and the S-CVI by Universal Agreement (S-CVI/UA), along with modified kappa statistics, were calculated to assess item-level and scale-level clarity, relevance and comprehensiveness.

Results

Expert panel ratings showed high clarity (I-CVI: 0.8–1, S-CVI/Ave: 0.98, S-CVI/UA: 0.88) and similar relevance scores. Face validity assessments yielded clarity I-CVI scores of 0.9–1, with S-CVI/Ave at 0.98 and S-CVI/UA at 0.8. The modified kappa statistic ranged from 0.89 to 1, indicating strong agreement among parents.

Conclusions

The CSBS DP ITC was effectively translated and content validated into Modern Standard Arabic. The calculated CVI values ranged from excellent to acceptable. This step establishes a foundation before proceeding to full psychometric testing of the instrument, paving the way for a reliable and culturally appropriate tool to identify early communication delays for use across the Arab-speaking population.

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