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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.

Effect of vitamin D supplementation during pregnancy and lactation on the development of infants born to Tanzanian women living with HIV: a secondary analysis of a randomised controlled trial

Por: Shobanke · T. · Muhihi · A. · Perumal · N. · Ulenga · N. · Al-Beity · F. M. A. · Duggan · C. P. · Fawzi · W. W. · Manji · K. P. · Sudfeld · C. R.
Background

Infants born to pregnant women living with HIV (WLHIV) are at greater risk for morbidity and mortality and may also have poorer developmental outcomes as compared with infants who are not exposed to HIV. Nutrition interventions in pregnancy may affect developmental outcomes.

Objectives

This study evaluated the effect of maternal vitamin D supplementation on infant development outcomes.

Design

We conducted a secondary analysis of a randomised, triple-blind, placebo-controlled trial of maternal vitamin D supplementation from June 2015 to October 2019.

Setting

Antenatal care clinics in Dar es Salaam, Tanzania.

Participants

Pregnant WLHIV and their offspring.

Interventions

Daily 3000 IU vitamin D3 or placebo supplements taken during pregnancy and lactation.

Outcome measures

Infants were assessed for cognitive, language and motor development at 1 year of age with the Caregiver Reported Early Development Instruments (CREDI).

Results

A total of 2167 infants were eligible, and 1312 of them completed CREDI assessments at 1 year of age. Vitamin D supplementation had no effect on overall CREDI z-scores (standardised mean difference (SMD) 0.03, 95% CI –0.09, 0.15, p value 0.66). There was also no evidence of a difference between vitamin D and placebo groups in language (SMD 0.06, 95% CI –0.08, 0.21, p value 0.40), motor (SMD 0.02, 95% CI –0.09, 0.14, p value 0.69) or cognitive domain z-scores (SMD 0.05, 95% CI –0.08, 0.17, p 0.48).

Conclusions

Maternal vitamin D supplementation during pregnancy and lactation did not affect infant development outcomes.

Trial registration number

ClinicalTrials.gov identifier: NCT02305927.

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