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孕期低钙血症和钙摄入量:在喀麦隆的三级医疗机构中对危险因素、母婴结局进行批判性分析,并评估诊断方法的研究方案。

Hypocalcaemia and calcium intake in pregnancy: A research protocol for critical analysis of risk factors, maternofoetal outcomes and evaluation of diagnostic methods in a third-category health facility, Cameroon.

机构信息

Kekem District Hospital, Kekem, West Region, Cameroon.

Department of Biochemistry, University of Dschang, Dschang, West Region, Cameroon.

出版信息

PLoS One. 2020 Nov 5;15(11):e0241812. doi: 10.1371/journal.pone.0241812. eCollection 2020.

Abstract

INTRODUCTION

Hypocalcaemia in pregnancy remains a major health issue, particularly in the developing world where daily calcium intakes are suboptimal. This electrolyte imbalance can lead to severe maternofoetal and childhood consequences. Calcium supplementation, amongst others, contributes significantly to meeting calcium demands in pregnancy. With ionised calcaemia as the gold standard for diagnosis, total calcaemia and albumin-corrected calcaemia in other pathological states have been found to overestimate the burden of hypocalcaemia. The main objectives of this study are to describe the blood calcium level (total, albumin corrected, and ionised calcaemia) and associated maternofoetal outcomes while identifying determinants of calcium supplementation and ionised hypocalcaemia. This study will also evaluate the sensitivity and specificity of albumin corrected calcaemia as a diagnostic tool for hypocalcaemia (ionised calcaemia as the gold standard) among pregnant women in the Nkongsamba Regional Hospital, Cameroon.

METHODS

Our study will target a total of 1067 term pregnant women who shall be included consecutively into the study as they arrive the maternity of the Nkongsamba Regional Hospital for their last antenatal care visit. Data shall be collected using a semi-structured interview-administered questionnaire and blood samples collected for total plasma calcium, albumin and serum ionized calcium assays. Additional data will be collected at birth (maternal and foetal variables; foetal outcomes evaluated as secondary outcomes). Total calcaemia and albuminemia shall be measured by atomic absorption spectrophotometry, while ionised calcaemia will be measured by ion-selective electrode potentiometry(using MSLEA15-H electrolyte analyzer) per standard BIOLABO and MSLEA15 protocols, respectively. Data will be analysed using the statistical softwares epi-Info version 7.2.2.16 and STATA version 16.

EXPECTED RESEARCH OUTCOME

This study will present a more precise estimate of the burden of hypocalcaemia in late pregnancy as well as identify and analyse the different factors associated with calcium supplementation and ionised hypocalcaemia among term pregnant women in a developing world setting. Maternofoetal outcomes associated with hypocalcaemia will be determined as well as the sensitivity and specificity of total and albumin-corrected calcaemia in diagnosing hypocalcaemia. Our findings will contribute significantly to designing or strengthening interventions to control this electrolyte imbalance.

摘要

简介

妊娠低钙血症仍然是一个主要的健康问题,特别是在发展中国家,那里的每日钙摄入量不足。这种电解质失衡会导致母婴和儿童严重后果。钙补充剂等方法对满足妊娠期间的钙需求有重要贡献。由于离子钙被认为是诊断的金标准,因此在其他病理状态下,总钙和白蛋白校正钙被发现高估了低钙血症的负担。本研究的主要目的是描述血钙水平(总钙、白蛋白校正钙和离子钙)以及相关的母婴结局,同时确定钙补充剂和离子低钙血症的决定因素。本研究还将评估白蛋白校正钙作为诊断工具的敏感性和特异性,以诊断孕妇的低钙血症(以离子钙为金标准),研究对象为喀麦隆 Nkongsamba 地区医院的 1067 名足月孕妇。

方法

我们的研究将针对总共 1067 名足月孕妇,这些孕妇将作为连续病例纳入研究,因为她们到达 Nkongsamba 地区医院进行最后一次产前检查。数据将通过半结构式访谈问卷收集,同时采集血样进行总血浆钙、白蛋白和血清离子钙检测。在分娩时还将收集额外数据(母婴变量;胎儿结局作为次要结局进行评估)。总钙和白蛋白将通过原子吸收分光光度法测量,而离子钙将通过离子选择性电极电位法(使用 MSLEA15-H 电解质分析仪)分别按照 BIOLABO 和 MSLEA15 标准协议进行测量。数据将使用统计软件 epi-Info 版本 7.2.2.16 和 STATA 版本 16 进行分析。

预期研究结果

本研究将更准确地估计妊娠晚期低钙血症的负担,并确定和分析发展中国家足月孕妇中与钙补充剂和离子低钙血症相关的不同因素。还将确定与低钙血症相关的母婴结局,以及总钙和白蛋白校正钙在诊断低钙血症方面的敏感性和特异性。我们的研究结果将为设计或加强干预措施以控制这种电解质失衡做出重大贡献。

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