More than 90% of gestational diabetes cases are estimated to occur in low-income and middle-income countries (LMICs). Most current guidelines recommend an oral glucose tolerance test (OGTT) at 24–28 weeks of gestation. The OGTT is burdensome, especially in LMICs, resulting in a high proportion of women not being screened. We aimed to develop a simple and effective screening strategy for gestational diabetes. STRiDE, a prospective cohort study, was set up in seven centres in south India and seven centres in western Kenya, and included pregnant women aged 18–50 years of age and at less than 16 weeks of gestation (<20 weeks in Kenya), confirmed by dating ultrasound. We assessed the efficacy of early pregnancy HbA (venous and capillary point-of-care), either alone or as part of a composite risk score with age, BMI, and family history of diabetes, in predicting gestational diabetes at 24–28 weeks of gestation, in two LMICs (India and Kenya) and in a UK multi-ethnic population from the PRiDE study. A key secondary outcome was to assess whether an early pregnancy composite risk score can reduce the need for OGTTs. Gestational diabetes was diagnosed using current WHO criteria. Between Feb 15, 2016, Dec 13, 2019, we enrolled 3070 participants in India and 4104 in Kenya. 4320 participants were included from the PRiDE cohort. Gestational diabetes prevalence by OGTT at 24–28 weeks was 19·2% in India, 3·0% in Kenya, and 14·5% in the UK. Early pregnancy HbA was independently associated with incidence of gestational diabetes at 24–28 weeks of gestation. Adjusted risk ratios were 1·60 (95% CI 1·19–2·16) in India, 3·49 (2·8–4·34) in Kenya, and 4·72 (3·82–5·82) in the UK. Composite risk score models that combined venous or point-of-care HbA with age, BMI, and family history of diabetes best predicted testing positive for gestational diabetes. A population-specific, two-threshold screening strategy of rule-in and rule-out gestational diabetes using early pregnancy composite risk score could reduce the requirement of OGTTs by 50–64%. For the HbA-alone model, the thresholds were 5·4% (rule in) and 4·9% (rule out) in India, 6·0% (rule in) and 5·2% (rule out) in Kenya, and 5·6% (rule in) and 5·2% (rule out) in the UK. Early pregnancy HbA offers a simple screening test for gestational diabetes, allowing those at highest risk to receive early intervention and greatly reduce the need for OGTTs. This can also be carried out using point-of-care HbA in LMICs. UK Medical Research Council and the Indian Department of Biotechnology.

中文翻译：

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早孕 HbA1c 作为妊娠糖尿病的首次筛查试验：来自三个前瞻性队列的结果


据估计，超过 90% 的妊娠糖尿病病例发生在低收入和中等收入国家 （LMIC）。目前的大多数指南建议在妊娠 24-28 周进行口服葡萄糖耐量试验 （OGTT）。OGTT 很繁重，尤其是在低收入和中等收入国家，导致很大比例的女性没有接受筛查。我们旨在开发一种简单有效的妊娠糖尿病筛查策略。STRiDE 是一项前瞻性队列研究，在印度南部的 7 个中心和肯尼亚西部的 7 个中心建立，包括 18-50 岁且妊娠 16 周以下（肯尼亚为 <20 周）的孕妇，通过测年超声证实。我们评估了早期妊娠 HbA （静脉和毛细血管即时护理） 的有效性，无论是单独使用还是作为与年龄、BMI 和糖尿病家族史的综合风险评分的一部分，在预测妊娠 24-28 周时妊娠糖尿病、两个低收入国家（印度和肯尼亚）和来自 PRiDE 研究的英国多种族人群。一个关键的次要结局是评估早期妊娠综合风险评分是否可以减少对 OGTTs 的需求。使用当前的 WHO 标准诊断妊娠糖尿病。在 2016 年 2 月 15 日至 2019 年 12 月 13 日期间，我们在印度招募了 3070 名参与者，在肯尼亚招募了 4104 名参与者。4320 名参与者来自 PRiDE 队列。OGTT 在 24-28 周的妊娠糖尿病患病率在印度为 19·2%，在肯尼亚为 3·0%，在英国为 14·5%。早孕 HbA 与妊娠 24-28 周的妊娠糖尿病发病率独立相关。印度调整后的风险比为 1·60 （95% CI 1·19–2·16），肯尼亚为 3·49 （2·8–4·34），英国为 4·72 （3·82–5·82）。 将静脉或床旁 HbA 与年龄、BMI 和糖尿病家族史相结合的综合风险评分模型最能预测妊娠糖尿病检测呈阳性。使用早期妊娠综合风险评分的针对人群的规则输入和排除妊娠糖尿病的双阈值筛查策略可以将 OGTT 的需求减少 50-64%。对于单独的 HbA 模型，印度的阈值为 5·4%（规则输入）和 4·9%（排除），肯尼亚为 6·0%（规则输入）和 5·2%（排除），英国为 5·6%（规则输入）和 5·2%（排除）。早孕 HbA 提供了一种简单的妊娠糖尿病筛查测试，使风险最高的人能够接受早期干预，并大大减少对 OGTT 的需求。这也可以在低收入和中收入国家使用即时 HbA 进行。英国医学研究委员会和印度生物技术部。