Pastakia Sonak D, Njuguna Benson, Onyango Beryl Ajwang', Washington Sierra, Christoffersen-Deb Astrid, Kosgei Wycliffe K, Saravanan Ponnusamy
Department of Pharmacy Practice, Purdue Kenya Partnership, PO Box 5760, Eldoret, 30100, Kenya.
Department of Pharmacy, Moi Teaching and Referral Hospital, PO Box 3, Eldoret, 30100, Kenya.
BMC Pregnancy Childbirth. 2017 Jul 14;17(1):226. doi: 10.1186/s12884-017-1415-4.
Early diagnosis of gestational diabetes mellitus (GDM) is crucial to prevent short term delivery risks and long term effects such as cardiovascular and metabolic diseases in the mother and infant. Diagnosing GDM in Sub-Saharan Africa (SSA) however, remains sub-optimal due to associated logistical and cost barriers for resource-constrained populations. A cost-effective strategy to screen for GDM in such settings are therefore urgently required. We conducted this study to determine the prevalence of gestational diabetes mellitus (GDM) and assess utility of various GDM point of care (POC) screening strategies in a resource-constrained setting.
Eligible women aged ≥18 years, and between 24 and 32 weeks of a singleton pregnancy, prospectively underwent testing over two days. On day 1, a POC 1-h 50 g glucose challenge test (GCT) and a POC glycated hemoglobin (HbA1c) was assessed. On day 2, fasting blood glucose, 1-h and 2-h 75 g oral glucose tolerance test (OGTT) were determined using both venous and POC tests, along with a venous HbA1c. The International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria was used to diagnose GDM. GDM prevalence was reported with 95% confidence interval (CI). Specificity, sensitivity, positive predictive value, and negative predictive value of the various POC testing strategies were determined using IADPSG testing as the standard reference.
Six hundred-sixteen eligible women completed testing procedures. GDM was diagnosed in 18 women, a prevalence of 2.9% (95% CI, 1.57% - 4.23%). Compared to IADPSG testing, POC IADPSG had a sensitivity and specificity of 55.6% and 90.6% respectively while that of POC 1-h 50 g GCT (using a diagnostic cut-off of ≥7.2 mmol/L [129.6 mg/dL]) was 55.6% and 63.9%. All other POC tests assessed showed poor sensitivity.
POC screening strategies though feasible, showed poor sensitivity for GDM detection in our resource-constrained population of low GDM prevalence. Studies to identify sensitive and specific POC GDM screening strategies using adverse pregnancy outcomes as end points are required.
Clinical trials.gov : NCT02978807 , Registered 29 November 2016.
妊娠糖尿病（GDM）的早期诊断对于预防短期分娩风险以及母婴心血管和代谢疾病等长期影响至关重要。然而，由于资源有限人群存在相关后勤和成本障碍，撒哈拉以南非洲（SSA）地区的GDM诊断仍未达到最佳状态。因此，迫切需要一种在这种情况下筛查GDM的具有成本效益的策略。我们开展这项研究以确定妊娠糖尿病（GDM）的患病率，并评估在资源有限的环境中各种GDM即时检验（POC）筛查策略的效用。
年龄≥18岁、单胎妊娠24至32周的符合条件的女性前瞻性地接受了为期两天的检测。第1天，评估即时检验1小时50克葡萄糖耐量试验（GCT）和即时检验糖化血红蛋白（HbA1c）。第2天，使用静脉血检测和即时检验测定空腹血糖、75克口服葡萄糖耐量试验（OGTT）的1小时和2小时血糖水平，以及静脉血HbA1c。采用国际妊娠糖尿病研究组（IADPSG）标准诊断GDM。报告GDM患病率及95%置信区间（CI）。以IADPSG检测作为标准参考，确定各种POC检测策略的特异性、敏感性、阳性预测值和阴性预测值。
616名符合条件的女性完成了检测程序。18名女性被诊断为GDM，患病率为2.9%（95%CI，1.57% - 4.23%）。与IADPSG检测相比，即时检验IADPSG的敏感性和特异性分别为55.6%和90.6%，而即时检验1小时50克GCT（诊断切点≥7.2毫摩尔/升[129.6毫克/分升]）的敏感性和特异性分别为55.6%和63.9%。评估的所有其他POC检测敏感性均较差。
即时检验筛查策略虽然可行，但在我们GDM患病率较低的资源有限人群中，对GDM检测的敏感性较差。需要开展以不良妊娠结局为终点来确定敏感且特异的POC GDM筛查策略的研究。
ClinicalTrials.gov：NCT02978807，2016年11月29日注册。
