Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN).
Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN).
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DOI：
10.1136/bmjopen-2021-052554
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发表时间：
2022-07-26
期刊：
影响因子：
2.9
通讯作者：
Chew, Boon How
中科院分区：
文献类型：
--
作者：
Yap, Pamela Phui Har;Nadal, Iliatha Papachristou;Rysinova, Veronika;Basri, Nurul Iftida;Samsudin, Intan Nureslyna;Forbes, Angus;Noor, Nurain Mohd;Supian, Ziti Akthar;Hassan, Haslinda;Paimin, Fuziah;Zakaria, Rozita;Alias, Siti Rohani Mohamed;Bukhary, Norizzati Bukhary Ismail;Benton, Madeleine;Ismail, Khalida;Chew, Boon How
妊娠糖尿病（GDM）通常与不良妊娠结局相关。然而，与非GDM妇女相比，危险因素与GDM诊断、孕产妇和新生儿健康结局的关联性较低。我们的目的是检查传统和新的危险因素对GDM诊断的诊断准确性及其对孕产妇和新生儿健康结局的影响。这项回顾性队列和巢式病例对照研究在六个公共卫生诊所的基础上的医疗记录和问卷调查的妇女产后2至12个月。估计所需样本量为876份完整记录（292例病例，584例对照，比例为1：2）。口服葡萄糖耐量试验结果将用于确定葡萄糖调节异常，母体和新生儿结局包括母体体重增加、先兆子痫、羊水过多、分娩方式、早产或过期分娩、分娩并发症、出生体重、出生时胎龄、Apgar评分、先天性异常、先天性甲状腺功能减退症、新生儿死亡或死产、低血糖和高胆红素血症。心理社会测量包括世卫组织生活质量：简要、母婴结合（14项产后结合问卷和19项产妇产后依恋量表）、焦虑（7项广泛性焦虑症）、抑郁（9项患者健康问卷）和压力（感知压力量表症状）问卷。将报告孕产妇和新生儿健康结局的比较发生率、GDM和非GDM女性之间心理社会结局的比较患病率、风险因素的特异性、敏感性、阳性和阴性预测值（单独和合并）。将使用多变量回归分析对所有GDM风险因素和结局进行建模，并报告受试者工作特征曲线。本研究由马来西亚卫生部马来西亚研究和伦理委员会批准。将获得所有参与者的知情同意。研究结果将在科学期刊上发表。
Gestational diabetes mellitus (GDM) is often associated with adverse pregnancy outcomes. However, the association of risk factors with GDM diagnosis, maternal and neonatal health outcomes is less established when compared with women without GDM. We aim to examine the diagnostic accuracy of the conventional and novel risk factors for a GDM diagnosis and their impact on maternal and neonatal health outcomes. This retrospective cohort and nested case–control study at six public health clinics is based on medical records and questionnaire survey of women between 2 and 12 months postpartum. The estimated required sample size is 876 complete records (292 cases, 584 control, at a ratio of 1:2). Oral glucose tolerance test results will be used to identify glucose dysregulation, and maternal and neonatal outcomes include maternal weight gain, pre-eclampsia, polyhydramnios, mode of delivery, preterm or postdate birth, complications in labour, birth weight, gestational age at birth, Apgar score, congenital anomaly, congenital hypothyroidism, neonatal death or stillbirth, hypoglycaemia and hyperbilirubinaemia. Psychosocial measures include the WHO Quality of Life: brief, mother–infant bonding (14-item Postpartum Bonding Questionnaire and 19-item Maternal Postnatal Attachment Scale), anxiety (7-item Generalised Anxiety Disorder), depression (9-item Patient Health Questionnaire) and stress (Perceived Stress Scale symptoms) questionnaires. The comparative incidences of maternal and neonatal health outcomes, the comparative prevalence of the psychosocial outcomes between women with GDM and without GDM, specificity, sensitivity, positive and negative predictive values of the risk factors, separately and combined, will be reported. All GDM risk factors and outcomes will be modelled using multivariable regression analysis and the receiver operating characteristics curve will be reported. This study was approved by the Malaysia Research and Ethics Committee, Ministry of Health Malaysia. Informed consent will be obtained from all participants. Findings will be submitted for publications in scientific journals.
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DOI：
10.3390/ijerph13010068
发表时间：
2015-12-22
影响因子：
--
作者：
Bień A;Rzońca E;Kańczugowska A;Iwanowicz-Palus G
通讯作者：
Iwanowicz-Palus G
影响因子：
3.5
作者：
Dalfra, M. G.;Nicolucci, A.;Lapolla, A.
通讯作者：
Lapolla, A.
影响因子：
4.3
作者：
Nguyen CL;Pham NM;Binns CW;Duong DV;Lee AH
通讯作者：
Lee AH
影响因子：
158.5
作者：
DEVECIANA, M;MAJOR, CA;EVANS, AT
通讯作者：
EVANS, AT
影响因子：
8.2
作者：
Benhalima, Katrien;Mathieu, Chantal;Dunne, Fidelma
通讯作者：
Dunne, Fidelma