Lek Sze Min, Ku Chee Wai, Allen John C, Malhotra Rahul, Tan Nguan Soon, Østbye Truls, Tan Thiam Chye
Duke-National University of Singapore Medical School, 8 College Road, Singapore, 169857, Singapore.
Department of Obstetrics and Gynecology, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore.
BMC Pregnancy Childbirth. 2017 Mar 6;17(1):78. doi: 10.1186/s12884-017-1261-4.
Our recent paper, based on a pilot cohort of 119 women, showed that serum progesterone <35 nmol/L was prognostic of spontaneous miscarriage by 16 weeks in women with threatened miscarriage in early pregnancy. Using a larger cohort of women from the same setting (validation cohort), we aim to assess the validity of serum progesterone <35 nmol/L with the outcome of spontaneous miscarriage by 16 weeks.
In a prospective cohort study, 360 pregnant women presenting with threatened miscarriage between gestation weeks 6-10 at a tertiary hospital emergency unit for women in Singapore were recruited for this study. The main outcome measure measured is spontaneous miscarriage prior to week 16 of gestation. Area under the ROC curve (AUC) and test characteristics (sensitivity, specificity, positive and negative predictive value) at a serum progesterone cutpoint of <35 nmol/L for predicting high and low risk of spontaneous miscarriage by 16 weeks were compared between the Pilot and Validation cohorts.
Test characteristics and AUC values using serum progesterone <35 nmol/L in the validation cohort were not significantly different from those in the Pilot cohort, demonstrating excellent accuracy and reproducibility of the proposed serum progesterone cut-off level.
The cut-off value for serum progesterone (35 nmol/L) demonstrated clinical relevance and allow clinicians to stratify patients into high and low risk groups for spontaneous miscarriage.
我们最近基于119名女性的试点队列研究表明，在孕早期有流产征兆的女性中，血清孕酮<35 nmol/L可预测16周时的自然流产情况。我们旨在利用来自同一研究背景下的更大规模女性队列（验证队列），评估血清孕酮<35 nmol/L对预测16周时自然流产结果的有效性。
在一项前瞻性队列研究中，招募了360名在新加坡一家三级医院急诊科就诊、孕6至10周出现流产征兆的孕妇。主要观察指标是妊娠16周前的自然流产情况。比较了试点队列和验证队列中，血清孕酮切点为<35 nmol/L时预测16周自然流产高风险和低风险的ROC曲线下面积（AUC）及检验特征（敏感性、特异性、阳性和阴性预测值）。
验证队列中使用血清孕酮<35 nmol/L时的检验特征和AUC值与试点队列无显著差异，表明所提议的血清孕酮临界值具有出色的准确性和可重复性。
血清孕酮临界值（35 nmol/L）具有临床相关性，可让临床医生将患者分为自然流产的高风险和低风险组。
