Department of Obstetrics and Gynaecology, Centre Hospitalier Departemental, La Roche sur Yon, France.
Department of Biology, Centre Hospitalier Departemental, La Roche sur Yon, France.
BMC Pregnancy Childbirth. 2018 Mar 7;18(1):65. doi: 10.1186/s12884-018-1696-2.
A hypothesis of preterm parturition is that the pathogenesis of spontaneous preterm birth (sPTB) may be associated with an inflammatory process. Based on this theory, we have hypothesized that an inflammatory biomarker, procalcitonin (PCT), may be a good predictive marker of sPTB at the admission for threatened preterm labour (TPL). The present study was aimed to investigate the association between serum PCT and sPTB in women with TPL and to evaluate whether PCT levels may predict sPTB in women with TPL within 7 or 14 days.
In a prospective observational laboratory-based study, women with singleton pregnancies, TPL between 24 and 36 weeks and intact membranes, were enrolled between January 2014 and June 2016. Participants received routine medical management of TPL (tocolysis with atosiban, antenatal corticosteroids, and biological tests at admission (C-reactive protein, white blood cell count, and PCT measured on electrochemiluminescence immunoassay)). The primary endpoint was sPTB before 37 weeks of gestation. The value of serum PCT levels to predict sPTB within 7 or 14 days were evaluated using receiver-operating curves (ROC) analysis.
A total of 124 women were included in our study. PCT levels did not statistically differ between women with sPTB (n = 30, 24.2%) and controls (n = 94) (median in ng/mL [interquartile range]: 0.043 [0.02-0.07] compared to 0.042 [0.02-0.13], respectively; P = 0.56). PCT levels did not also statistically differ between women with sPTB within 7 days (n = 7, 5.6%) or 14 days (n = 12, 9.7%) after testing and controls. Moreover, subgroup analysis revealed no difference among PCT levels at admission between 24 and 28 weeks, between 28 and 32 weeks and over 32 weeks, and controls. On the basis of the receiver-operating characteristic curve, the highest sensitivity and specificity corresponded to a PCT concentration of 0.038 ng/mL, with poor predictive values for sPTB within 7 or 14 days.
Serum PCT was not relevant to predict sPTB within 7 or 14 days in women admitted with TPL between 24 and 36 weeks, and thus it is not a suitable biological marker to confirm the hypothesis of an inflammatory process associated with preterm parturition.
Clinicaltrials.gov ( NCT01977079 ), Registered 24 October 2013.
早产分娩的一个假说认为自发性早产 (sPTB) 的发病机制可能与炎症过程有关。基于这一理论，我们假设炎症生物标志物降钙素原 (PCT) 可能是预测 TPL 入院时 sPTB 的良好预测指标。本研究旨在探讨 TPL 妇女血清 PCT 与 sPTB 之间的关系，并评估 PCT 水平是否可预测 TPL 妇女在 7 或 14 天内发生 sPTB。
在一项前瞻性观察性实验室基础研究中，纳入了 2014 年 1 月至 2016 年 6 月期间，24 至 36 周且胎膜完整的单胎妊娠、有 TPL 的妇女。参与者接受 TPL 的常规医疗管理（阿托西班催产、产前皮质激素和入院时的生物学检查（C 反应蛋白、白细胞计数和电化学发光免疫分析检测 PCT））。主要结局是在 37 周前发生 sPTB。使用受试者工作特征曲线 (ROC) 分析评估血清 PCT 水平预测 7 或 14 天内 sPTB 的价值。
共有 124 名妇女纳入本研究。sPTB 组（n=30，24.2%）和对照组（n=94）的 PCT 水平无统计学差异（中位数 ng/mL [四分位距]：0.043 [0.02-0.07] 与 0.042 [0.02-0.13]；P=0.56）。在检测后 7 天（n=7，5.6%）或 14 天（n=12，9.7%）发生 sPTB 的妇女中，PCT 水平也无统计学差异。此外，亚组分析显示，24 至 28 周、28 至 32 周和超过 32 周之间以及对照组之间，入院时的 PCT 水平无差异。基于受试者工作特征曲线，最高的灵敏度和特异性对应于 0.038ng/mL 的 PCT 浓度，而预测 7 或 14 天内 sPTB 的预测值较差。
在 24 至 36 周 TPL 入院的妇女中，血清 PCT 与 7 或 14 天内 sPTB 无关，因此 PCT 不是确认与早产分娩相关的炎症过程假说的合适生物标志物。
Clinicaltrials.gov（NCT01977079），2013 年 10 月 24 日注册。
