Obstetrics and Gynecology Department, Health Faculty, Universidad Industrial de Santander, Bucaramanga, Colombia
Maternal-fetal Medicine Unit, Hospital Universitario de Santander, Bucaramanga, Colombia.
BMJ Open. 2022 May 30;12(5):e060556. doi: 10.1136/bmjopen-2021-060556.
Preterm birth (PTB) is a public health issue. Interventions to prolong the length of gestation have not achieved the expected results, as the selection of population at risk of PTB is still a challenge. Cervical length (CL) is the most accepted biomarker, however in the best scenario the CL identifies half of the patients. It is unlikely that a single measure identifies all pregnant women who will deliver before 37 weeks of gestation, considering the multiple pathways theory. We planned this cohort to study the link between the vaginal microbiome, the proteome, metabolome candidates, characteristics of the cervix and the PTB.
Pregnant women in the first trimester of a singleton pregnancy are invited to participate in the study. We are collecting biological samples, including vaginal fluid and blood from every patient, also performing ultrasound measurement that includes Consistency Cervical Index (CCI) and CL. The main outcome is the delivery of a neonate before 37 weeks of gestation.
We have recruited 244 pregnant women. They all have measurements of the CL and CCI. A vaginal sample for microbiome analysis has been collected in the 244 patients. Most of them agreed to blood collection, 216 (89%). By August 2021, 100 participants had already delivered. Eleven participants (11 %) had a spontaneous PTB.
A reference value chart for the first trimester CCI will be created. We will gather information regarding the feasibility, reproducibility and limitations of CCI. Proteomic and metabolomic analyses will be done to identify the best candidates, and we will validate their use as predictors. Finally, we plan to integrate clinical data, ultrasound measurements and biological profiles into an algorithm to obtain a multidimensional biomarker to identify the individual risk for PTB.
早产（PTB）是一个公共卫生问题。延长妊娠时间的干预措施并未达到预期效果，因为选择有早产风险的人群仍然是一个挑战。宫颈长度（CL）是最被接受的生物标志物，但在最佳情况下，CL 仅能识别出一半的患者。考虑到多途径理论，不太可能有一种单一的方法就能识别出所有将在 37 周妊娠前分娩的孕妇。我们计划进行这项队列研究，以研究阴道微生物组、蛋白质组、代谢组候选物、宫颈特征与 PTB 之间的联系。
邀请单胎妊娠的孕妇参加这项研究。我们正在收集生物样本，包括每位患者的阴道液和血液，还进行包括一致性宫颈指数（CCI）和 CL 在内的超声测量。主要结果是在 37 周妊娠前分娩新生儿。
我们已经招募了 244 名孕妇。她们均进行了 CL 和 CCI 的测量。244 名患者均采集了阴道样本进行微生物组分析。大多数人都同意采血，有 216 人（89%）同意。截至 2021 年 8 月，已有 100 名参与者分娩。11 名参与者（11%）发生自发性 PTB。
将创建一个关于妊娠早期 CCI 的参考值图表。我们将收集有关 CCI 的可行性、可重复性和局限性的信息。将进行蛋白质组学和代谢组学分析，以确定最佳候选物，并验证其作为预测因子的用途。最后，我们计划将临床数据、超声测量和生物学特征整合到一个算法中，以获得多维生物标志物来识别个体 PTB 风险。
