Department of Obstetrics and Gynecology, North Zealand Hospital, Hillerød, Denmark.
Department of Clinical Biochemistry Pharmacology, Odense University Hospital, Odense, Denmark.
Reprod Sci. 2023 Dec;30(12):3597-3609. doi: 10.1007/s43032-023-01323-8. Epub 2023 Aug 28.
This study aimed to develop a dynamic model for predicting outcome during the first trimester of pregnancy using baseline demographic data and serially collected blood samples and transvaginal sonographies. A prospective cohort of 203 unselected women with an assumed healthy pregnancy of < 8 weeks' gestation was followed fortnightly from 4-14 weeks' gestation until either miscarriage or confirmed first trimester viability. The main outcome was development of a model to predict outcome from gestational age-dependent hazard ratios using both baseline and updated serial data from each visit. Secondary outcomes were descriptions of risk factors for miscarriage. The results showed that 18% of the women experienced miscarriages. A fetal heart rate detected before 8 weeks' gestation indicated a 90% (95% CI 85-95%) chance of subsequent delivery. Maternal age (≥ 35 years), insufficient crown-rump-length (CRL) and mean gestational sac diameter (MSD) development, and presence of bleeding increased the risk of miscarriage. Serum biomarkers, including hCG, progesterone, and estradiol, were found to impact the risk of miscarriage with estradiol as the most important. The best model to predict miscarriage was a combination of maternal age, vaginal bleeding, CRL, and hCG. The second-best model was the sonography-absent model of maternal age, bleeding, hCG, and estradiol. This study suggests that combining maternal age, and evolving data from hCG, estradiol, CRL, and bleeding could be used to predict fetal outcome during the first trimester of pregnancy.Trial registration ClinicalTrials.gov identifier: NCT02761772.
本研究旨在利用基线人口统计学数据和连续采集的血液样本和经阴道超声，建立一种预测妊娠早期结局的动态模型。一个由 203 名未经选择的、假定健康的妊娠<8 周的孕妇组成的前瞻性队列，从妊娠 4-14 周起每两周随访一次，直到流产或确认妊娠 12 周的存活率。主要结局是建立一种使用基线和每次就诊的更新连续数据预测妊娠年龄依赖性风险比的模型。次要结局是描述流产的危险因素。结果显示，18%的女性经历了流产。在 8 周之前检测到胎儿心率表明随后分娩的可能性为 90%（95%置信区间 85-95%）。母亲年龄（≥35 岁）、不足的头臀长（CRL）和平均孕囊直径（MSD）发育、出血增加了流产的风险。包括 hCG、孕酮和雌二醇在内的血清生物标志物被发现对流产风险有影响，其中雌二醇最重要。预测流产的最佳模型是结合母亲年龄、阴道出血、CRL 和 hCG。第二个最佳模型是母龄、出血、hCG 和雌二醇的超声缺失模型。本研究表明，结合母亲年龄和 hCG、雌二醇、CRL 和出血的演变数据，可以预测妊娠早期的胎儿结局。试验注册临床Trials.gov 标识符：NCT02761772。
