Service de Gynécologie-Obstétrique, CHU de Nantes, Nantes, France.
Service de Gynécologie-Obstétrique, CHD Vendée, La Roche sur Yon, France.
BMC Pregnancy Childbirth. 2020 Aug 3;20(1):442. doi: 10.1186/s12884-020-03129-x.
Threatened preterm delivery (TPD) is the leading cause of inpatient admissions during pregnancy. The ability to predict the risk of imminent preterm delivery is thus a major priority in obstetrics. The aim of our study is to assess the diagnostic performance of the test to detect the placental alpha microglobulin 1 (PAMG-1) for the prediction of delivery within 7 days in women with TPD.
This is a prospective multicenter diagnostic study. Inclusion criteria are singleton pregnancy, gestational age between 24 + 0 and 33 + 6 weeks inclusive, cervical measurement 25 mm or less assessed by transvaginal ultrasound (with or without uterine contractions), clinically intact membranes and cervical dilatation < 3 cm assessed by digital examination. According to the current protocol, when a women presents with TPD and the diagnosis is confirmed by transvaginal ultrasound, a vaginal sample to test for genital infection is performed. At the same time, the midwife will perform the PartoSure® test. To perform this analysis, a sample of cervicovaginal secretions is taken with the vaginal swab furnished in the test kit. The primary outcome is the specificity of the PartoSure® test of women who gave birth more than 7 days after their hospitalization for TPD. The secondary outcomes are the sensitivity, PPV, and NPV of the Partosure® test and the factors associated with false positives (with a univariate logistic regression model). Starting with the hypothesis of an anticipated specificity of 89%, if we want to estimate this specificity with a confidence interval of ± 5%, we will require 151 women who do not give birth within 7 days. We therefore decided to include 400 women over a period of two years to have a larger number of events (deliveries within 7 days).
The different tests already used such as fetal fibronectin and phIGFBP-1, are not sufficiently relevant to recommend their use in daily practice. The different studies of PAMG-1 described above thus provide support for the use of this substance, tested by PartoSure®. Nonetheless, other larger studies are necessary to validate its use in daily practice and our study could answer this question.
NCT03401255 (January 15, 2018).
早产威胁（TPD）是孕妇住院的主要原因。因此，预测即将发生的早产风险是产科的主要重点。我们的研究目的是评估检测胎盘α微球蛋白 1（PAMG-1）用于预测 TPD 妇女在 7 天内分娩的诊断性能。
这是一项前瞻性多中心诊断研究。纳入标准为单胎妊娠，妊娠龄在 24+0 至 33+6 周之间，经阴道超声评估宫颈测量值为 25mm 或以下（有或无子宫收缩），临床完整的胎膜和经阴道检查评估宫颈扩张<3cm。根据目前的方案，当孕妇出现 TPD 且通过经阴道超声确诊时，会进行阴道样本检测以确定是否存在生殖道感染。同时，助产士将进行 PartoSure®检测。为了进行这项分析，用试剂盒中提供的阴道拭子采集宫颈阴道分泌物样本。主要结局是在 TPD 住院后超过 7 天分娩的女性的 PartoSure®检测的特异性。次要结局是 Partosure®检测的敏感性、PPV 和 NPV，以及与假阳性相关的因素（使用单变量逻辑回归模型）。基于预期特异性为 89%的假设，如果我们想以±5%的置信区间估计该特异性，我们将需要 151 名在 7 天内未分娩的女性。因此，我们决定在两年内纳入 400 名女性，以获得更多的事件（7 天内分娩）。
上述已经使用的不同测试，如胎儿纤维连接蛋白和 phIGFBP-1，不够相关，不能推荐在日常实践中使用。上述对 PAMG-1 的不同研究为使用该物质（通过 PartoSure®检测）提供了支持。然而，需要进行其他更大规模的研究来验证其在日常实践中的应用，我们的研究可以回答这个问题。
NCT03401255（2018 年 1 月 15 日）。
