Bertholdt Charline, Hossu Gabriela, Banasiak Claire, Beaumont Marine, Morel Olivier
Obstetric and Fetal Medicine Unit, CHRU Nancy, Nancy, France
Inserm IADI, Université de Lorraine, Nancy, France.
BMJ Open. 2020 Oct 19;10(10):e037751. doi: 10.1136/bmjopen-2020-037751.
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are two major pregnancy complications, related to chronic uteroplacental hypoperfusion. Nowadays, there is no screening or diagnostic test for uteroplacental vascularisation deficiency in pregnant women. Since 2004, 3 three-imensional power Doppler (3DPD) angiography has been used for the evaluation of uteroplacental vascularisation and three vascular indices are usually calculated: Vascularisation Index (VI), Flow Index (FI) and vascularisation-FI (VFI). A high intraobserver and interobserver reproducibility and a potential interest for placental function study were reported by our team and others.The main objective of our study is to determine differences in 3DPD indices at first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, PE (mild and severe) and IUGR in nulliparous women.
This is a national multicentre prospective cohort study conducted in four French maternity units. We expect to include 2200 women in a period of 36 months. The nulliparous pregnant women will be recruited during their first trimester consultation (11-13+6 gestation week (GW)).The 3DPD and uterine artery Doppler acquisition will be included in the current routine 11-13+6 GW ultrasound. Also, additional blood samples will be taken for biomarker analysis (PAPP-A and P1GF) and biological collection. Uteroplacental VIs (FI and VFI) will be measured. For each subgroup (uncomplicated pregnancy, PE and IUGR), mean values in 3DPD indices will be computed and compared using a pairwise t test with a Bonferroni correction p value adjustment.
The study was approved by the French Ethics Committee, the Comité de Protection des Personnes SUD MEDITERRANEE IV on 13 February 2018 with reference number 17 12 03. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.
NCT03342014; Pre-results. PHRCN-16-0567.
子痫前期（PE）和胎儿宫内生长受限（IUGR）是两种主要的妊娠并发症，与慢性子宫胎盘灌注不足有关。目前，尚无针对孕妇子宫胎盘血管化不足的筛查或诊断测试。自2004年以来，三维能量多普勒（3DPD）血管造影已用于评估子宫胎盘血管化，通常计算三个血管指数：血管化指数（VI）、血流指数（FI）和血管化-血流指数（VFI）。我们团队及其他研究团队报告了较高的观察者内和观察者间重复性以及胎盘功能研究的潜在价值。本研究的主要目的是确定初产妇中，妊娠结局定义为正常妊娠、PE（轻度和重度）和IUGR的孕妇在孕早期3DPD指数的差异。
这是一项在法国四个产科单位进行的全国多中心前瞻性队列研究。我们预计在36个月内纳入2200名女性。未生育的孕妇将在孕早期咨询时（妊娠11-13⁺⁶周（GW））招募。3DPD和子宫动脉多普勒采集将纳入当前常规的11-13⁺⁶GW超声检查。此外，还将采集额外的血样进行生物标志物分析（妊娠相关血浆蛋白A和胎盘生长因子）和生物样本收集。将测量子宫胎盘VI（FI和VFI）。对于每个亚组（正常妊娠、PE和IUGR），计算3DPD指数的平均值，并使用经Bonferroni校正p值调整的成对t检验进行比较。
该研究于2018年2月13日获得法国伦理委员会——地中海南部第四地区保护人类委员会批准，参考编号为17 12 03。本研究结果将发表在同行评审期刊上，并在相关会议上展示。
NCT03342014；预结果。PHRCN-16-0567。
