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临床试验/NCT07299773
NCT07299773尚未招募不适用

Evaluation of Patients With Hypertensive Disorders of Pregnancy: An Ambispective Observational Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 120 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
prediction of preeclampsia with severe features

研究概览

简要总结

The overall objective of this study is to evaluate the prognostic role of ultrasound and laboratory parameters, specifically their potential ability to predict severe forms of preeclampsia and adverse maternal-fetal outcomes.

In particular, the aim of the present research is to obtain data on the prognostic value of ultrasonographic and biochemical parameters in patients with hypertensive disorders of pregnancy.

详细描述

This is an ambispective, observational cohort study conducted at a national tertiary obstetric center. This study investigates maternal hemodynamic, Doppler, ultrasound, and biochemical parameters as potential predictors of disease progression in women with gestational hypertension or preeclampsia. The study integrates non-invasive cardiovascular monitoring, placental biomarkers, ophthalmic and uterine artery Doppler velocimetry, carotid flow time index (CFTI), optic nerve sheath diameter (ONSD), and lung ultrasound.

The primary objective is to evaluate the prognostic performance of these parameters in predicting severe forms of preeclampsia and adverse maternal or perinatal outcomes. Secondary objectives include assessing the utility of lung ultrasound and carotid Doppler in characterizing maternal fluid status and supporting clinical decision-making regarding fluid management.

At enrollment and near delivery, participants undergo the following assessments:

  1. Non-invasive Maternal Hemodynamics (USCOM-1A) Parameters include heart rate, stroke volume, cardiac output, total vascular resistance, inotropy index, pulse pressure, and peripheral vascular measurements. Values will be converted to Z-scores using gestational age-adjusted reference curves where applicable.
  2. Placental Biomarkers Maternal blood samples are collected to determine the sFlt-1/PlGF ratio as an indicator of angiogenic imbalance.
  3. Uterine Artery Doppler Uterine artery systolic peak velocities and pulsatility index are measured bilaterally using standardized transabdominal technique.
  4. Ophthalmic Artery Doppler and ONSD Bilateral ophthalmic artery velocimetry is performed in a supine position to assess intracranial vascular impedance. Optic nerve sheath diameter is measured 3 mm behind the globe using a linear probe.
  5. Carotid Doppler (CFTI) Carotid flow time index is measured at baseline and after a passive leg raise (PLR) maneuver. A PLR-induced ΔCFTI of 10-15% is explored as a surrogate of fluid responsiveness.
  6. Lung Ultrasound (POCUS) Eight thoracic zones are evaluated using a curvilinear probe. The presence and distribution of B-lines are recorded to identify early interstitial pulmonary edema.

Clinical, obstetric, laboratory, and therapeutic data are collected longitudinally until delivery. Maternal and neonatal outcomes include timing of delivery, mode of delivery, birthweight, neonatal morbidity, and the interval between diagnosis and delivery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnancies complicated by preeclampsia or gestational hypertension ≥22 weeks
  • Age ≥18 years
  • Signed informed consent

排除标准

  • intrauterine fetal demise
  • Major fetal anomalies or chromosomal abnormalities
  • Maternal cardiac disease or ongoing cardiologic therapy
  • Chronic kidney disease
  • Twin or multiple pregnancies
  • Pregestational diabetes

结局指标

主要结局

prediction of preeclampsia with severe features

时间窗: at enrollment

Correlation between: hemodynamic assessment using USCOM serum levels of the biochemical markers sFlt-1/PlGF Doppler velocimetry of the uterine arteries Doppler velocimetry of the ophthalmic artery ultrasound assessment of the optic nerve sheath diameter ultrasound evaluation of carotid artery blood flow using CFTI presence of B-lines on lung ultrasound and the incidence of preeclampsia with severe features.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Di Pasquo Elvira

Medical Doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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