Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07299773

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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:

  • 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.
  • Placental Biomarkers Maternal blood samples are collected to determine the sFlt-1/PlGF ratio as an indicator of angiogenic imbalance.
  • Uterine Artery Doppler Uterine artery systolic peak velocities and pulsatility index are measured bilaterally using standardized transabdominal technique.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Doppler evaluation

Diagnostic Test

Non-invasive hemodynamic assessment (USCOM-1A): HR, SV, CO, TVR, inotropy index, PKR, systolic and diastolic blood pressure.

Maternal blood testing for sFlt-1/PlGF ratio. Uterine artery Doppler: systolic peak and pulsatility index. Ophthalmic artery Doppler and ONSD measurement: performed bilaterally in supine position; PSV peaks and PSV ratio calculated.

Carotid Doppler (CFTI): measured at baseline and after PLR; ΔCFTI of 10-15% considered indicative of fluid responsiveness.

Lung ultrasound POCUS: evaluation of 8 thoracic zones using a curvilinear probe; ≥3 B-lines bilaterally considered positive for interstitial edema.

Primary outcomes

  1. prediction of preeclampsia with severe features

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elvira Di Pasquo, Medical Doctor

CONTACT

[email protected]

003906301555589

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: PREP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.