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

NCT07299773 | Not Yet Recruiting

• 1 other identifier: 8162
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preeclampsia (PE); Preeclampsia; Hypertensive Disorder of Pregnancy

Keywords

preeclampsia; ophtalmic nerve; ophtalmic artery

Outcome Measures

Primary Outcomes (1)

• prediction of preeclampsia with severe features

  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.

  at enrollment

Study Arms (1)

preeclamptic women > 22 weeks

All eligible patients meeting inclusion criteria during the study period will be enrolled, as no sample-size calculation is feasible due to the absence of prior literature. 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 Study Procedures At enrollment and near delivery, all patients will undergo: 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): meas

Diagnostic Test: Doppler evaluation

Interventions

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.

preeclamptic women > 22 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

preeclamptic women \> 22 weeks

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Pre-Eclampsia; Toxemia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections

Central Study Contacts

Elvira Di Pasquo, Medical Doctor

CONTACT

003906301555589; elvira.dipasquo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12