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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07299773
Status
Not Yet Recruiting

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Conditions

  • Hypertensive Disorder of Pregnancy
  • Preeclampsia
  • Preeclampsia (PE)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Dec 23, 2025
Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

prediction of preeclampsia with severe features [ Time Frame: at enrollment ]

Central Contacts

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