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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnancies complicated by preeclampsia or gestational hypertension ≥22 weeks

Age ≥18 years

Signed informed consent

Disqualifiers

intrauterine fetal demise

Major fetal anomalies or chromosomal abnormalities

Maternal cardiac disease or ongoing cardiologic therapy

Chronic kidney disease

Trial population

preeclamptic women \> 22 weeks

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: preeclamptic women > 22 weeks1 intervention

Trial outcomes

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.

Time frame
at enrollment

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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