Predictive Value of SFlt-1/PlGF Ratio for the Diagnosis of Cardiovascular Disorders in the Puerperium: Pilot Study

NCT06720857 | Active Not Recruiting

• 1 other identifier: SOMP
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to identify a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks postpartum) by making use of a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data. The goal is to create a score that allows the clinician to identify those expectant mothers who at discharge are at increased risk of developing cardiovascular/hypertensive disorders.

Conditions

Cardiovascular Disorder; Puerperium; Disease

Keywords

SFlt-1/PlGF ratio

Outcome Measures

Primary Outcomes (1)

• Identification of a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks after delivery)

  Through a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy to predict preeclampsia), demographic, clinical and laboratory data.

  "From enrollment to the end of treatment (6 weeks after delivery)

Study Arms (1)

Hypertensive disorders in the puerperium

EXPERIMENTAL

Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium

Diagnostic Test: Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium

Interventions

Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium DIAGNOSTIC_TEST

Identification of a risk stratification model for cardiovascular/hypertensive disorders in the puerperium using a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data.

Hypertensive disorders in the puerperium

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18 years and \< 44 years
• Single pregnancy
• Understanding and obtaining informed consent

You may not qualify if:

• Language misunderstanding
• Twin pregnancies
• Inability to comply with study arrangements (e.g., inability to home recording of blood pressure values)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Puerperal Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Antonio Farina, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: April 6, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-10

Locations

IT (1)