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NCT Number: NCT06720857

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

At the time of recruitment, patients will be adequately informed about the purpose and modality of the study and will sign an informed consent form for participation in the study. On the first postpartum day, on the occasion of the blood tests included in the normal care routine, the patients will undergo measurement of circulating levels of angiogenic factors (soluble fms-like tyrosine kinase, sFlt-1; placental growth factor, PlGF), already used in pregnancy for predicting the risk of early and late preeclampsia. Marker assay kits will be provided free of charge by the company DASIT. Prior to collection, systolic and diastolic blood pressure will be measured by manual sphygmomanometer in supine position after at least 15 minutes of rest.

Anamnestic, clinical and laboratory data regarding pregnancy, childbirth and puerperium will be collected.

A diary for recording blood pressure values in the puerperium will be provided on the same occasion. The patient will be instructed in home blood pressure monitoring which should take place twice a week for the next 6 weeks after delivery. Return of the diary containing the pressure data will be done by e-mail. Postpartum hypertension is defined according to ACOG criteria as a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. If altered blood pressure values are found, the patient will be invited to go to the emergency department or to her primary care physician and treated according the usual clinical practice.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: "From enrollment to the end of treatment (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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: SOMP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Dec 9, 2024

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.

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