sFlt-1:PlGF Ratio in Gestational Diabetes: PREDICTION (PREeclampsia in DIabetiC gestaTION) Study

NCT04877119 | Unknown

• 1 other identifier: 14905
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) is elevated in pregnant women before the clinical onset of preeclampsia and can be used to predict the preeclampsia. However, its predictive value in pregnancy complicated by gestational diabetes is unclear. This study purposes are to validate a ratio of serum sFlt-1 to PlGF that would be predictive of the absence or presence of preeclampsia in the short term in women with singleton pregnancies complicated by diabetes in whom preeclampsia was suspected, and to evaluate the relationship among sFlt-1 to PlGF and placental histopathological alterations.

Conditions

Gestational Diabetes; Gestational Hypertension; Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• Predictive SFLT-1 / PLGF ratio cat-off point for preeclampsia

  Evaluation of a specific SFLT-1 / PLGF ratio cat-off point for women with diabetes during pregnancy (pre-pregnancy or gestational) in the prediction of preeclampsia

  25 weeks

Secondary Outcomes (1)

• Correlation between SFLT-1 / PLGF ratio and placental histopathology

  25 weeks

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women with gestational diabetes

You may qualify if:

• Age \> 18 years
• Diagnosis of GDM in the current pregnancy

You may not qualify if:

• Twin pregnancies
• Pre-pregnancy diabetes (type 1 or type 2 diabetes)
• Gestosis already diagnosed during the current pregnancy

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana - U.O. Malattie Metaboliche e Diabetologia

Pisa, PI, 56124, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Cristina Bianchi, MD, PhD

CONTACT

+39050995136; c.bianchi@ao-pisa.toscana.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 7, 2021
• Study Start: October 14, 2019
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)