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

Predictive Value for Preeclampsia of the sFlt-1:PlGF (Soluble Foms-like Tyrosine Kinase 1/Placental Growth Factor) Ratio in Pregnancy Complicated by Gestational Diabetes: The PREDICTION (PREeclampsia in DIabetiC gestaTION) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia; Gestational Diabetes; Gestational Hypertension

Detailed Description

Single center, observational, prospective study designed to validate a cutoff point of the sFlt-1:PlGF ratio for the prediction of the short-term absence or presence of preeclampsia in pregnancy complicated by gestational diabetes (GDM).

GDM women will be recruited at diabetes screening time (16-18 or 24-27 gestational weeks), performed according with the Italian National Guidelines by 75g - 2 hour Oral Glucose Tolerance Test. GDM will be defined according with International Association of Diabetes and Pregnancy Study Groups/World Health Organization 2013 criteria. A standardized medical history will be obtained in all the women at the time of their first visit, collecting data about maternal age, parity, last menstruation, pre-gestational weight, history of GDM, hypertension and macrosomia in previous pregnancies, family history of diabetes mellitus, education and employment. Moreover, during their visit, the women's weights were taken and their blood pressure measured. Blood samples for assessments of sFlt-1:PlGF ratio will be collected at visit 1 (baseline visit) and every 30±7 days after the previous visit until 36 gestational week (for a maximum of 4 determinations). At baseline and at each follow-up visits update of medical history, clinical assessments, laboratory testing and pregnancy evolution will be evaluated. During pregnancy all women will be receive standard diabetes and obstetric care, according with national guidelines. Diagnostic criteria for preeclampsia will be a new onset of both hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or both) and proteinuria (2+ protein or greater on dipstick urinalysis, ≥300 mg of protein per 24-hour urine collection, ≥30 mg /dl of protein in a spot urine sample, or a ratio of protein to creatinine of ≥30 mg/mmol) after 20 weeks of gestation. Only cases that met these prespecified criteria will be included in the analyses. At delivery, data items on maternal body weight at the end of pregnancy, time and mode of delivery, newborn bodyweight, preeclampsia as well as other maternal and fetal outcomes will be collected. Placental histopathological alterations will be detected in women who delivery by planned Cesarian section.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Cristina Bianchi, MD, PhD; Phone Number: +39050995136; Email: c.bianchi@ao-pisa.toscana.it

Study Locations

• Italy
  • PI
    • Pisa, PI, Italy, 56124
      • Recruiting
      • Azienda Ospedaliero-Universitaria Pisana - U.O. Malattie Metaboliche e Diabetologia
      • Contact: Cristina Bianchi, MD, PhD; Phone Number: +39050995136; Email: c.bianchi@ao-pisa.toscana.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women with gestational diabetes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between SFLT-1 / PLGF ratio and placental histopathology	Correlation between SFLT-1 / PLGF ratio and rate of placental histopathological alterations in pregnancy complicated by diabetes (pre-pregnancy or gestational)	25 weeks

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2019
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (ACTUAL): May 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Hypertension; Diabetes Mellitus; Eclampsia; Pre-Eclampsia; Diabetes, Gestational; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 14905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No