MedTrace Logo

Maternal and Fetal Metabolic Changes

NCT06288126 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 457

Last updated 2024-03-01

No results posted yet for this study

Summary

The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring.

Primary objectives:

* measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM
* ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits.
* Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia.

Secondary objectives:

* Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women.
* Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit).

The participants will be recruited during first trimester ultrasound after signing the informed consent.

Conditions

  • Pregnancy Related
  • Maternal-Fetal Relations
  • Metabolism Disorder, Glucose

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Principal Investigators

  • Tommaso Simoncini, MD. PhD. · University of Pisa

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-10-09
Completion
2021-01-18

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06288126 on ClinicalTrials.gov