Innovations in Placental Metabolism and Association With Antioxidants and Nutrients in Diabetes and Gestational Obesity

NCT05174728 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-05-14

No results posted yet for this study

Summary

This research project aims to investigate, in an innovative way, the molecular pathophysiology of gestational complications induced by maternal obesity and gestational diabetes mellitus (GDM). These complications have an immediate impact on obstetric outcomes - such as pre-eclampsia and intrauterine growth restriction - as well as long-term consequences for the health of the mother and child. This proposal aims to advance the understanding of the relationship between subclinical maternal and placental inflammation with dietary components through a prospective cohort of pregnant women. To this end, a prospective cohort of pregnant women will be conducted with four follow-up waves: 13th-20th (baseline), 24th-28th, 32nd-36th gestational weeks and at the time of delivery. Retrospective data referring to the first trimester of pregnancy will be obtained from the medical records. Pregnant women will be invited to participate in the study by registering at the prenatal service. Women who start prenatal care with less than 13 weeks of gestation will be registered, for capture in the 2nd consultation. The initial sample calculation is 120 volunteers. Maternal blood samples will be collected at 2 times: 2nd trimester appointment and 3rd trimester appointment. Placental and umbilical cord blood samples will be collected immediately after delivery. Dietary consumption during pregnancy will be assessed by 2 24-hour recalls at each visit (1 in person and 1 by telephone). The identification of functional biomarkers in maternal blood and placenta will serve for prognostic purposes of gestational complications such as Gestational Diabetes Mellitus. The identification of dietary factors associated with obesity and gestational diabetes mellitus and associated complications will provide information that will serve as a basis for nutritional guidelines for pregnant women.

Conditions

  • Pregnancy Complications
  • Obesity, Maternal
  • Diabetes Mel Gestational - in Pregnancy

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    collaborator OTHER_GOV
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV
  • University of Cambridge

    collaborator OTHER
  • Université Montpellier

    collaborator OTHER
  • Universidade Federal do Rio de Janeiro

    collaborator OTHER
  • Maternidade Escola da UFRJ

    collaborator UNKNOWN
  • Rio de Janeiro State University

    lead OTHER

Principal Investigators

  • Tatiana El-Bacha, DSc · UFRJ

  • Carolina S Ferreira, DSc · UFRJ

  • Deborah AB Guimarães, DSc · UFRJ

  • Gabriela DA Pinto, DSc · UFRJ

  • Vanessa A Goes, DSc · UFRJ

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2019-01-25
Completion
2024-12-31

Countries

  • Brazil

Study Locations

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Entities

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 NCT05174728 on ClinicalTrials.gov