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
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 - 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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