Clinical Trial

Progression of Metabolic Syndrome Components During Pregnancy

Study acronym: MetS_Preg
Unknown
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Record status
This record was last updated July 8, 2024 (before its estimated December 30, 2024 completion). Its status may not reflect the trial's current state.
Summary
The goal of this cohort study is to investigate the underlying risk factors to develop metabolic syndrome (MetS) during pregnancy, and the associations of MetS and its indicators with birth outcomes in southwest Ethiopia. The study population consists of low-risk pregnant ladies in their first antenatal care visit (ANC), from Jimma Medical center. The main question\[s\] it aims to answer are: i) How do MetS components progress during pregnancy, and what are the underlying risk factors? ii) What is the association between MetS components during early- and late pregnancy and adverse pregnancy outcomes? iii) What is the knowledge, attitude and practices of women toward dietary habits, food taboos, and cultural beliefs during pregnancy? The study population consists of low-risk pregnant ladies in their first trimester (\<15 weeks of pregnancy) in their first antenatal care visit (ANC) who will be followed up until one-month postpartum. Enrolled women will be assessed four times: at enrolment ≤15 weeks of pregnancy, mid-pregnancy (at 24 weeks), and late pregnancy (at 36 weeks), and within two weeks post-partum for: 1. Sociodemographic data 2. Dietary intake 3. Biochemical analyses 4. Maternal anthropometry: 5. Body composition in a subsample. 6. Knowledge, attitudes and practices of dietary practices during pregnancy 7. Pregnancy and birth outcomes: During the final visit, new born babies will be assessed for Apgar score, weight, length, and head circumference. The mother will be examined for general health and mode of delivery.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT05935904
Lead Sponsor University Ghent
Collaborators: Flemish Interuniversity Council (VLIR), Jimma University
Conditions Metabolic Syndrome, Pregnant Women, Birth Outcomes, Dietary Habits, Knowledge, Attitudes, Practice
Enrollment 526 participants
Start Date 2023-06-27
Primary Completion 2024-12-30 (estimated)
Study Completion 2024-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-07-08