NCT05935904 Progression of Metabolic Syndrome Components During Pregnancy
| NCT ID | NCT05935904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Metabolic Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 526 participants |
| Start Date | 2023-06-27 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 526 participants in total. It began in 2023-06-27 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Apparently healthy women with (or without) at least one of the 5 individual components of MetS will be enrolled in the study from each selected health institution if they meet all the inclusion criteria. Inclusion criteria for the exposed group include additionally: 1. Abdominal obesity defined as waist circumference ≥ 2 standard deviations (SD) for gestational age in the first half of pregnancy or presentational BMI \>30 kg/m2, OR 2. Raised triglycerides (\>1.70 mmol/l \[\>150 mg/dl\]), OR 3. Reduced high-density lipoprotein cholesterol (\<1.29 mmol/l \[\<50 mg/dl\]), OR 4. Raised blood pressure (BP) (i.e., systolic BP \>130 mm Hg or diastolic BP \>85 mm Hg), OR 5. Raised plasma glucose (\>5.6 mmol/l). Exclusion Criteria: * Pregnant women with chronic hypertension that necessitates medication, diabetes (also under medication), or any severe chronic illness will not be eligible to participate in the study. Women who have HIV and who take antiretroviral therapy (ART) are also not eligible because of the side effect of ART. Additionally, non-consenting women, ≤18 years old, women who are planning to move outside the study area within the study timeframe due to job transfer or study leave, or those who are not willing to adhere to the prospective follow up visits will not be included in the study. Women whose ultrasound confirmed, twin pregnancy, congenital anomaly or fetal death in utero will not be included in the study.
Contact & Investigator
Stefaan De Henauw, MD, MSc. PhD
PRINCIPAL INVESTIGATOR
University Ghent
Frequently Asked Questions
Who can join the NCT05935904 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05935904 currently recruiting?
Yes, NCT05935904 is actively recruiting participants. Contact the research team at Souheila.Abbeddou@UGent.Be for enrollment information.
Where is the NCT05935904 trial being conducted?
This trial is being conducted at Jimma, Ethiopia.
Who is sponsoring the NCT05935904 clinical trial?
NCT05935904 is sponsored by University Ghent. The principal investigator is Stefaan De Henauw, MD, MSc. PhD at University Ghent. The trial plans to enroll 526 participants.