Investigating metabolic syndrome during pregnancy

The Progression of Metabolic Syndrome Components During Pregnancy, and the Risks for Adverse Pregnancy Outcomes in Jimma Zone, Southwest Ethiopia: A Prospective Cohort Study.

This study looks at how metabolic syndrome affects low-risk pregnant women and their babies by tracking their diet and health from early pregnancy to a month after giving birth.

Quick facts

• Study type: Observational
• Enrollment: 526 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University Ghent (Academic / other)
• Locations: 1 site (Jimma)
• Trial ID: NCT05935904 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to explore the progression of metabolic syndrome (MetS) components in low-risk pregnant women during their pregnancy and the associations of these components with birth outcomes. The study will follow women from their first antenatal care visit until one month postpartum, assessing their dietary habits, knowledge, attitudes, and practices related to food during pregnancy. By identifying risk factors and the impact of MetS on pregnancy outcomes, the study seeks to develop specific indicators for this population to inform preventive measures and interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are low-risk pregnant women in their first trimester attending their first antenatal care visit.

Not a fit: Patients with chronic hypertension requiring medication, diabetes under treatment, or severe chronic illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and prevention strategies for metabolic syndrome during pregnancy, enhancing maternal and fetal health outcomes.

How similar studies have performed: While knowledge about metabolic syndrome in pregnancy is limited, similar studies have indicated the importance of addressing obesity and dietary factors, suggesting potential for success in this approach.

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.

Where this trial is running

Jimma

• Jimma University Medical Center — Jimma, Ethiopia (Recruiting)

Study contacts

• Principal investigator: Stefaan De Henauw, MD, MSc. PhD — University Ghent
• Study coordinator: Souheila Abbeddou, MSc. PhD

Conditions Metabolic Syndrome; Pregnant Women; Birth Outcomes; Dietary Habits; Knowledge, Attitudes, Practice; Metabolic syndrome; Cohort; Pregnancy