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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

⁃ 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

⁃ Raised triglycerides (\>1.70 mmol/l \[\>150 mg/dl\]), OR

⁃ Reduced high-density lipoprotein cholesterol (\<1.29 mmol/l \[\<50 mg/dl\]), OR

⁃ Raised blood pressure (BP) (i.e., systolic BP \>130 mm Hg or diastolic BP \>85 mm Hg), OR

⁃ Raised plasma glucose (\>5.6 mmol/l).

Locations
Other Locations
Ethiopia
Jimma University Medical Center
RECRUITING
Jimma
Contact Information
Primary
Souheila Abbeddou, MSc. PhD
Souheila.Abbeddou@UGent.Be
+32467630892
Backup
Abonesh Taye Kumsa, MSc.
AboneshTaye.Kumsa@UGent.be
+251912046684
Time Frame
Start Date: 2023-06-27
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 526
Treatments
MetS_risk
Pregnant women in their first trimester who have one or more of the following risk factors: 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; triglycerides concentration \>150 mg/dl; HDL cholesterol concentrations \<50 mg/dL; fasting glucose \> 105 mg/dL; and blood pressure \> 130/85 mm Hg.
MetS_Free
Pregnant women in their first trimester who are free of any MetS component.
Related Therapeutic Areas
Sponsors
Leads: University Ghent
Collaborators: Jimma University, Flemish Interuniversity Council (VLIR)

This content was sourced from clinicaltrials.gov