Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT05935904

Progression of Metabolic Syndrome Components During Pregnancy

Led by University Ghent · Updated on 2024-07-08

526

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

U

University Ghent

Lead Sponsor

F

Flemish Interuniversity Council (VLIR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Progression of Metabolic Syndrome Components During Pregnancy

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy pregnant women attending their first antenatal care visit before 15 weeks of pregnancy
  • Women aged between 18 and 45 years
  • Women with or without at least one of the 5 metabolic syndrome components
  • For the exposed group, women with abdominal obesity (waist circumference ≥ 2 SD for gestational age or BMI >30 kg/m2), or raised triglycerides (>1.70 mmol/l), or low HDL cholesterol (<1.29 mmol/l), or raised blood pressure (systolic >130 mm Hg or diastolic >85 mm Hg), or raised plasma glucose (>5.6 mmol/l)
Not Eligible

You will not qualify if you...

  • Women with chronic hypertension requiring medication
  • Women with diabetes under medication
  • Women with severe chronic illness
  • Women with HIV taking antiretroviral therapy (ART)
  • Women younger than 18 years
  • Women planning to move outside the study area during the study period
  • Women unwilling to follow up during the study
  • Women with ultrasound confirmed twin pregnancy
  • Women with fetal congenital anomaly or fetal death in utero

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jimma University Medical Center

Jimma, Ethiopia

Actively Recruiting

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Research Team

S

Souheila Abbeddou, MSc. PhD

CONTACT

A

Abonesh Taye Kumsa, MSc.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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