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NCT Number: NCT05935904

Progression of Metabolic Syndrome Components During Pregnancy

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

Current knowledge about MetS in pregnancy is limited, but it is generally accepted that obesity increases the risk of developing gestational diabetes mellitus (GDM) and preeclampsia (PE). Both of these are associated with an increased risk for developing type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) in women later in their life. Poor dietary quality, overweight and/or obesity defined by elevated body mass index (BMI ≥25 kg/m2), are the two most common risk factors associated with the development of MetS during pregnancy. MetS is a serious and escalating public health and clinical challenge in the wake of urbanization, surplus energy intake, and sedentary life habits. MetS during pregnancy can result in complications during pregnancy and can affect the birth outcomes resulting in preterm birth (PB) and fetal growth restriction (FGR) escalating the risk for perinatal mortality and morbidity as well as increasing the risk of developing chronic diseases later in life. Identifying early in pregnancy the unfavourable maternal conditions that can predict poor birth outcomes could help their prevention and management and will warrant a close follow-up for these women from long-term complications. Hence the development of context- and population-specific indicators that define the MetS risk in this population is important in the design of interventions that will be targeting the prevention of MetS.

Study objectives: This study aims to investigate the progression of MetS components during pregnancy, and the associations of MetS components with adverse pregnancy outcomes in the mother-infant cohort study southwest Ethiopia.

Primary aim:

To assess the relationship between maternal MetS components and adverse pregnancy outcomes.

Secondary aima:

i) To assess the progression of MetS components during pregnancy, and the underlying risk factors.

ii) To assess the associations between MetS components during early- and late pregnancy and adverse pregnancy outcomes.

iii) To explore knowledge, attitude and practices toward maternal dietary habits, food taboos, and cultural beliefs during pregnancy.

iv) To develop and validate body composition cut-offs for predicting obesity (as a risk factor for MetS) among Ethiopian pregnant women.

Methodology: A prospective maternal-infant cohort study will be conducted at the Jimma Medical Center, southwest Ethiopia.

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.

Recruitment will be at one of the following centers including Jimma Medical center, Shenen Gibe General Hospital, Family Guidance Associations (FGA) and two other health centers.

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.

Statistical analysis will be conducted using STATA. The progression of MetS components during pregnancy will be assessed using the repeated measures ANOVA procedure. Dietary data and physical activities will be tested as the main risk factors. Log binomial regression analyses will be used to examine the risk for each pregnancy outcome with each of the 5 individual components for MetS and as a composite measure (i.e., MetS). The relative risks, adjusted for maternal body mass index (BMI), age, ethnicity, socioeconomic index, physical activity, smoking status, and fetal sex, will be examined.

Additionally, adapted analyses will be used to define the cutoffs of obesity in this population using maternal body composition data (fat mass and fat-free mass)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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).

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.

Treatment and study plan

Exposure

Other

Dietary habits:

Data collected using food frequency questionnaire

Risk factors associated with metabolic syndrome:

Data collected on nutritional status, biochemical indicators and other risk factors associated with metabolic syndrome progression during pregnancy

Pregnancy outcomes:

Adverse pregnancy and birth outcomes.

Other names: MetS_Risk

Non exposure

Other

Dietary habits:

Data collected using food frequency questionnaire

Risk factors associated with metabolic syndrome:

Data collected on nutritional status, biochemical indicators and other risk factors associated with metabolic syndrome progression during pregnancy

Pregnancy outcomes:

Adverse pregnancy and birth outcomes.

Other names: MetS_Free

Primary outcomes

  1. Birth weight

    Time frame: Birth weight will be assessed up to 28 weeks after enrollment

    Birth weight (g)

  2. Infant length

    Time frame: Infant length will be assessed up to 28 weeks after enrollment

    Infant length (cm)

  3. Gestational age at birth

    Time frame: It is measured in weeks, from the first day of the woman's last menstrual cycle to the day of birth.

    Gestational age at birth in weeks will be used to define preterm (babies born alive prior to 37 completed weeks of gestation), term birth (birth between 37 and 42 weeks), and post-term (birth after 42 weeks of gestation).

  4. Preeclampsia (PE)

    Time frame: In all participating women up to 28 weeks after enrollment

    Defined as systolic BP >140 mm Hg or diastolic BP >90 mm Hg, or both, on at least 2 occasions at least 4 hours apart after 20 weeks' gestation but before the onset of labour, or postpartum, with either proteinuria (24-hour urinary protein >300 mg or spot urine protein:creatinine ratio >30 mg/mmol creatinine) or any multisystem complication of PE.

  5. Gestational diabetes (GDM)

    Time frame: In all participating women up to 28 weeks after enrollment

    Defined if fasting glucose of >5.1 mmol/l.

Secondary outcomes

  1. Infant head circumference

    Time frame: Infant head circumference will be assessed up to 28 weeks after enrollment

    Infant head circumference (cm)

  2. High triglyceride concentrations

    Time frame: At baseline and through follow-up up to 28 weeks after enrollment

    High triglyceride level [>150 milligrams per deciliter (mg/dL)]

  3. High-density lipoprotein (HDL) cholesterol

    Time frame: At baseline and through follow-up up to 28 weeks after enrollment

    HDL cholesterol concentrations <50 mg/dL

  4. High blood pressure

    Time frame: At baseline and through follow-up up to 28 weeks after enrollment

    Blood pressure > 130/85 mm Hg

  5. High levels of fasting blood sugar

    Time frame: At baseline and through follow-up up to 28 weeks after enrollment

    Fasting glucose > 105 mg/dL

  6. Maternal weight

    Time frame: Maternal weight will be measured at baseline

    Maternal weight (Kg)

  7. Maternal height

    Time frame: Maternal height will be measured at baseline

    Maternal height (cm)

  8. Dietary intake during six months pregnancy

    Time frame: Assessed at 12 weeks and 24 weeks after enrollment

    Prevalence of women with adequate dietary intake during six months pregnancy

Other outcomes

  1. Prevalence of participants with nutrition knowledge

    Time frame: At baseline in all participants

    Knowledge, attitudes and practices of dietary practices during pregnancy: Using a structured questionnaire, the knowledge, attitudes and practices of the women regarding food taboos and cultural norms during pregnancy will be assessed.

  2. Fat-free mass

    Time frame: At baseline in a sub-sample of participants

    Fat-free mass (Kg) will be measured using the BOD POD.

Study contacts

Contact information is provided by the study sponsor or research team.

Abonesh Taye Kumsa, MSc.

CONTACT

[email protected]

+251912046684

Souheila Abbeddou, MSc. PhD

CONTACT

[email protected]

+32467630892

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Flemish Interuniversity Council (VLIR)
  • Jimma University

Registry information

Official study title

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

Acronym: MetS_Preg

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2023
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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