Progression of Metabolic Syndrome Components During Pregnancy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity Ghent

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Pregnant women in their first trimester, who are residents of Jimma town and nearby kebeles (the smallest administrative division or municipality) will be contacted at the selected health institutions and asked to participate in the study. Eligible women who provide their consent will be recruited. Participants will be selected based on their exposure to one or more components of MetS or not. Sampling will be done consecutively until the required sample is reached.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Exposure

    Other intervention

    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.

  • Non exposure

    Other intervention

    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.

Treatment groups

526 Participants
are divided into 2 treatment groups
Group A: MetS_risk1 intervention
Group B: MetS_Free1 intervention

Trial outcomes

Primary outcomes

1

Birth weight

Birth weight (g)

Time frame
Birth weight will be assessed up to 28 weeks after enrollment
2

Infant length

Infant length (cm)

Time frame
Infant length will be assessed up to 28 weeks after enrollment
3

Gestational age at 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).

Time frame
It is measured in weeks, from the first day of the woman's last menstrual cycle to the day of birth.
4

Preeclampsia (PE)

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.

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

Secondary outcomes

1

Infant head circumference

Infant head circumference (cm)

Time frame
Infant head circumference will be assessed up to 28 weeks after enrollment
2

High triglyceride concentrations

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

Time frame
At baseline and through follow-up up to 28 weeks after enrollment
3

High-density lipoprotein (HDL) cholesterol

HDL cholesterol concentrations \<50 mg/dL

Time frame
At baseline and through follow-up up to 28 weeks after enrollment
4

High blood pressure

Blood pressure \> 130/85 mm Hg

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

Other outcomes

1

Prevalence of participants with nutrition knowledge

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.

Time frame
At baseline in all participants
2

Fat-free mass

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

Time frame
At baseline in a sub-sample of participants

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Ghent

Lead sponsor

Flemish Interuniversity Council (VLIR)

Collaborator

Jimma University

Collaborator