Progression of Metabolic Syndrome Components During Pregnancy

NCT05935904 | Recruiting

• 1 other identifier: ONZ-2022-0563
• Study Type: observational
• Target: 526
• Locations: 1 country
• Sites: 1

Brief 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. 1.Sociodemographic data
2. 2.Dietary intake
3. 3.Biochemical analyses
4. 4.Maternal anthropometry:
5. 5.Body composition in a subsample.
6. 6.Knowledge, attitudes and practices of dietary practices during pregnancy
7. 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

Metabolic Syndrome; Pregnant Women; Birth Outcomes; Dietary Habits; Knowledge, Attitudes, Practice

Keywords

Metabolic syndrome; Cohort; Pregnancy; Birth outcomes; Food culture

Outcome Measures

Primary Outcomes (5)

• Birth weight

  Birth weight (g)

  Birth weight will be assessed up to 28 weeks after enrollment

• Infant length

  Infant length (cm)

  Infant length will be assessed up to 28 weeks after enrollment

• 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).

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

• 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.

  In all participating women up to 28 weeks after enrollment

• Gestational diabetes (GDM)

  Defined if fasting glucose of \>5.1 mmol/l.

  In all participating women up to 28 weeks after enrollment

Secondary Outcomes (8)

• Infant head circumference

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

• High triglyceride concentrations

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

• High-density lipoprotein (HDL) cholesterol

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

• High blood pressure

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

• High levels of fasting blood sugar

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

Other Outcomes (2)

• Prevalence of participants with nutrition knowledge

  At baseline in all participants

• Fat-free mass

  At baseline in a sub-sample of participants

Study Arms (2)

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.

Other: Exposure

MetS_Free

Pregnant women in their first trimester who are free of any MetS component.

Other: Non exposure

Interventions

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.

Also known as: MetS_Risk

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.

Also known as: MetS_Free

MetS_Free

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead
• Flemish Interuniversity Council (VLIR): collaborator
• Jimma University: collaborator

Study Sites (1)

Jimma University Medical Center

Jimma, Ethiopia

RECRUITING

Related Publications (7)

• Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.

  PMID: 9686693 BACKGROUND

• Muche AA, Olayemi OO, Gete YK. Gestational diabetes mellitus increased the risk of adverse neonatal outcomes: A prospective cohort study in Northwest Ethiopia. Midwifery. 2020 Aug;87:102713. doi: 10.1016/j.midw.2020.102713. Epub 2020 May 19.

  PMID: 32447182 BACKGROUND

• Vasilevski V, Carolan-Olah M. Food taboos and nutrition-related pregnancy concerns among Ethiopian women. J Clin Nurs. 2016 Oct;25(19-20):3069-75. doi: 10.1111/jocn.13319. Epub 2016 Jul 14.

  PMID: 27411855 BACKGROUND

• Berhe AK, Ilesanmi AO, Aimakhu CO, Mulugeta A. Effect of pregnancy induced hypertension on adverse perinatal outcomes in Tigray regional state, Ethiopia: a prospective cohort study. BMC Pregnancy Childbirth. 2019 Dec 31;20(1):7. doi: 10.1186/s12884-019-2708-6.

  PMID: 31892353 BACKGROUND

• Chatzi L, Plana E, Pappas A, Alegkakis D, Karakosta P, Daraki V, Vassilaki M, Tsatsanis C, Kafatos A, Koutis A, Kogevinas M. The metabolic syndrome in early pregnancy and risk of gestational diabetes mellitus. Diabetes Metab. 2009 Dec;35(6):490-4. doi: 10.1016/j.diabet.2009.07.003.

  PMID: 19897394 BACKGROUND

• Grieger JA, Bianco-Miotto T, Grzeskowiak LE, Leemaqz SY, Poston L, McCowan LM, Kenny LC, Myers JE, Walker JJ, Dekker GA, Roberts CT. Metabolic syndrome in pregnancy and risk for adverse pregnancy outcomes: A prospective cohort of nulliparous women. PLoS Med. 2018 Dec 4;15(12):e1002710. doi: 10.1371/journal.pmed.1002710. eCollection 2018 Dec.

  PMID: 30513077 BACKGROUND

• Aldridge E, Pathirana M, Wittwer M, Sierp S, Leemaqz SY, Roberts CT, Dekker GA, Arstall MA. Prevalence of Metabolic Syndrome in Women After Maternal Complications of Pregnancy: An Observational Cohort Analysis. Front Cardiovasc Med. 2022 Mar 14;9:853851. doi: 10.3389/fcvm.2022.853851. eCollection 2022.

  PMID: 35360031 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be collected at baseline, 6 months, and 9 months of pregnancy as well as after birth. Samples of blood will be analyzed for lipid profile and fasting blood glucose. Urine samples will be collected at baseline only for Human chorionic gonadotropin (HCG) test.

MeSH Terms

Conditions

Metabolic Syndrome; Feeding Behavior; Behavior

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior, Animal

Study Officials

• Stefaan De Henauw, MD, MSc. PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Souheila Abbeddou, MSc. PhD

CONTACT

+32467630892; Souheila.Abbeddou@UGent.Be

Abonesh Taye Kumsa, MSc.

CONTACT

+251912046684; AboneshTaye.Kumsa@UGent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 7, 2023
• Study Start: June 27, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)