Metabolic SyndromeMetS_PregNCT05935904
Progression of Metabolic Syndrome Components During Pregnancy
An observational study of Metabolic Syndrome and Pregnant Women, run by University Ghent at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Pregnant Women, Birth Outcomes
- What is being tested?
- Exposure and Non exposure
- How many people
- 526 participants
- Where
- 1 siteEthiopia
- Study dates
- 27 Jun 2023to 30 Dec 2024
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Jimma University Medical Center
Jimma
Fetiya Awol, MD., 251945809325, fetiya.awol@ju.edu.et
Melkamu Berhane, MD., +251912066170, melkamuarefayine@gmail.com
About this study
Official 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.
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:
Read more
- 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:
- Sociodemographic data
- Dietary intake
- Biochemical analyses
- Maternal anthropometry:
- Body composition in a subsample.
- Knowledge, attitudes and practices of dietary practices during pregnancy
- 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.
Read the detailed description
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:
- 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)
- Conditions
- Metabolic Syndrome, Pregnant Women, Birth Outcomes, Dietary Habits, Knowledge, Attitudes, Practice
- Being tested
- Exposure, Non exposure
- Keywords
- Metabolic syndrome, Cohort, Pregnancy, Birth outcomes, Food culture
- Medical subject headings
- Metabolic Syndrome, Feeding Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposureOther
Also called MetS_Risk
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 exposureOther
Also called MetS_Free
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exposure | |
| MetS_Free | Pregnant women in their first trimester who are free of any MetS component. Receives: Other: Non exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
Birth weight (g)
Measured: Birth weight will be assessed up to 28 weeks after enrollment
Infant length
Infant length (cm)
Measured: 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).
Measured: 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.
Measured: In all participating women up to 28 weeks after enrollment
Gestational diabetes (GDM)
Defined if fasting glucose of >5.1 mmol/l.
Measured: In all participating women up to 28 weeks after enrollment
Secondary outcomes (8)
Infant head circumference
Infant head circumference (cm)
Measured: Infant head circumference will be assessed up to 28 weeks after enrollment
High triglyceride concentrations
High triglyceride level [>150 milligrams per deciliter (mg/dL)]
Measured: At baseline and through follow-up up to 28 weeks after enrollment
High-density lipoprotein (HDL) cholesterol
HDL cholesterol concentrations <50 mg/dL
Measured: At baseline and through follow-up up to 28 weeks after enrollment
High blood pressure
Blood pressure > 130/85 mm Hg
Measured: At baseline and through follow-up up to 28 weeks after enrollment
High levels of fasting blood sugar
Fasting glucose > 105 mg/dL
Measured: At baseline and through follow-up up to 28 weeks after enrollment
Maternal weight
Maternal weight (Kg)
Measured: Maternal weight will be measured at baseline
Maternal height
Maternal height (cm)
Measured: Maternal height will be measured at baseline
Dietary intake during six months pregnancy
Prevalence of women with adequate dietary intake during six months pregnancy
Measured: Assessed at 12 weeks and 24 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start27 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 526 participants (estimated)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Jimma University
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, MD, MSc. PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935904
- Sponsor's protocol ID
- ONZ-2022-0563
- Acronym
- MetS_Preg
- Status last verified
- Jul 2024
- First submitted
- 16 Jun 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data both from the main and the secondary outcomes will be used in the analyses and shared as necessary.
Publications
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.
PubMed 9686693Muche 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.
PubMed 32447182Vasilevski 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.
PubMed 27411855Berhe 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.
PubMed 31892353Chatzi 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.
PubMed 19897394Grieger 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.
PubMed 30513077Aldridge 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.
PubMed 35360031
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05935904
- Acronym / sponsor ID
- MetS_Preg / ONZ-2022-0563
- Conditions
- Metabolic Syndrome, Pregnant Women, Birth Outcomes, Dietary Habits, Knowledge, Attitudes, Practice
- Keywords
- Metabolic syndrome, Cohort, Pregnancy, Birth outcomes, Food culture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Jimma University
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Sociodemographic data
- Dietary intake
- Biochemical analyses
- Maternal anthropometry:
- Body composition in a subsample.
- Knowledge, attitudes and practices of dietary practices during pregnancy
- 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.
Detailed description
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:
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MetS_risk | – | Other: ExposurePregnant 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 | – | Other: Non exposurePregnant women in their first trimester who are free of any MetS component. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExposureAlso: MetS_RiskDietary 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 | MetS_risk |
| Non exposureAlso: MetS_FreeDietary 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 | MetS_Free |
Primary outcome
Birth weight
Time frame: Birth weight will be assessed up to 28 weeks after enrollment
Birth weight (g)
Infant length
Time frame: Infant length will be assessed up to 28 weeks after enrollment
Infant length (cm)
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).
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.
Gestational diabetes (GDM)
Time frame: In all participating women up to 28 weeks after enrollment
Defined if fasting glucose of >5.1 mmol/l.
8 secondary outcomes
Infant head circumference
Time frame: Infant head circumference will be assessed up to 28 weeks after enrollment
High triglyceride concentrations
Time frame: At baseline and through follow-up up to 28 weeks after enrollment
High-density lipoprotein (HDL) cholesterol
Time frame: At baseline and through follow-up up to 28 weeks after enrollment
High blood pressure
Time frame: At baseline and through follow-up up to 28 weeks after enrollment
High levels of fasting blood sugar
Time frame: At baseline and through follow-up up to 28 weeks after enrollment
Maternal weight
Time frame: Maternal weight will be measured at baseline
Maternal height
Time frame: Maternal height will be measured at baseline
Dietary intake during six months pregnancy
Time frame: Assessed at 12 weeks and 24 weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 9686693Alberti 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.
- Background: PubMed 32447182Muche 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.
- Background: PubMed 27411855Vasilevski 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.
- Background: PubMed 31892353Berhe 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.
- Background: PubMed 19897394Chatzi 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.
- Background: PubMed 30513077Grieger 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.
- Background: PubMed 35360031Aldridge 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.
- Individual participant dataSharing planned: No. All the data both from the main and the secondary outcomes will be used in the analyses and shared as necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefaan De Henauw, MD, MSc. PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Pregnant Women, run by University Ghent at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Souheila Abbeddou, MSc. PhD (+32467630892, Souheila.Abbeddou@UGent.Be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight (time frame: Birth weight will be assessed up to 28 weeks after enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935904, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.