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| ID | Type | Description | Link |
|---|---|---|---|
| 525/17 | Other Identifier | Poznan University of Medical Sciences - Bioethics Board |
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This prospective observational trial includes women with high risk pregnancies complicated with hyperglycemia in pregnancy and excessive body weight. The participants are enrolled when pregnant and monitored throughout pregnancy and delivery until the offspring is 6 months old. This research addresses the question which risk factors for non-communicable disorders such as hypertension, obesity, type 2 diabetes for a woman and her offspring can be detected during pregnancy and in early childhood.
The available epidemiological data clearly indicate a significant increase in the percentage of people with obesity and the metabolic syndrome in the population of women of reproductive age. These diseases predispose to the onset of type 2 diabetes at a young age and accelerate the risk of cardiovascular diseases, while in pregnant population they constitute a serious risk factor for gestational diabetes.
Recent decades have brought a growing amount of evidence from prospective studies indicating the adverse impact of gestational diabetes on the health prognosis of the mother and her child. In the short-term perspective, hyperglycemia in pregnancy constitutes a risk factor for numerous maternal-fetal complications, in particular hypertensive diseases in pregnancy, excessive fetal growth, intrapartum complications induced by excessive birth weight of the newborn, which can result in intrapartum neonatal asphyxia or maternal postpartum haemorrhage. Gestational diabetes is also associated with an increased risk of fetal intrauterine death in late pregnancy, during delivery or postpartum.
However, there is growing evidence of the adverse effects of gestational diabetes on long-term health outcomes of the mother and her offspring, even when glucose tolerance disorders are resolved after delivery. Hyperglycemia detected in pregnancy is a strong risk factor for the development of type 2 diabetes within several years after experiencing a complicated pregnancy. Moreover, maternal hyperglycemia has been shown to adversely affect the long-term risk of obesity, metabolic syndrome, pre-diabetes, and type 2 diabetes in the offspring of this pregnant population. This relationship is so clear that it is the exposure of the fetus to the abnormal intrauterine metabolic environment that is considered to be one of the leading causes of the significantly increased prevalence of the aforementioned civilization diseases among children and adolescents.
The authors of the study expect that the obtained results will provide important data enabling early identification of the population that can benefit most measurably from the diagnosis and possible treatment of conditions predisposing to the non-communicable diseases. The authors believe, that this study will identify specific maternal characteristics that could be targets for individualized interventions modifying risk factors of civilization diseases in mothers and their offspring. The authors expect that the measurable effect of the research will be achievable in the short term - in the form of reduction of maternal-fetal complications characteristic of pregnancy complicated with obesity and / or gestational diabetes (maternal "diabesity"), and in the long term - in the form of improvement of the incidence rates of non-communicable disorders in the population of pregnant women of a risk profile similar to this presented by the cohort included in the study.
Research objectives:
The protocol includes the following visits:
V0 - recruitment, V1 - gestational age 28-32 weeks, V2 - gestational age 36-38 weeks, V3 - delivery, V4 - six weeks postpartum, V5 - six months postpartum
At the V0, the researchers will collect detailed information concerning demographics, anthropometrics, past diseases, pregnancy-related conditions, lifestyle and dietary habits
At the V1, V2, V4 and V5, the researchers collect data regarding maternal glucose levels and body weight, perform noninvasive tests of cardiovascular function and collect biological material to be aliquoted, frozen and stored for further examination of biomarkers of oxidative stress, fat tissue function, inflammation, insulin resistance, clotting system, cardiometabolic risk; also information regarding fetal growth (V1,V2) and child's anthropometrics and development (V4, V5) will be collected.
At the V3, the researchers collect a detailed information regarding delivery and neonatal anthropometrics, and collect samples of placenta and cord blood to be aliquoted, frozen and stored for further examination (see above).
At the V6, the researchers collect information regarding maternal dietary and lifestyle habits, perform noninvasive tests of cardiovascular function and collect biological material to be aliquoted, frozen and stored for further examination of biomarkers of oxidative stress, fat tissue function, inflammation, insulin resistance, clotting system, cardiometabolic risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOZART_SG | Women treated for hyperglycemia in pregnancy. Observational data are to be collected at follow-up visits during pregnancy, at delivery and postpartum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring and lifestyle | Behavioral | Dietary and lifestyle modification recommended for pregnant women with hyperglycemia detected in pregnancy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| maternal weight before delivery | kg | measured at term, within a week before delivery |
| maternal weight in the early pregnancy | kg | measured after a viable pregnancy confirmed until a gestational age of 12 weeks |
| birth weight | g | neonate's weight measured immediately after birth |
| Measure | Description | Time Frame |
|---|---|---|
| maternal blood pressure at the term | mmHg | measured at term, within a week before delivery |
| average maternal fasting glucose at the term | mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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Tertiary level of perinatal care unit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ewa Wender-Ożegowska, prof. | Contact | +4861859302 | klinrozrod.gpsk.um@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ewa Wender-Ożegowska, prof. | Head of the Department of Reproduction | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Reproduction, Poznan University of Medical Sciences | Recruiting | Poznan | 60-535 | Poland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D011254 | Pregnancy in Diabetics |
| D063766 | Pediatric Obesity |
| D046110 | Hypertension, Pregnancy-Induced |
| D004194 | Disease |
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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blood, serum, hair, cord blood
| measured seven times within two weeks before delivery |
| average maternal postprandial glucose at the term | mg/dl | measured one hour after main meals, twenty-one times within two weeks before delivery |
| maternal HbA1c at the term | percent [%] | glycated haemoglobin measured within a month before delivery |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |