The Influence of Advanced Age, Obesity and Diabetes Type on Course and Outcome of Pregnancy With Diabetes Mellitus.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Ultrasound, Survey.
- Кому может быть актуально
- Состояния в реестре: Diabetes Mellitus. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Influence of Advanced Age, Obesity and Diabetes Type on Course and Outcome of Pregnancy With Diabetes Mellitus: Predictive Role of Clinical, Sonographic and Laboratory Findings.
Обзор
Results of this project will enable investigators to get information and to compare maternal and pregnancy characteristics and perinatal outcomes of women with different types of Diabetes Mellitus and to identify the independent risk factors for adverse perinatal outcomes. Particularly, the impact of the advanced age, obesity, and type of diabetes on the course and outcome of pregnancy will be evaluated.
Подробное описание
The prevalence of obesity and metabolic diseases (such as type 2 diabetes mellitus, dyslipidaemia, and cardiovascular diseases) has increased in recent years, in both industrialized and developing countries. Diabetes mellitus (DM) is one of the most common disorders which occurred during pregnancy. Approximately 15% of pregnancies worldwide are thought to be affected by preexisting or gestational insulin-dependent (type 1) or independent (type 2) diabetes mellitus (DM).
The utility of mid- and third trimester ultrasound parameters will be assessed for prediction of intrapartal events and perinatal outcomes in patients with diabetes mellitus. The importance of mid-trimester uterine artery blood flow and foetal biometry will be investigated for prediction of intrapartal events and perinatal outcomes in patients with diabetes mellitus. Moreover, an investigation of the utility of third trimester (measured at 30 and 34 weeks of gestation) ultrasound scan will be carried out for prediction of intrapartal events and perinatal outcomes in patients with diabetes mellitus. Additionally, researchers will assess the relationship between the cerebro-placental ratio (CPR) and intrapartum and perinatal outcomes in pregnancies complicated by different types of Diabetes mellitus to determine if the CPR measured at 30 and 34 weeks of gestation is predictive of adverse obstetric and perinatal outcomes. At the end, investigators will evaluate the role of the addition of the UAPI to the CPR, alone or as CPUR \[cerebro-placental-uterine ratio (CPUR)\], in the improvement of the ability of CPR to predict APO at the end of pregnancy in any subgroup of diabetic patients. Finally, this project will enable precise intervention and resource saving as well as provide evidence for preventable targets development.
Вмешательства
- Диагностический тест Ultrasound
In women presenting for a routine antenatal appointment at 20 gestational weeks an ultrasound assessment will be carried out using the 3.5 MHz abdominal probe in order to assess foetal biometry and anatomy as per the guidelines. We will assess the utility of mid- and third trimester ultrasound parameters for prediction of intrapartal events and perinatal outcomes in patients with diabetes mellitus. - Другое Survey
The maternal baseline characteristics are defined by maternal age at enrollment, parity, number of prenatal visits, some indicators of socioeconomic status and habits, family history of DM (first degree) and prepregnancy hypertension. The prepregnancy body mass index (BMI; kg/m2) will be calculated using the self-reported prepregnancy maternal weight; the pregnancy weight gain (kg) will be calculated by the difference between final pregnancy weight and prepregnancy maternal weight and was class
Первичные конечные точки
- Mid-trimester ultrasound scan: Foetal biometry [Срок оценки: At 20 gestational weeks]
- Mid-trimester ultrasound scan: uterine artery blood flow [Срок оценки: At 20 gestational weeks]
- Third trimester ultrasound scan: foetal biometry [Срок оценки: At 30 weeks of gestation]
- Third trimester ultrasound scan: foetal biometry [Срок оценки: At 34 weeks of gestation]
- Third trimester ultrasound scan: uterine artery blood flow [Срок оценки: At 30 weeks of gestation]
- Third trimester ultrasound scan: uterine artery blood flow [Срок оценки: At 34 weeks of gestation]
- Third trimester ultrasound scan: cerebro-placental ratio (CPR) [Срок оценки: At 30 weeks of gestation]
- Third trimester ultrasound scan: cerebro-placental ratio (CPR) [Срок оценки: At 34 weeks of gestation]
- Addition of the UAPI to the CPR [Срок оценки: At 30 weeks of gestation]
- Addition of the UAPI to the CPR [Срок оценки: At 34 weeks of gestation]
Критерии участия
Критерии включения
- All pregnant women with diabetes mellitus (18 yo and older).
Критерии исключения
- Cases of multiple pregnancies
- Cases of long-term use of corticosteroids
- Cases complicated by congenital fetal abnormalities or aneuploidy.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT04833062 · 001-2021