跳至主要内容
临床试验/NCT04833062
NCT04833062尚未招募不适用

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.

Nazarbayev University Medical Center0 个研究点目标入组 4,600 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
4,600
主要终点
Mid-trimester ultrasound scan: Foetal biometry

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All pregnant women with diabetes mellitus (18 yo and older).

排除标准

  • Cases of multiple pregnancies
  • Cases of long-term use of corticosteroids
  • Cases complicated by congenital fetal abnormalities or aneuploidy.

结局指标

主要结局

Mid-trimester ultrasound scan: Foetal biometry

时间窗: At 20 gestational weeks

Mid-trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\].

Third trimester ultrasound scan: foetal biometry

时间窗: At 34 weeks of gestation

Third trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\].

Mid-trimester ultrasound scan: uterine artery blood flow

时间窗: At 20 gestational weeks

Mid-trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\]

Third trimester ultrasound scan: uterine artery blood flow

时间窗: At 34 weeks of gestation

The third trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\]

Third trimester ultrasound scan: cerebro-placental ratio (CPR)

时间窗: At 34 weeks of gestation

This third trimester ultrasound will assess the relationship between the cerebro-placental ratio (CPR) and intrapartum and perinatal outcomes in pregnancies complicated by different types of Diabetes mellitus and to determine if the CPR measured at 30 and 34 weeks of gestation is predictive of adverse obstetric and perinatal outcomes.

Addition of the UAPI to the CPR

时间窗: At 34 weeks of gestation

The third trimester ultrasound will assess whether the addition of the UAPI to the CPR, alone or as CPUR \[cerebro-placental-uterine ratio (CPUR)\], improves the ability of CPR to predict APO at the end of pregnancy in any subgroup of diabetic patients.

次要结局

未报告次要终点

研究者

发起方
Nazarbayev University Medical Center
申办方类型
Other
责任方
Sponsor

相似试验