Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833062
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-04-06
First Post:
2021-03-31
Brief Title:
The Influence of Advanced Age Obesity and Diabetes Type on Course and Outcome of Pregnancy With Diabetes Mellitus
Sponsor:
Nazarbayev University Medical Center
Organization:
Nazarbayev University
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None