The Influence of Advanced Age, Obesity and Diabetes Type on Course and Outcome of Pregnancy With Diabetes Mellitus.

Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04833062
• Other study ID #: 001-2021
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2021
• Source: Nazarbayev University Medical Center
• Contact: Gauri Bapayeva, MD, PhD
• Phone: +77017462800
• Email: gauri.bapaeva[@]umc.org.kz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4600
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Cases of multiple pregnancies

• Cases of long-term use of corticosteroids

• Cases complicated by congenital fetal abnormalities or aneuploidy.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Diagnostic Test:
• 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.

Other:
• 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 classified according to the prepregnancy BMI.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nazarbayev University Medical Center	City Hospital #2, Nur-Sultan, Kazakhstan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mid-trimester ultrasound scan: Foetal biometry	Mid-trimester ultrasound scan will assess foetal biometry [abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)].	At 20 gestational weeks
Primary	Mid-trimester ultrasound scan: uterine artery blood flow	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)]	At 20 gestational weeks
Primary	Third trimester ultrasound scan: foetal biometry	Third trimester ultrasound scan will assess foetal biometry [abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)].	At 30 weeks of gestation
Primary	Third trimester ultrasound scan: foetal biometry	Third trimester ultrasound scan will assess foetal biometry [abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)].	At 34 weeks of gestation
Primary	Third trimester ultrasound scan: uterine artery blood flow	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)]	At 30 weeks of gestation
Primary	Third trimester ultrasound scan: uterine artery blood flow	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)]	At 34 weeks of gestation
Primary	Third trimester ultrasound scan: cerebro-placental ratio (CPR)	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.	At 30 weeks of gestation
Primary	Third trimester ultrasound scan: cerebro-placental ratio (CPR)	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.	At 34 weeks of gestation
Primary	Addition of the UAPI to the CPR	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.	At 30 weeks of gestation
Primary	Addition of the UAPI to the CPR	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.	At 34 weeks of gestation