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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: Ultrasound; Other: Survey

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.

• Study Type: Observational
• Enrollment (Anticipated): 4600

Contacts and Locations

• Study Contact: Name: Gauri Bapayeva, MD, PhD; Phone Number: +77017462800; Email: gauri.bapaeva@umc.org.kz
• Study Contact Backup: Name: Milan Terzic, MD, MsC, PhD; Email: milan.terzic@nu.edu.kz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study will include all pregnant women with diabetes mellitus (DM) that will be followed-up and delivered in our clinics for seven years (from January 1st, 2022 to December 31st, 2028). The data will be prospectively collected and electronically stored at each prenatal visit and each event.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetes mellitus group; Based on DM type, all women will be divided into four groups: prepregnancy/preexisting DM insulin-dependent or independent (types I and II; classes B, C, and D) and gestational DM (GDM) with or without the need for insulin therapy (DM classes A1 and A2). In the case of gestational DM, the gestational week at the time of diagnosis will be registered. We will consider whether women are diagnosed with another preexisting disease (endocrinological or another one) before or during pregnancy, in order to check the relationship of this disease and their DM and potential risks for pregnancy.	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.
Nondiabetic group; Nondiabetic women who received birth assistance at our referral centers and who agreed to participate in the study were included in the control group. A control of healthy (non-diabetic women) mothers so to compare characteristics and outcomes across diabetic groups will comprise the control group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Nazarbayev University Medical Center
• Collaborators: City Hospital #2, Nur-Sultan, Kazakhstan
• Investigators: Principal Investigator: Gauri Bapayeva, MD, PhD, Nazarbayev University Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2028
• Study Completion (ANTICIPATED): December 31, 2029

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (ACTUAL): April 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 001-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No