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

Nazarbayev University Medical Center

Status: Not yet enrolling

Conditions: Diabetes Mellitus

Treatments: Other: Survey; Diagnostic Test: Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT04833062

001-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

4,600 participants in 2 patient groups

Diabetes mellitus group

Description:

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.

Treatment:

Other: Survey

Diagnostic Test: Ultrasound

Nondiabetic group

Description:

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.

Treatment:

Other: Survey

Diagnostic Test: Ultrasound