Clinical trial NCT04833062: The Influence of Advanced Age, Obesity and Diabetes Type on Course and Outcome of Pregnancy With Diabetes Mellitus.
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
Collaborators: name: City Hospital #2, Nur-Sultan, Kazakhstan
First posted: 2021-04-06
Enrollment: 4600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mid-trimester ultrasound scan: Foetal biometry
timeFrame: At 20 gestational weeks
measure: Mid-trimester ultrasound scan: uterine artery blood flow
timeFrame: At 20 gestational weeks
measure: Third trimester ultrasound scan: foetal biometry
timeFrame: At 30 weeks of gestation
measure: Third trimester ultrasound scan: foetal biometry
timeFrame: At 34 weeks of gestation
measure: Third trimester ultrasound scan: uterine artery blood flow
timeFrame: At 30 weeks of gestation
measure: Third trimester ultrasound scan: uterine artery blood flow
timeFrame: At 34 weeks of gestation
measure: Third trimester ultrasound scan: cerebro-placental ratio (CPR)
timeFrame: At 30 weeks of gestation
measure: Third trimester ultrasound scan: cerebro-placental ratio (CPR)
timeFrame: At 34 weeks of gestation
measure: Addition of the UAPI to the CPR
timeFrame: At 30 weeks of gestation
measure: Addition of the UAPI to the CPR
timeFrame: At 34 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nazarbayev University Medical Center
name: Gauri Bapayeva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: