Diabetes Mellitus
Conditions
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.
Interventions
DIAGNOSTIC_TESTUltrasound
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.
OTHERSurvey
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.
Sponsors
City Hospital #2, Nur-Sultan, Kazakhstan
Nazarbayev University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mid-trimester ultrasound scan: Foetal biometry | At 20 gestational weeks | Mid-trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\]. |
| Mid-trimester ultrasound scan: uterine artery blood flow | At 20 gestational weeks | Mid-trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\] |
| Third trimester ultrasound scan: foetal biometry | At 30 weeks of gestation | Third trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\]. |
| Third trimester ultrasound scan: uterine artery blood flow | At 30 weeks of gestation | The third trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\] |
| Third trimester ultrasound scan: cerebro-placental ratio (CPR) | At 30 weeks of gestation | 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. |
| Addition of the UAPI to the CPR | At 30 weeks of gestation | 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. |
Contacts
Primary ContactGauri Bapayeva, MD, PhD
Backup ContactMilan Terzic, MD, MsC, PhD
Outcome results
None listed