Clinical trial
The Influence of Advanced Age, Obesity and Diabetes Type on Course and Outcome of Pregnancy With Diabetes Mellitus.
Opening soon · Not applicable · 0 countries · Registry ID NCT04833062
What this study is 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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
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.
Primary outcomes
Mid-trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\].
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 will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\].
Third trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\].
The third trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\]
The third trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\]
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.
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.
Study locations
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