Studies

Observational Not yet recruiting

NCT04833062 on ClinicalTrials.gov

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.

  • Sponsor: Nazarbayev University
  • Collaborators: City Hospital #2, Nur-Sultan, Kazakhstan
  • Enrollment: 4600 (Estimated)
  • Study start: 2022-01-01 (Estimated)
  • Primary completion: 2028-12-31 (Estimated)
  • Study completion: 2029-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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.

Conditions

  • Diabetes Mellitus

Intervention / Treatment

  • Diagnostic Test: Ultrasound
  • Other: Survey

Primary Outcome Measures

  • 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: foetal biometry (At 34 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: uterine artery blood flow (At 34 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.
  • Third trimester ultrasound scan: cerebro-placental ratio (CPR) (At 34 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.
  • Addition of the UAPI to the CPR (At 34 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.

Study Officials