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

NCT04833062 | Not Yet Recruiting

• 1 other identifier: 001-2021
• Study Type: observational
• Target: 4,600
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (10)

• Mid-trimester ultrasound scan: Foetal biometry

  Mid-trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\].

  At 20 gestational weeks

• Mid-trimester ultrasound scan: uterine artery blood flow

  Mid-trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\]

  At 20 gestational weeks

• Third trimester ultrasound scan: foetal biometry

  Third trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\].

  At 30 weeks of gestation

• Third trimester ultrasound scan: foetal biometry

  Third trimester ultrasound scan will assess foetal biometry \[abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)\].

  At 34 weeks of gestation

• Third trimester ultrasound scan: uterine artery blood flow

  The third trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\]

  At 30 weeks of gestation

• Third trimester ultrasound scan: uterine artery blood flow

  The third trimester ultrasound scan will assess uterine artery blood flow \[early-diastolic uterine artery blood flow waveform notching, as well as the uterine artery pulsatility index (UAPI)\]

  At 34 weeks of gestation

• Third trimester ultrasound scan: cerebro-placental ratio (CPR)

  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.

  At 30 weeks of gestation

• Third trimester ultrasound scan: cerebro-placental ratio (CPR)

  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.

  At 34 weeks of gestation

• Addition of the UAPI to the CPR

  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.

  At 30 weeks of gestation

• Addition of the UAPI to the CPR

  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.

  At 34 weeks of gestation

Study Arms (2)

Diabetes mellitus group

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.

Diagnostic Test: Ultrasound; Other: Survey

Nondiabetic group

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.

Diagnostic Test: Ultrasound; Other: Survey

Interventions

Ultrasound DIAGNOSTIC_TEST

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.

Diabetes mellitus group; Nondiabetic group

Survey OTHER

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.

Diabetes mellitus group; Nondiabetic group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All pregnant women with diabetes mellitus (18 yo and older).

You may not qualify if:

• Cases of multiple pregnancies
• Cases of long-term use of corticosteroids
• Cases complicated by congenital fetal abnormalities or aneuploidy.

Sponsors & Collaborators

• Nazarbayev University Medical Center: lead
• City Hospital #2, Nur-Sultan, Kazakhstan: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Ultrasonography; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gauri Bapayeva, MD, PhD

  Nazarbayev University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gauri Bapayeva, MD, PhD

CONTACT

+77017462800; gauri.bapaeva@umc.org.kz

Milan Terzic, MD, MsC, PhD

CONTACT

milan.terzic@nu.edu.kz

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 6, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share