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

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ClinicalTrials.gov Identifier: NCT04833062
Recruitment Status : Not yet recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Collaborator:
City Hospital #2, Nur-Sultan, Kazakhstan
Information provided by (Responsible Party):
Nazarbayev University ( Nazarbayev University Medical Center )

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Diabetes Mellitus Diagnostic Test: Ultrasound Other: Survey

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 4600 participants
Observational Model: Case-Control
Time Perspective: Prospective
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.
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.

Other: 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.
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
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.

Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Mid-trimester ultrasound scan: Foetal biometry [ Time Frame: At 20 gestational weeks ]
    Mid-trimester ultrasound scan will assess foetal biometry [abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)].

  2. Mid-trimester ultrasound scan: uterine artery blood flow [ Time Frame: 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)]

  3. Third trimester ultrasound scan: foetal biometry [ Time Frame: At 30 weeks of gestation ]
    Third trimester ultrasound scan will assess foetal biometry [abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)].

  4. Third trimester ultrasound scan: foetal biometry [ Time Frame: At 34 weeks of gestation ]
    Third trimester ultrasound scan will assess foetal biometry [abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)].

  5. Third trimester ultrasound scan: uterine artery blood flow [ Time Frame: 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)]

  6. Third trimester ultrasound scan: uterine artery blood flow [ Time Frame: 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)]

  7. Third trimester ultrasound scan: cerebro-placental ratio (CPR) [ Time Frame: 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.

  8. Third trimester ultrasound scan: cerebro-placental ratio (CPR) [ Time Frame: 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.

  9. Addition of the UAPI to the CPR [ Time Frame: 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.

  10. Addition of the UAPI to the CPR [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833062


Contacts
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Contact: Gauri Bapayeva, MD, PhD +77017462800 gauri.bapaeva@umc.org.kz
Contact: Milan Terzic, MD, MsC, PhD milan.terzic@nu.edu.kz

Sponsors and Collaborators
Nazarbayev University Medical Center
City Hospital #2, Nur-Sultan, Kazakhstan
Investigators
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Principal Investigator: Gauri Bapayeva, MD, PhD Nazarbayev University Medical Center
More Information
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Responsible Party: Nazarbayev University Medical Center
ClinicalTrials.gov Identifier: NCT04833062    
Other Study ID Numbers: 001-2021
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases