Diabetes MellitusNCT04833062
The Influence of Advanced Age, Obesity and Diabetes Type on Course and Outcome of Pregnancy With Diabetes Mellitus.
An observational study of Diabetes Mellitus, run by Nazarbayev University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Ultrasound and Survey
- How many people
- 4,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- All pregnant women with diabetes mellitus (18 yo and older).
Who cannot join
- Cases of multiple pregnancies
- Cases of long-term use of corticosteroids
- Cases complicated by congenital fetal abnormalities or aneuploidy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Milan Terzic, MD, MsC, PhD contact
About this study
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.
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Ultrasound, Survey
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic 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.
SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Ultrasound; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid-trimester ultrasound scan: Foetal biometry
Mid-trimester ultrasound scan will assess foetal biometry [abdominal circumference (AC), femoral length (FL), biparietal dimension (BPD)].
Measured: 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)]
Measured: 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)].
Measured: 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)].
Measured: 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)]
Measured: 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)]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 34 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- City Hospital #2, Nur-Sultan, Kazakhstan
- Responsible party
- Sponsor
- Investigators
- Gauri Bapayeva, MD, PhD, Principal investigator, Nazarbayev University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833062
- Sponsor's protocol ID
- 001-2021
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04833062
- Acronym / sponsor ID
- 001-2021
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,600 participants (estimated)
- Lead sponsor
- Nazarbayev University Medical CenterUniversity, hospital or other
- Collaborators
- City Hospital #2, Nur-Sultan, Kazakhstan
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus group | – | Diagnostic Test: Ultrasound, Other: SurveyBased 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. |
| Nondiabetic group | – | Diagnostic Test: Ultrasound, Other: SurveyNondiabetic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All pregnant women with diabetes mellitus (18 yo and older).
Key exclusion criteria (3 listed)
- Cases of multiple pregnancies
- Cases of long-term use of corticosteroids
- Cases complicated by congenital fetal abnormalities or aneuploidy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundIn 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. | Diagnostic test | Diabetes mellitus group, Nondiabetic group |
| SurveyThe 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. | Other | Diabetes mellitus group, Nondiabetic group |
Primary outcome
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)].
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)]
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)].
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)].
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)]
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)]
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milan Terzic, MD, MsC, PhD contact
Gauri Bapayeva, MD, PhD principal investigator
Nazarbayev University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Nazarbayev University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gauri Bapayeva, MD, PhD (+77017462800, gauri.bapaeva@umc.org.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid-trimester ultrasound scan: Foetal biometry (time frame: At 20 gestational weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.