Pregnancy RelatedMoMM-FETNCT06288126
Maternal and Fetal Metabolic Changes
An observational study of Pregnancy Related and Maternal-Fetal Relations, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Maternal-Fetal Relations, Metabolism Disorder, Glucose
- How many people
- 457 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2019to 18 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with a singleton pregnancy attending our Centre for aneuploidies screening in the first trimester.
Who may be able to join
- singleton pregnancy
- first visit between 11 and 14 weeks of pregnancy
Who cannot join
- consent withdrawal
- multiple pregnancy
- prepregnancy diabetes mellitus
- women undergoing therapy with oral hypoglycaemic drugs
- previous bariatric surgery
- fetal chromosomal and/or major structural abnormalities were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical and Ecographic Risk Markers in Pregnancies at High and Low Risk for the Development of Glycemic and Metabolic Complications in Pregnancy
The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring.
Primary objectives:
Read more
- measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM
- ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits.
- Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia.
Secondary objectives:
- Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women.
- Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit).
The participants will be recruited during first trimester ultrasound after signing the informed consent.
Read the detailed description
Pregnancy has been defined "a stress test for life". During pregnancy, even if uncomplicated, women experience metabolic and cardiovascular changes that predispose to vascular endothelial dysfunction. Women who are already predisposed to this phenotype develop gestational hypertension or gestational diabetes (GDM), which can re-emerge later in life. This has been demonstrated by several studies in which the presence of pregnancy diseases (GDM, maternal preeclampsia and fetal growth disorder) correlate with the development of chronic disorders, such as chronic hypertension, diabetes mellitus and metabolic syndrome, suggesting a common pathogenic pathway. From this point of view, pregnancy constitutes a unique period to evaluate metabolic and cardiovascular markers, to better understand the pathogenesis of these disorders and possibly obtain preventive strategies. The identification of early biomarkers of metabolic dysfunction would be particularly useful in overweight and obese pregnant women. There is a growing prevalence of obesity worldwide; in developed Countries, 40-50% of the pregnant population is overweight and obese, which is, according to a recent report from the United Kingdom, the main contributing cause of death during gestation.
In addition, obesity and maternal hyperglycaemia during pregnancy may induce intrauterine overnutrition and fetal hyperinsulinemia, resulting in excessive fetal growth. Fetal macrosomia is associated with an increased risk of perinatal morbidity and mortality. Large babies have increased risk of intrapartum complications such as prolonged labour and shoulder dystocia. Moreover, the environmental and metabolic characteristics of intrauterine life deeply influence the individual in the long-term as a child and through adulthood, with possible adverse metabolic consequences, including predisposition to insulin resistance and obesity.
The evaluation of fetal tissue distribution and the recently introduced study of the fetal liver volume constitute very interesting markers of fetal adiposity and could be used as early indicators of insulin resistance in newborns.
The participants will be recruited during first trimester ultrasound after signing the informed consent. At 11-13 weeks:
- Ultrasound evaluation of fetal biometry and amniotic fluid will be performed. Periodic maternal anthropometric evaluation (weight gain and body mass index (BMI), blood pressure). Women will be divided in lean, overweight and obese.
- Blood sample for inflammatory cytokines will be taken.
- Maternal body composition evaluation through bioimpedance and/or highly reliable ultrasound-based analysis of ectopic fat. This approach is ideal to provide biomarkers of insulin resistance. In brief, women will be evaluated by a standardized set of US clips for the assessment of liver fat, cardiac fat, abdominal subcutaneous and visceral fat.
At 16-18 weeks: standard screening for gestational diabetes for high risk women, as for clinical practice
At 24-28 weeks:
- Standard screening for gestational diabetes to all women
- Fetal ultrasound to study fetal liver volume and/or subcutaneous fat tissue quantification. These constitute innovative techniques to obtain an early identification of macrosomic fetuses.
At delivery:
- Information on mode of delivery and any complications
- Within 48 hours of birth, anthropometric assessment of the infant according to clinical practice (weight, abdominal and head circumference).
- Keywords
- metabolism, insulin resistance, adipose tissue, insulin-signalling pathway
- Medical subject headings
- Glucose Metabolism Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High Risk Group | This group include women at high risk for gestational diabetes (GDM) according to most of the European guidelines. They have one or more of the following criteria: age ≥35 years, overweight or obesity, family history of diabetes, high-risk ethnicities, history of previous GDM or previous macrosomia, and high levels of fasting glycemia during the first trimester screening. | |
| Low Risk Group | This group will include women at low risk for GDM according to most of the European guidelines. They have none of the following criteria: age ≥35 years, overweight or obesity, family history of diabetes, high-risk ethnicities, history of previous GDM or previous macrosomia, and high levels of fasting glycemia during the first trimester screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood adipokine levels
Adiponectine (ug/mL); insulin (ng/mL); C-peptide (ng/mL); leptin (ng/mL); resistin (ng/mL)
Measured: Between 11 (+0 days) and 13 (+6 days) weeks of pregnancy (recruitment visit)
Abdominal Fat Thickness
Ultrasound evaluation, measures expressed in mm. Abdominal Subcutaneous Fat Thickness (ASFT): lower ASFT (thickness of ASFT at the intersection of the horizontal line between the highest points of the iliac crest and the alba line, measuring the thickness of the external face of the rectus abdominis muscle at the skin's surface, with the minimum possible pressure applied on the skin); upper ASFT (subcutaneous adipose thickness at the maximum vertical distance from the skin line to the anterior edge of the linea alba, after a mid-sagittal section of the upper maternal abdomen, with the minimum possible pressure from the probe).
Visceral Abdominal Fat Thickness (VAT): adipose tissue in the anterior abdomen at the xipho-umbilical line.
Measured: Between 11 (+0 days) and 13 (+6 days) weeks of pregnancy (recruitment visit)
Fetal Adipose Tissue Deposits
Ultrasound evaluation, measures expressed in mm. Thickness of subcutaneous adipose tissue in the abdomen, thigh, arm.
Measured: Between 28 (+0 days) and 40 (+6 days) weeks of pregnancy (third trimester control visit)
Secondary outcomes (2)
Gestational diabetes prevalence
Prevalence of gestational diabetes according to the class of risk (high or low risk)
Measured: Between 14 (+0 days) and 27 (+6 days) weeks of pregnancy (second trimester control visit) and third trimester control visit
Obstetric complications and mode of delivery
Occurrence of gestational hypertension, pre-eclampsia, intrauterine growth restriction, preterm labour. Mode of delivery (spontaneous, cesarean section, operative).
Measured: Recruitment visit; second trimester control visit; third trimester control visit; in the day of the delivery, in average 6 months after recruitment visit (post-partum visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Aug 2019
- Primary completion9 Oct 2020
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Simoncini, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Tommaso Simoncini, MD. PhD., Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288126
- Sponsor's protocol ID
- MoMM-FET
- Acronym
- MoMM-FET
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 1 Mar 2024
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Ecographic Risk Markers in Pregnancies at High and Low Risk for the Development of Glycemic and Metabolic Complications in Pregnancy
- ClinicalTrials.gov ID
- NCT06288126
- Acronym / sponsor ID
- MoMM-FET / MoMM-FET
- Keywords
- metabolism, insulin resistance, adipose tissue, insulin-signalling pathway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 1 Mar 2024 (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.
The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring.
Primary objectives:
- measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM
- ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits.
- Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia.
Secondary objectives:
- Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women.
- Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit).
The participants will be recruited during first trimester ultrasound after signing the informed consent.
Detailed description
Pregnancy has been defined "a stress test for life". During pregnancy, even if uncomplicated, women experience metabolic and cardiovascular changes that predispose to vascular endothelial dysfunction. Women who are already predisposed to this phenotype develop gestational hypertension or gestational diabetes (GDM), which can re-emerge later in life. This has been demonstrated by several studies in which the presence of pregnancy diseases (GDM, maternal preeclampsia and fetal growth disorder) correlate with the development of chronic disorders, such as chronic hypertension, diabetes mellitus and metabolic syndrome, suggesting a common pathogenic pathway. From this point of view, pregnancy constitutes a unique period to evaluate metabolic and cardiovascular markers, to better understand the pathogenesis of these disorders and possibly obtain preventive strategies. The identification of early biomarkers of metabolic dysfunction would be particularly useful in overweight and obese pregnant women. There is a growing prevalence of obesity worldwide; in developed Countries, 40-50% of the pregnant population is overweight and obese, which is, according to a recent report from the United Kingdom, the main contributing cause of death during gestation.
In addition, obesity and maternal hyperglycaemia during pregnancy may induce intrauterine overnutrition and fetal hyperinsulinemia, resulting in excessive fetal growth. Fetal macrosomia is associated with an increased risk of perinatal morbidity and mortality. Large babies have increased risk of intrapartum complications such as prolonged labour and shoulder dystocia. Moreover, the environmental and metabolic characteristics of intrauterine life deeply influence the individual in the long-term as a child and through adulthood, with possible adverse metabolic consequences, including predisposition to insulin resistance and obesity.
The evaluation of fetal tissue distribution and the recently introduced study of the fetal liver volume constitute very interesting markers of fetal adiposity and could be used as early indicators of insulin resistance in newborns.
The participants will be recruited during first trimester ultrasound after signing the informed consent. At 11-13 weeks:
- Ultrasound evaluation of fetal biometry and amniotic fluid will be performed. Periodic maternal anthropometric evaluation (weight gain and body mass index (BMI), blood pressure). Women will be divided in lean, overweight and obese.
- Blood sample for inflammatory cytokines will be taken.
- Maternal body composition evaluation through bioimpedance and/or highly reliable ultrasound-based analysis of ectopic fat. This approach is ideal to provide biomarkers of insulin resistance. In brief, women will be evaluated by a standardized set of US clips for the assessment of liver fat, cardiac fat, abdominal subcutaneous and visceral fat.
At 16-18 weeks: standard screening for gestational diabetes for high risk women, as for clinical practice
At 24-28 weeks:
- Standard screening for gestational diabetes to all women
- Fetal ultrasound to study fetal liver volume and/or subcutaneous fat tissue quantification. These constitute innovative techniques to obtain an early identification of macrosomic fetuses.
At delivery:
- Information on mode of delivery and any complications
- Within 48 hours of birth, anthropometric assessment of the infant according to clinical practice (weight, abdominal and head circumference).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Group | – | –This group include women at high risk for gestational diabetes (GDM) according to most of the European guidelines. They have one or more of the following criteria: age ≥35 years, overweight or obesity, family history of diabetes, high-risk ethnicities, history of previous GDM or previous macrosomia, and high levels of fasting glycemia during the first trimester screening. |
| Low Risk Group | – | –This group will include women at low risk for GDM according to most of the European guidelines. They have none of the following criteria: age ≥35 years, overweight or obesity, family history of diabetes, high-risk ethnicities, history of previous GDM or previous macrosomia, and high levels of fasting glycemia during the first trimester screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a singleton pregnancy attending our Centre for aneuploidies screening in the first trimester.
Key inclusion criteria (2 listed)
- singleton pregnancy
- first visit between 11 and 14 weeks of pregnancy
Key exclusion criteria (6 listed)
- consent withdrawal
- multiple pregnancy
- prepregnancy diabetes mellitus
- women undergoing therapy with oral hypoglycaemic drugs
- previous bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood adipokine levels
Time frame: Between 11 (+0 days) and 13 (+6 days) weeks of pregnancy (recruitment visit)
Adiponectine (ug/mL); insulin (ng/mL); C-peptide (ng/mL); leptin (ng/mL); resistin (ng/mL)
Abdominal Fat Thickness
Time frame: Between 11 (+0 days) and 13 (+6 days) weeks of pregnancy (recruitment visit)
Ultrasound evaluation, measures expressed in mm. Abdominal Subcutaneous Fat Thickness (ASFT): lower ASFT (thickness of ASFT at the intersection of the horizontal line between the highest points of the iliac crest and the alba line, measuring the thickness of the external face of the rectus abdominis muscle at the skin's surface, with the minimum possible pressure applied on the skin); upper ASFT (subcutaneous adipose thickness at the maximum vertical distance from the skin line to the anterior edge of the linea alba, after a mid-sagittal section of the upper maternal abdomen, with the minimum possible pressure from the probe). Visceral Abdominal Fat Thickness (VAT): adipose tissue in the anterior abdomen at the xipho-umbilical line.
Fetal Adipose Tissue Deposits
Time frame: Between 28 (+0 days) and 40 (+6 days) weeks of pregnancy (third trimester control visit)
Ultrasound evaluation, measures expressed in mm. Thickness of subcutaneous adipose tissue in the abdomen, thigh, arm.
2 secondary outcomes
Gestational diabetes prevalence
Time frame: Between 14 (+0 days) and 27 (+6 days) weeks of pregnancy (second trimester control visit) and third trimester control visit
Obstetric complications and mode of delivery
Time frame: Recruitment visit; second trimester control visit; third trimester control visit; in the day of the delivery, in average 6 months after recruitment visit (post-partum visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- 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. This study is not recruiting at the moment.
Tommaso Simoncini, MD. PhD. principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Maternal-Fetal Relations, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood adipokine levels (time frame: Between 11 (+0 days) and 13 (+6 days) weeks of pregnancy (recruitment visit)). The study lists 3 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 1 Mar 2024.