Pregnancy ComplicationsNCT06545227
Early Versus Late Monitoring Among Pregnant Women With a History of Gestational Diabetes
An observational study of Pregnancy Complications and Gestational Diabetes, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The goal of this study investigate if pregnant women with a history of gestational diabetes (GDM) have better pregnancy outcomes if they test their blood glucose four times a day early in the pregnancy versus having an oral glucose tolerance test later in the pregnancy at 28 weeks in their current pregnancy. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women only
- Conditions the study is for
- Pregnancy Complications, Gestational Diabetes
- What is being tested?
- continuous blood glucose monitoring in a subset of women (n=25) in the early monitoring group., Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25) and Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2023to 31 Dec 2026
- 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 17 to 45 years
- Women only
- Child, Adult
Study population: All pregnant women with a history of gestational diabetes in a previous pregnancy diagnosed by an oral glucose tolerance test.
Who may be able to join
- Age >16
- Pregnant
- Previous pregnancy with gestational diabetes diagnosed by an Oral Glucose Tolerance Test
- Singleton pregnancy
Who cannot join
- Women with the following risk factors will be excluded:
- Multiple pregnancy
- History of bariatric surgery
- Taking metformin or other oral hypoglycaemic agents
- HbA1c more than or equal to 48
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster Trust
London, SW10 9NH
Natasha Singh, MBBS FRCOG, 02033157892, n.mohammed@imperial.ac.uk
Mark Pandrich, MBBS, 02033157892, mark.pandrich@nhs.net
About this study
Official title: An Observational Nested Multicenter Cohort Study of Early Versus Late Monitoring Among Pregnant Women With a History of Gestational Diabetes
The goal of this study investigate if pregnant women with a history of gestational diabetes (GDM) have better pregnancy outcomes if they test their blood glucose four times a day early in the pregnancy versus having an oral glucose tolerance test later in the pregnancy at 28 weeks in their current pregnancy.
Population being studied:
Read more
All pregnant women who had a history of GDM in a previous pregnancy
Study groups:
- Women who are being managed in the pregnancy with early blood glucose monitoring (early monitoring group)
- Women who are being managed with an oral glucose tolerance test at 28-32 weeks (late monitoring group)
This study has two parts (i) observational and (ii) mechanistic or laboratory based.
In the observational part of the study, data will be collected as standard of care across different obstetric units and this data will be used to:
- compare the outcomes of the women such as need for labour to be induced, caesarean section rates, blood loss, need for treatment of their blood glucose with metformin or insulin, HbA1c values
- compare the outcomes of the offspring such as birth weight centiles, shoulder dystocia or birth trauma, hypoglycaemia, jaundice and if admitted to the neonatal unit.
The mechanistic or laboratory part of the study is aimed at studying how the two different treatment approaches affect:
- the metabolome of the pregnant woman - urine and blood samples collected at two time points will be used and mass spectrometry used to determine the amino acid and lipid profiles.
- the microbiome differs between both groups
- the pathways that regulate insulin in the placenta
- the ability of the cells in the umbilical cord differentiate into the different fat cells.
Read the detailed description
Gestational diabetes rates are globally increasing and it is now well known that women who had gestational diabetes have a recurrent risk ranging from 35.5% to 70% in a future pregnancy. Some of these women may have preexisting type 2 diabetes or glucose intolerance There is also now convincing evidence that the women with GDM are at increased risk of T2DM and cardiovascular disorders. GDM can also affect the health of the offspring and associated with an increased risk of future obesity, diabetes and cardiovascular disorders, possibly modulated through altered epigenetics of the fetus. The recent NICE guidance has recommended that women with a history of GDM should be offered early pregnancy glucose monitoring or testing with oral glucose tolerance test at 24-28 weeks. Gestational diabetes is associated with derangement in amino acid and lipid pathways and these changes can be demonstrated several weeks prior to the diagnosis of GDM. Similarly, both candidate gene and genome wide studies have reported that GDM exposure is associated with significant changes in the infant's or child's DNA methylation, with a recent meta-analysis of seven pregnancy cohorts identified differentially methylated regions (DMRs) associated with GDM within OR2L13 and CYP2E1. Others have also been able to demonstrate that GDM-associated methylation is associated with offspring obesity and T2DM.
There is emerging evidence that in pregnancy gestational diabetes can occur as early as the first trimester. However in clinical practice, screening and diagnosis does not occur until 28 weeks in the pregnancy, suggesting that in some cases the fetus may be exposed to undetected hyperglycaemia much earlier. There is varying practice in how a pregnant women with a history of GDM is managed in a future pregnancy. Some are offered early capillary blood glucose testing four times a day as early as 10 weeks (early monitoring), while others are offered diagnostic testing with an oral glucose tolerance test at 28 weeks (late monitoring). This study was designed to compare the pregnancy outcomes between the early and the late monitoring approaches to determine which is more effective in modulating the maternal metabolome, placental insulin signalling pathways and offspring DNA methylation. Equally important the multi-centre observational arm will allow comparison of maternal and neonatal outcomes between both groups.
- Conditions
- Pregnancy Complications, Gestational Diabetes
- Being tested
- continuous blood glucose monitoring in a subset of women (n=25) in the early monitoring group., Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25), Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25), Maternal and neonatal outcome data collection for all women in the study
- Medical subject headings
- Pregnancy Complications, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous blood glucose monitoring in a subset of women (n=25) in the early monitoring group.Device
To continuously monitor blood glucose from baseline to 28 weeks to determine if if there is hyperglycaemia in a subset of women (n=25)
Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25)Other
To study maternal metabolome
Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25)Other
To study mesenchymal stem cell differentiation, change in fetal epigenetic and placental signalling pathways.
Maternal and neonatal outcome data collection for all women in the studyOther
Data for maternal and neonatal outcomes will be collected
| Study group | Role | What they receive |
|---|---|---|
| Early monitoring group | Women who are testing blood glucose four times a day from 28 weeks. Receives: Other: Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25); Other: Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25); Other: Maternal and neonatal outcome data collection for all women in the study | |
| Late monitoring group | Women who have an oral glucose tolerance test at 28-32 weeks. Receives: Device: continuous blood glucose monitoring in a subset of women (n=25) in the early monitoring group.; Other: Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25); Other: Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25); Other: Maternal and neonatal outcome data collection for all women in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the maternal metabolome between the early monitoring group and the late monitoring group.
Mass spectrometry will be used to study and analyse roughly 200 aqueous metabolites from glycolysis, TCA cycle, amino acid metabolism, nucleotides, beta-oxidation and the pentose phosphate pathway, with quantification against stable isotope labelled standards
Measured: 12 months
Comparison of the cord blood DNA methylation between the early monitoring group and the late monitoring group
Cord blood DNA methylation will be assessed using the Methylation EPIC BeadArray (850,000 CpG sites). We will identify DMCpGs and DMRs, together with the networks and transcriptional hubs associated with GDM and the potential mediators and pathways.
Measured: 12 months
Secondary outcomes (6)
Comparison of Maternal HbA1c in first and third trimesters
Data from clinical records will be used to compare between the two groups (i) HbA1c in first and third trimesters
Measured: 12 months
Comparison of type of labour between both study groups
We will compared between both groups the rate of spontaneous labour, induced labours or caesarean section
Measured: 12 months
Comparison of requirement for drug treatment with metformin or insulin between both groups
Clinical data on treatment with insulin and/or metformin will be recorded for both cohorts and compared
Measured: 12 months
Comparison of rates of postpartum haemorrhage (>500mls blood) and third degree tears among both groups
Complications such as haemorrhage, and perineal trauma will be compared between groups
Measured: 12 months
Comparison of the composite neonatal outcome between both groups
Data from clinical records will be used to record and compare the composite neonatal outcome (stillbirth, hypoglycaemia, jaundice, admission to neonatal unit)
Measured: 12 months
Comparison of rates of shoulder dystocia between both study cohorts
Data on the number of cases of shoulder dystocia will be compared between the both study groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start20 Nov 2023
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Bold insight, DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Natasha Singh, MBBS FRCOG, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545227
- Sponsor's protocol ID
- 304605
- Status last verified
- Aug 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared but anonymised and via peer review publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Nested Multicenter Cohort Study of Early Versus Late Monitoring Among Pregnant Women With a History of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06545227
- Acronym / sponsor ID
- 304605
- Conditions
- Pregnancy Complications, Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Bold insight, DexCom, Inc.
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 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 study investigate if pregnant women with a history of gestational diabetes (GDM) have better pregnancy outcomes if they test their blood glucose four times a day early in the pregnancy versus having an oral glucose tolerance test later in the pregnancy at 28 weeks in their current pregnancy.
Population being studied:
All pregnant women who had a history of GDM in a previous pregnancy
Study groups:
- Women who are being managed in the pregnancy with early blood glucose monitoring (early monitoring group)
- Women who are being managed with an oral glucose tolerance test at 28-32 weeks (late monitoring group)
This study has two parts (i) observational and (ii) mechanistic or laboratory based.
In the observational part of the study, data will be collected as standard of care across different obstetric units and this data will be used to:
- compare the outcomes of the women such as need for labour to be induced, caesarean section rates, blood loss, need for treatment of their blood glucose with metformin or insulin, HbA1c values
- compare the outcomes of the offspring such as birth weight centiles, shoulder dystocia or birth trauma, hypoglycaemia, jaundice and if admitted to the neonatal unit.
The mechanistic or laboratory part of the study is aimed at studying how the two different treatment approaches affect:
- the metabolome of the pregnant woman - urine and blood samples collected at two time points will be used and mass spectrometry used to determine the amino acid and lipid profiles.
- the microbiome differs between both groups
- the pathways that regulate insulin in the placenta
- the ability of the cells in the umbilical cord differentiate into the different fat cells.
Detailed description
Gestational diabetes rates are globally increasing and it is now well known that women who had gestational diabetes have a recurrent risk ranging from 35.5% to 70% in a future pregnancy. Some of these women may have preexisting type 2 diabetes or glucose intolerance There is also now convincing evidence that the women with GDM are at increased risk of T2DM and cardiovascular disorders. GDM can also affect the health of the offspring and associated with an increased risk of future obesity, diabetes and cardiovascular disorders, possibly modulated through altered epigenetics of the fetus. The recent NICE guidance has recommended that women with a history of GDM should be offered early pregnancy glucose monitoring or testing with oral glucose tolerance test at 24-28 weeks. Gestational diabetes is associated with derangement in amino acid and lipid pathways and these changes can be demonstrated several weeks prior to the diagnosis of GDM. Similarly, both candidate gene and genome wide studies have reported that GDM exposure is associated with significant changes in the infant's or child's DNA methylation, with a recent meta-analysis of seven pregnancy cohorts identified differentially methylated regions (DMRs) associated with GDM within OR2L13 and CYP2E1. Others have also been able to demonstrate that GDM-associated methylation is associated with offspring obesity and T2DM.
There is emerging evidence that in pregnancy gestational diabetes can occur as early as the first trimester. However in clinical practice, screening and diagnosis does not occur until 28 weeks in the pregnancy, suggesting that in some cases the fetus may be exposed to undetected hyperglycaemia much earlier. There is varying practice in how a pregnant women with a history of GDM is managed in a future pregnancy. Some are offered early capillary blood glucose testing four times a day as early as 10 weeks (early monitoring), while others are offered diagnostic testing with an oral glucose tolerance test at 28 weeks (late monitoring). This study was designed to compare the pregnancy outcomes between the early and the late monitoring approaches to determine which is more effective in modulating the maternal metabolome, placental insulin signalling pathways and offspring DNA methylation. Equally important the multi-centre observational arm will allow comparison of maternal and neonatal outcomes between both groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early monitoring group | – | Other: Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25), Other: Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25), Other: Maternal and neonatal outcome data collection for all women in the studyWomen who are testing blood glucose four times a day from 28 weeks. |
| Late monitoring group | – | Device: continuous blood glucose monitoring in a subset of women (n=25) in the early monitoring group., Other: Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25), Other: Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25), Other: Maternal and neonatal outcome data collection for all women in the studyWomen who have an oral glucose tolerance test at 28-32 weeks. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- All pregnant women with a history of gestational diabetes in a previous pregnancy diagnosed by an oral glucose tolerance test.
Key inclusion criteria (4 listed)
- Age >16
- Pregnant
- Previous pregnancy with gestational diabetes diagnosed by an Oral Glucose Tolerance Test
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Multiple pregnancy
- History of bariatric surgery
- Taking metformin or other oral hypoglycaemic agents
- HbA1c more than or equal to 48
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 |
|---|---|---|
| continuous blood glucose monitoring in a subset of women (n=25) in the early monitoring group.To continuously monitor blood glucose from baseline to 28 weeks to determine if if there is hyperglycaemia in a subset of women (n=25) | Device | Late monitoring group |
| Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25)To study maternal metabolome | Other | Early monitoring group, Late monitoring group |
| Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25)To study mesenchymal stem cell differentiation, change in fetal epigenetic and placental signalling pathways. | Other | Early monitoring group, Late monitoring group |
| Maternal and neonatal outcome data collection for all women in the studyData for maternal and neonatal outcomes will be collected | Other | Early monitoring group, Late monitoring group |
Primary outcome
Comparison of the maternal metabolome between the early monitoring group and the late monitoring group.
Time frame: 12 months
Mass spectrometry will be used to study and analyse roughly 200 aqueous metabolites from glycolysis, TCA cycle, amino acid metabolism, nucleotides, beta-oxidation and the pentose phosphate pathway, with quantification against stable isotope labelled standards
Comparison of the cord blood DNA methylation between the early monitoring group and the late monitoring group
Time frame: 12 months
Cord blood DNA methylation will be assessed using the Methylation EPIC BeadArray (850,000 CpG sites). We will identify DMCpGs and DMRs, together with the networks and transcriptional hubs associated with GDM and the potential mediators and pathways.
6 secondary outcomes
Comparison of Maternal HbA1c in first and third trimesters
Time frame: 12 months
Comparison of type of labour between both study groups
Time frame: 12 months
Comparison of requirement for drug treatment with metformin or insulin between both groups
Time frame: 12 months
Comparison of rates of postpartum haemorrhage (>500mls blood) and third degree tears among both groups
Time frame: 12 months
Comparison of the composite neonatal outcome between both groups
Time frame: 12 months
Comparison of rates of shoulder dystocia between both study cohorts
Time frame: 12 months
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 9 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be shared but anonymised and via peer review publication
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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.
Natasha Singh, MBBS FRCOG study chair
Imperial College London
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 Complications and Gestational Diabetes, run by Imperial College London at 1 site in United Kingdom.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Aug 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 United Kingdom. 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?
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 Natasha Singh, MBBS FRCOG (02033159892, n.mohammed@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the maternal metabolome between the early monitoring group and the late monitoring group. (time frame: 12 months). The study lists 2 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 9 Aug 2024.