Gestational DiabetesNCT06327191
EMERGE Mothers and Kids
An observational study of Gestational Diabetes, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes
- How many people
- 370 participants
- Where
- 1 siteIreland
- Study dates
- 9 Jul 2024to 2 Apr 2026
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The population for this longitudinal cohort study is women who participated in the EMERGE randomised controlled trial and who consented to be contacted about further follow-up studies.
Who may be able to join
- Participation in the original EMERGE trial and consenting to further follow up.
Who cannot join
- EMERGE trial participants who did not provide consent for further follow up studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EMERGE Mothers and Kids: a Longitudinal Cohort Study of Mothers and Kids Enrolled in the Randomized Placebo Controlled Trial of Metformin in Women With GDM (EMERGE)
The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality.
The primary objectives of the EMERGE Mothers and Kids follow up study are:
- to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 10 years post the index pregnancy;
- to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;
- to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;
- to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.
- Conditions
- Gestational Diabetes
- Being tested
- No intervention as the study is observational.
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention as the study is observational.Other
No intervention as the study is observational.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up..
This will be evaluated using a 75g oral glucose tolerance test (OGTT) and a haemoglobin A1c (HbA1c). Cutoffs for diabetes, imparied fasting gluocse and impaired glucose tolerance will be in line with the American Diabetes Association diagnostic criteria (ADA 2023).
Measured: Up to 10 years post the index pregnancy
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome.
Metabolic syndrome is defined as the presence of >3 of the following risk factors (International Diabetetes Foundation 2009)
- Fasting glucose >5.6 mmol/L or diagnosed diabetes
- High density lipoprotein (HDL) cholesterol of <1.3 mmol/L or drug treatment for low HDL cholesterol
- Triglyceride level of >1.7 mmol/L or drug treatment for elevated triglycerides
- Waist circumference of >80cm
- Hypertension with a blood pressure of > 130/85 mmHg or drug treatment for hypertension
Measured: Up to 10 years post the index pregnancy
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up.
Definitions of overweight and obesity are a body mass index of >25 kg/m2 and >30 kg/m2, respectively.
Measured: Up to 10 years post the index pregnancy
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension.
Hypertension is defined as a blood pressure of > 130 mmHg systolic or >80 mmHg diatolic (Whelton 2017).
Measured: Up to 10 years post the index pregnancy
To examine the associations of GDM diagnosis, sum of fasting, 1-hour, and 2-hour glucose z-scores after 75-g load, insulin sensitivity, and lipid levels at 24-32 weeks' gestation with lipid levels at up to 10 years postpartum.
Lipid levels will be assessed by measuring a fasting sample and will be analysed using local assays.
Measured: Up to 10 years post the index pregnancy
To determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.
Obesity will be defined as a BMI of >95th percentile or BMI > 30 kg/m2 (whichever is lower) for children 2 years and older. Overweight will be defined as a BMI of >85th percentile.
Weight for height gender specific growth charts will be used for children <2 years of age and a weight-for-height which is >95th centile will be considered obese. Overweight wil be defined as a BMI of >85th percentile.
Measured: Up to 10 years post the index pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start9 Jul 2024
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- Cross-sectional
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fidelma Dunne, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327191
- Sponsor's protocol ID
- 23-CRFG-21
- Other IDs
- 23-CRFG-21
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scairati R, Newman C, Alvarez-Iglesias A, Smyth A, O'Shea PM, Devane D, Gillespie P, Egan AM, O'Donnell M, Dunne FP. EMERGE Mothers and Kids: a longitudinal cohort study of mothers and children enrolled in the randomized placebo-controlled trial of metformin in women with GDM (EMERGE): study protocol. Trials. 2026 Apr 20;27(1):405. doi: 10.1186/s13063-026-09703-6.
PubMed 42010697
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMERGE Mothers and Kids: a Longitudinal Cohort Study of Mothers and Kids Enrolled in the Randomized Placebo Controlled Trial of Metformin in Women With GDM (EMERGE)
- ClinicalTrials.gov ID
- NCT06327191
- Acronym / sponsor ID
- 23-CRFG-21
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 25 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 EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality.
The primary objectives of the EMERGE Mothers and Kids follow up study are:
- to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 10 years post the index pregnancy;
- to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;
- to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;
- to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population for this longitudinal cohort study is women who participated in the EMERGE randomised controlled trial and who consented to be contacted about further follow-up studies.
Key inclusion criteria (1 listed)
- Participation in the original EMERGE trial and consenting to further follow up.
Key exclusion criteria (1 listed)
- EMERGE trial participants who did not provide consent for further follow up studies.
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 |
|---|---|---|
| No intervention as the study is observational.No intervention as the study is observational. | Other | – |
Primary outcome
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up..
Time frame: Up to 10 years post the index pregnancy
This will be evaluated using a 75g oral glucose tolerance test (OGTT) and a haemoglobin A1c (HbA1c). Cutoffs for diabetes, imparied fasting gluocse and impaired glucose tolerance will be in line with the American Diabetes Association diagnostic criteria (ADA 2023).
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome.
Time frame: Up to 10 years post the index pregnancy
Metabolic syndrome is defined as the presence of >3 of the following risk factors (International Diabetetes Foundation 2009) * Fasting glucose >5.6 mmol/L or diagnosed diabetes * High density lipoprotein (HDL) cholesterol of <1.3 mmol/L or drug treatment for low HDL cholesterol * Triglyceride level of >1.7 mmol/L or drug treatment for elevated triglycerides * Waist circumference of >80cm * Hypertension with a blood pressure of > 130/85 mmHg or drug treatment for hypertension
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up.
Time frame: Up to 10 years post the index pregnancy
Definitions of overweight and obesity are a body mass index of >25 kg/m2 and >30 kg/m2, respectively.
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension.
Time frame: Up to 10 years post the index pregnancy
Hypertension is defined as a blood pressure of > 130 mmHg systolic or >80 mmHg diatolic (Whelton 2017).
To examine the associations of GDM diagnosis, sum of fasting, 1-hour, and 2-hour glucose z-scores after 75-g load, insulin sensitivity, and lipid levels at 24-32 weeks' gestation with lipid levels at up to 10 years postpartum.
Time frame: Up to 10 years post the index pregnancy
Lipid levels will be assessed by measuring a fasting sample and will be analysed using local assays.
To determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.
Time frame: Up to 10 years post the index pregnancy
Obesity will be defined as a BMI of >95th percentile or BMI > 30 kg/m2 (whichever is lower) for children 2 years and older. Overweight will be defined as a BMI of >85th percentile. Weight for height gender specific growth charts will be used for children <2 years of age and a weight-for-height which is >95th centile will be considered obese. Overweight wil be defined as a BMI of >85th percentile.
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 15 Jun 2026.
- Derived from this study: PubMed 42010697Scairati R, Newman C, Alvarez-Iglesias A, Smyth A, O'Shea PM, Devane D, Gillespie P, Egan AM, O'Donnell M, Dunne FP. EMERGE Mothers and Kids: a longitudinal cohort study of mothers and children enrolled in the randomized placebo-controlled trial of metformin in women with GDM (EMERGE): study protocol. Trials. 2026 Apr 20;27(1):405. doi: 10.1186/s13063-026-09703-6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gestational Diabetes, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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 1 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 15 Jun 2026. 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 Ireland. 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?
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up.. (time frame: Up to 10 years post the index pregnancy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327191, which also lists 1 linked publication.
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 15 Jun 2026.