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| ID | Type | Description | Link |
|---|---|---|---|
| 23-CRFG-21 | Other Identifier | Clinical Research Facility Galway (CRFG) study number |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention as the study is observational. | Other | No intervention as the study is observational. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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)
| 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. | 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female participants only
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Galway | Galway | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42010697 | Derived | 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. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Lipid levels will be assessed by measuring a fasting sample and will be analysed using local assays. |
| 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. | Up to 10 years post the index pregnancy |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |