EMERGE Mothers and Kids
NCT06327191 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 321
Last updated 2024-07-19
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.
The primary objectives of the EMERGE Mothers and Kids follow up study are:
1. 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;
2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;
3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;
4. 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
Interventions
- OTHER
-
No intervention as the study is observational.
No intervention as the study is observational.
Sponsors & Collaborators
-
National University of Ireland, Galway, Ireland
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-09
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Ireland
Study Locations
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