NCT06327191

EMERGE Mothers and Kids

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 321 (estimated)
• Sponsor: National University of Ireland, Galway, Ireland · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
OTHER	No intervention as the study is observational.	No intervention as the study is observational.

Timeline

• Start date: 2024-07-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-03-25
• Last updated: 2024-07-19

Locations

1 site across 1 country: Ireland