RecruitingNCT06327191

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)


Sponsor

National University of Ireland, Galway, Ireland

Enrollment

321 participants

Start Date

Jul 9, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria1

  • Participation in the original EMERGE trial and consenting to further follow up.

Exclusion Criteria1

  • EMERGE trial participants who did not provide consent for further follow up studies.

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Interventions

OTHERNo intervention as the study is observational.

No intervention as the study is observational.


Locations(1)

University Hospital Galway

Galway, Ireland

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NCT06327191


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