EMERGE Mothers and Kids

Last updated: July 18, 2024
Sponsor: National University of Ireland, Galway, Ireland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Pregnancy Complications

Diabetes And Hypertension

Treatment

No intervention as the study is observational.

Clinical Study ID

NCT06327191
23-CRFG-21
23-CRFG-21
  • Ages 18-50
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 321
Treatment Group(s): 1
Primary Treatment: No intervention as the study is observational.
Phase:
Study Start date:
July 09, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • University Hospital Galway

    Galway,
    Ireland

    Active - Recruiting

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