EMERGE Mothers and Kids

NCT ID: NCT06327191

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

321 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-09

Study Completion Date

2025-12-31

Brief Summary

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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:

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.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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No intervention as the study is observational.

No intervention as the study is observational.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* EMERGE trial participants who did not provide consent for further follow up studies.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National University of Ireland, Galway, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Fidelma Dunne

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Galway

Galway, , Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Fidelma Dunne, Prof

Role: CONTACT

091 495 964

Chloe Ryan

Role: CONTACT

0861436415

Facility Contacts

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Prof. Fidelma Dunne

Role: primary

Other Identifiers

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23-CRFG-21

Identifier Type: OTHER

Identifier Source: secondary_id

23-CRFG-21

Identifier Type: -

Identifier Source: org_study_id

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