Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327191
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-11-21
Brief Title:
EMERGE Mothers and Kids
Sponsor:
National University of Ireland Galway Ireland
Organization:
National University of Ireland Galway Ireland
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM N535 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-CRFG-21 | OTHER | Clinical Research Facility Galway CRFG study number | None |