Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589141
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes a Randomized Controlled Trial GDM-MERGE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare the maternal fetal and neonatal outcomes associated with the use of metformin versus glyburide for managing gestational diabetes
The objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy
The objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy
Detailed Description:
Primary Outcome treatment failure is defined as the initiation of insulin due to failure of glycemic control more than 10 of high values using 4-point glucose checks or side effects
Secondary Outcomes
Maternal
Percentage of fasting and postprandial glucose levels within target levels after initiation of treatment
Incidence of maternal hypoglycemia
Reported maternal side effects
Maternal weight gain
Preterm delivery
Development of pregnancy-induced hypertension
Labor dystocia
Instrumental delivery and its indication fetal compromise delay in progress or maternal exhaustion
Mode of delivery
Incidence of third and fourth perineal tear
Fetal and neonatal
Fetal large for gestational age
Intrauterine fetal death
Newborn weight
Gestational age at delivery
Neonatal birth injuries
Stillbirth and neonatal death
Apgar score at 1 minute
Secondary Outcomes
Maternal
Percentage of fasting and postprandial glucose levels within target levels after initiation of treatment
Incidence of maternal hypoglycemia
Reported maternal side effects
Maternal weight gain
Preterm delivery
Development of pregnancy-induced hypertension
Labor dystocia
Instrumental delivery and its indication fetal compromise delay in progress or maternal exhaustion
Mode of delivery
Incidence of third and fourth perineal tear
Fetal and neonatal
Fetal large for gestational age
Intrauterine fetal death
Newborn weight
Gestational age at delivery
Neonatal birth injuries
Stillbirth and neonatal death
Apgar score at 1 minute
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None