Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT02708758
Status:
UNKNOWN
Last Update Posted:
2021-12-28
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Treatment for Gestational Diabetes Diagnosed by the IADPSG Criteria.
Sponsor:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Organization:
Study Overview
Official Title:
Efficacy of Treatment in Women With Gestational Diabetes Mellitus Diagnosed by One Altered Value by the International Association of Diabetes and Pregnancy Study Groups Criteria (IADPSG).
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
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:
There is a lack of international uniformity in the approach to the screening and diagnosis of gestational diabetes mellitus (GDM). The new diagnostic criteria by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) based on data from the study of Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) have created controversy because of the lack of clinical evidence of treatment benefit for mild GDM and the treatment effects on perinatal outcomes. The purpose of the present study is to know the efficacy of treatment to reduce adverse pregnancy outcomes in Mexican women diagnosed with GDM by IADPSG criteria.
Detailed Description:
Currently no evidence from randomized clinical trials on the efficacy of treatment of gestational diabetes mellitus (GDM), diagnosed by a single altered value during a 75g oral glucose tolerance test (75g OGTT), proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) to reduce adverse perinatal outcomes (APO). In our institution GDM diagnosis is established with two or more altered values during 75g OGTT, women with one altered value during OGTT are not considered GDM and therefore those women do not receive specific treatment for GDM. We conduct an open randomized clinical trial, two groups, Group 1 (women with treatment for GDM) and group 2 (women with routine care). The diagnosis of GDM will be perform with a single altered value during 75g OGTT: fasting ≥ 92mg / dL, 1-hour ≥ 180 mg / dL and 2-hours ≥ 153 mg / dL. Treatment consist of medical nutritional therapy (MNT), which includes restricted diet 45% carbohydrate, exercise and self-monitoring of glucose, if not reach therapeutic goals metformin and / or insulin will be added.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 212250-3402-10102-02-14 | REGISTRY | Instituto Nacional de Perinatología, (INPer) | View |