Glucose Frequent of A1GDM in Labor

NCT ID: NCT06744621

Last Updated: 2025-07-15

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-05

Study Completion Date

2025-05-30

Brief Summary

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This is a prospective double arm study in patients with Gestational Diabetes Mellitus (GDM) utilizing frequent (single fingerstick on admission) vs infrequent glucose monitoring in labor (q 4 hours in latent labor and every 2 hours in active labor). Primary Objective: The primary outcome is glucose value of the neonate at birth. Secondary Objectives: Determine rates of insulin requirements within different monitoring techniques. Determine if there is a difference in neonatal intensive care unit (NICU) admission within different monitoring techniques. Determine neonatal blood glucose concentrations at 24 hours of life, number of glucose treatments, and neonatal hyperbilirubinemia. Secondary characteristics to be viewed for each diagnosis; BMI, race, age, and parity.

Detailed Description

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Conditions

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Gestational Diabetes, Controlled by Diet

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infrequent

Patients will undergo one fingerstick on admission for their labor process.

Fingerstick

Intervention Type OTHER

fingersticks during their labor process

Frequent

Patients will undergo fingersticks every 4 hours in latent labor and 2 hour in active labor during their labor process.

Fingerstick

Intervention Type OTHER

fingersticks during their labor process

Interventions

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Fingerstick

fingersticks during their labor process

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All female patients of reproductive age (menarche-menopause: 18-51 years) who have the diagnosis diet controlled GDM
* Patient with singleton gestation presenting in labor or for induction
* Patients who had "good" glucose control and were A1GDM. Good Control;

* \- Patient with overall outpatient glucose average of less than 100
* \- No evidence of fetopathy, large for gestational age or polyhydramnios.
* \- Hgb A1c \<5.7

Exclusion Criteria

• If patient's admission accu check is \>120
Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Thomas Owens

Maternal Fetal Medicine Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Owens, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai West

Locations

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Mount Sinai West

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY-24-01116

Identifier Type: -

Identifier Source: org_study_id

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