Glucose Frequent of A1GDM in Labor

NCT06744621 | Completed

• 1 other identifier: STUDY-24-01116
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes, Controlled by Diet

Outcome Measures

Primary Outcomes (1)

• Neonatal glucose level

  at 24 hours

Secondary Outcomes (4)

• Number of neonates requiring insulin

  at 24 hours

• Number of NICU admissions

  at 24 hours

• Number of glucose treatments

  at 24 hours

• Number of neonatal with hyperbilirubinemia

  at 24 hours

Study Arms (2)

Infrequent

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

Other: Fingerstick

Frequent

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

Other: Fingerstick

Interventions

Fingerstick OTHER

fingersticks during their labor process

Frequent; Infrequent

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient with A1GDM (diet controlled gestational diabetes)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thomas Owens, MD

  Mount Sinai West

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellow

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: December 5, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)