NCT06373432

Brief Summary

The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

July 2, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

April 15, 2024

Last Update Submit

July 1, 2025

Conditions

Neonatal Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Neonatal Hypoglycemia

    Glucose values of neonate measured in mg/dL

    end of study at 6 months

Study Arms (2)

Infrequent testing

EXPERIMENTAL

Finger sticks every 4 hours in latent labor (less than 5cm cervical dilation) and every 2 hours in active labor (6cm and greater)

Other: Fingerstick

Frequent testing

PLACEBO COMPARATOR

Finger sticks every 2 hours in latent labor (less than 5cm cervical dilation) and every 1 hours in active labor (6cm and greater)

Other: Fingerstick

Interventions

FingerstickOTHER

Fingerstick to check glucose value during labor.

Frequent testingInfrequent testing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All female patients of reproductive age who have the diagnosis GDM
  • Patient with singleton gestation presenting in labor or for induction

You may not qualify if:

  • Patients below the age of 18
  • Multiple gestation pregnancy
  • Patients undergoing scheduled c-section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai West Hospital

New York, New York, 10019, United States

Location

Study Officials

  • Thomas Owens, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 18, 2024

Study Start

May 1, 2024

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

July 2, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)