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Infrequent testing for Neonatal Hypoglycemia

N/A

Waitlist Available

Led By Thomas Owens, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All female patients of reproductive age who have the diagnosis GDM

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study at 6 months

Awards & highlights

Study Summary

This trial aims to compare different protocols for monitoring blood sugar levels in pregnant women with Gestational Diabetes Mellitus during labor. The study will randomly assign patients to either regular or less frequent blood sugar monitoring,

Who is the study for?

This trial is for pregnant individuals with Gestational Diabetes Mellitus (GDM). It's designed to see if the frequency of checking blood sugar levels during labor affects their newborns' risk of low blood sugar. Participants will be randomly assigned to either 'frequent' or 'infrequent' glucose monitoring groups.Check my eligibility

What is being tested?

The study tests two different approaches to monitor blood sugar in laboring mothers with GDM: one group will have their glucose checked frequently, while the other less so. The main goal is to observe how these methods impact the baby's blood sugar level at birth.See study design

What are the potential side effects?

Since this trial involves fingerstick testing for glucose levels, potential side effects are minimal and may include discomfort or bruising at the site of the finger prick.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am of childbearing age and have been diagnosed with gestational diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neonatal Hypoglycemia

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Infrequent testingExperimental Treatment1 Intervention

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

Group II: Frequent testingPlacebo Group1 Intervention

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

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,348 Total Patients Enrolled

Thomas Owens, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"Per the details on clinicaltrials.gov, recruitment for this particular trial is closed. The trial information was first published on April 1st, 2024 and last modified on April 15th, 2024. Although this study is not open for enrollment anymore, it's worth noting that there are currently 77 other trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Frequency of Glucose Monitoring in Labor

Thomas Owens 2024. "Frequency of Glucose Monitoring in Labor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06373432.

All > Hypoglycemia