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Intrapartum Glycemic Control for Gestational Diabetes
N/A
Recruiting
Led By Jean W Thermolice, MD
Research Sponsored by Inova Health Care Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intrapartum
Awards & highlights
Study Summary
This trial aims to assess the effects of tight vs. relaxed intrapartum glucose control on newborns of mothers with GDM. Data from the trial will help inform national guidelines.
Who is the study for?
This trial is for women over 18 with a single, non-anomalous baby and gestational diabetes type A2 diagnosed after 24 weeks. They must plan a vaginal delivery at term in Inova Fairfax Women's Hospital. It excludes those under 18, with pre-existing diabetes, twins or more, major fetal malformations, recent steroid use, scheduled cesarean birth or preterm delivery.Check my eligibility
What is being tested?
The study compares two approaches to manage blood sugar during labor for women with gestational diabetes: checking blood sugar every 2 hours versus every 4 hours. The goal is to see which method better prevents low blood sugar in newborns without existing national guidelines.See study design
What are the potential side effects?
Potential side effects may include discomfort from frequent blood draws and stress related to monitoring. There might also be risks of managing glucose levels too tightly or not enough, affecting both mother and child.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first 24 hours after delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 24 hours after delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Initial neonatal glucose post delivery
Secondary outcome measures
Mean neonatal glucose within the first 24 hours post-delivery
Mother's childbirth experience score
Neonatal hypoglycemia
+4 moreOther outcome measures
Intrapartum glycemia mean
Intrapartum insulin dose (total)
Intrapartum insulin use
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Usual care glycemic management armActive Control1 Intervention
Blood glucose will be checked every 2 hours during labor and glucose target will be 75-110 mg/dl
Group II: More liberalized glycemic management armActive Control1 Intervention
Blood glucose will be checked every 4 hours during labor and glucose target will be 70-126 mg/dl
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Who is running the clinical trial?
Inova Health Care ServicesLead Sponsor
69 Previous Clinical Trials
22,135 Total Patients Enrolled
Jean W Thermolice, MDPrincipal InvestigatorInova Healthcare Services
1 Previous Clinical Trials
900 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Unborn baby has severe birth defects.Being born too earlyYou have been diagnosed with type A2 gestational diabetes after being 24 weeks pregnant or more.I am a woman under 18 years old.I was given steroids less than 14 days before giving birth.You are pregnant with only one baby and there are no complications.I have diabetes.I am a woman aged 18 or older.You had a cesarean birth before your cervix was dilated to 4-5 centimeters.You are planning to have a cesarean birth.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care glycemic management arm
- Group 2: More liberalized glycemic management arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team still seeking participants for this experiment?
"The information on clinicaltrials.gov reveals that this trial is not presently enrolling participants, with its last update having been made on December 3rd 2022. However, there are currently 267 other trials looking for recruits right now."
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