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Dietary Supplement
Carbohydrate Drink Before Cesarean Section for Newborn Blood Glucose
N/A
Recruiting
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women with term pregnancies
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60-120 minutes of life
Awards & highlights
Study Summary
This trial will test if a carbohydrate-rich drink given before surgery has an effect on newborn glucose levels.
Who is the study for?
This trial is for non-laboring women over 18, planning a cesarean section at term with intact amniotic membranes, who speak English or Spanish. They must have fasted for at least 8 hours and completed glucose screening during pregnancy. Women in labor, with fetal anomalies, or a history of galactosemia cannot participate.Check my eligibility
What is being tested?
The study is testing if drinking a carbohydrate-rich drink before a cesarean section affects the baby's blood sugar levels after birth. It's an equivalence trial where participants are randomly chosen to either receive the drink or not before their surgery.See study design
What are the potential side effects?
Since this trial involves consuming a preoperative carbohydrate drink, potential side effects may include digestive discomfort such as nausea or bloating. However, these types of drinks are generally well-tolerated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have carried a pregnancy to term.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60-120 minutes of life
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-120 minutes of life
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neonatal glucose (mg/dl)
Secondary outcome measures
Neonatal glucose 2 (mg/dl)
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Non-diabetic CHO DrinkExperimental Treatment1 Intervention
Patients without diabetes. Commercially available preoperative carbohydrate drink will be administered two hours prior to cesarean section.
Group II: Diabetic CHO DrinkExperimental Treatment1 Intervention
Patients with diabetes. Commercially available preoperative carbohydrate drink will be administered two hours prior to cesarean section.
Group III: Diabetic ControlActive Control1 Intervention
Patients with diabetes. No intervention will be administered - standard care.
Group IV: Non-diabetic ControlActive Control1 Intervention
Patients without diabetes. No intervention will be administered - standard care.
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,055 Total Patients Enrolled
Nova BiomedicalIndustry Sponsor
9 Previous Clinical Trials
2,137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fluent in English or Spanish.I am under 18 years old.I have carried a pregnancy to term.I have a history of galactosemia.
Research Study Groups:
This trial has the following groups:- Group 1: Diabetic CHO Drink
- Group 2: Diabetic Control
- Group 3: Non-diabetic Control
- Group 4: Non-diabetic CHO Drink
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.
Are there any open slots available for participants in this clinical trial?
"Affirmative. According to the information found on clinicaltrials.gov, this trial is currently recruiting subjects; it was first posted on October 20th 2021 and last updated a few days later. The investigators are aiming to enrol 216 participants from one medical centre in total."
Answered by AI
To what extent is the recruitment process for this trial progressing?
"Affirmative. Clinicaltrials.gov records indicate that this trial, which was first posted on October 20th 2021, is presently enlisting patients. The medical study requires 216 participants from a single location to be recruited."
Answered by AI
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