Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
Primary Purpose
Gestational Diabetes, Diagnoses Disease, Pregnancy in Diabetic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fasting before gestational diabetes screen
Per oral intake of food and drink
Sponsored by
About this trial
This is an interventional diagnostic trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Pregnant patients 18 years and older
- Singleton gestation
- Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic
- Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit
Exclusion Criteria:
- Pregestational diabetes
- Gestational diabetes diagnosed in the 1st trimester
- Less than 18 years of age
- Planned delivery outside LPCH
- Diabetes medication use prior to pregnancy
- Inability to give informed consent
- Chronic steroid use in pregnancy
- Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test
- Prior history of bariatric surgery
- Multifetal gestation
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fasting before gestational diabetes screen
Fed before gestational diabetes screen
Arm Description
Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.
Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Outcomes
Primary Outcome Measures
Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT)
Number of positive GDM screen (>= 140 mg/dL) on the 1 hour 50-g oral glucose tolerance test conducted between 24-28 weeks gestation This outcome was assessed in pregnant participants.
Secondary Outcome Measures
Mean Gestational Age at OGTT Screen
Mean Glucose Level at the OGTT Screen
Number of Participants With Positive GDM Diagnosis Based on the OGTT
This outcome was assessed in pregnant participants.
Average Time of Last Oral Intake Prior to the OGTT Screen
Average number of hours since the participant's last oral intake prior to OGTT screen
Number of Participants With Positive GDM Diagnosis
GDM diagnosis based on 1-hour OGTT ≥ 180 mg/dL or 2 elevated values on the 3-hour OGTT using Carpenter and Coustan criteria. This outcome was assessed in pregnant participants
Carpenter and Coustan Criteria is as follows (if 2 or more values are elevated, this is gestational diabetes):
Fasting glucose < 95;
One hour glucose < 180;
Two hour glucose < 155;
Three hour glucose < 140
Mean Gestational Age at Delivery
Number of Participants Who Delivered Vaginally
This outcome was assessed in pregnant participants.
Number of Participants Who Delivered Via Operative Vaginal Birth
This outcome was assessed in pregnant participants.
Number of Participants Who Delivered Vaginally After a Prior Cesarean Section
This outcome was assessed in pregnant participants.
Number of Participants Who Delivered Via a Primary Cesarean Section
Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.
Number of Participants Who Delivered Via a Repeat Cesarean Section
This outcome was assessed in pregnant participants.
Number of Participants Complicated by Shoulder Dystocia at Delivery
Shoulder dystocia is a birth injury (also called birth trauma) that happens when one or both of a baby's shoulders get stuck inside the mother's pelvis during labor and birth. This outcome was assessed in pregnant participants.
Number of Participants Complicated by Third or Fourth Degree Perineal Laceration
A third degree tear is a tear or laceration through the perineal muscles and the anal sphincter. A fourth degree tear goes through the anal sphincter all the way to the anal canal or rectum. This outcome was assessed in pregnant participants.
Number of Participants With Post-partum Hemorrhage
This outcome was assessed in pregnant participants after delivery.
Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy
This outcome was assessed in pregnant participants.
Length of Postnatal Stay From Delivery to Discharge
Average number of days admitted in the hospital after delivery up to discharge
Number of Participants Who Had a Postpartum Readmission
This outcome was assessed in pregnant participants post-delivery.
Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum
This outcome was assessed in pregnant participants after delivery.
Mean Neonatal Birthweight
Number of Neonates With Birth Weight More Than 4000 Grams
Number of Neonates Considered Large for Gestational Age (LGA)
LGA refers to neonatal birth weight larger than the 90th percentile for gestational age.
Number of Neonates Considered Small for Gestational Age (SGA)
SGA are infants whose weight is < the 10th percentile for gestational age.
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
Number of Neonates With Hyperbilirubinemia
Number of Neonates With Hypoglycemia
Number of Neonates Diagnosed With Respiratory Distress Syndrome
Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge
Full Information
NCT ID
NCT04547023
First Posted
September 4, 2020
Last Updated
October 26, 2022
Sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04547023
Brief Title
Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
Official Title
Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine gestational diabetes screening results.
Detailed Description
Gestational diabetes (GDM) complicates approximately 400,000 pregnancies in the United States annually and is associated with significant adverse pregnancy outcomes, including increasing the lifetime risk of type 2 diabetes. The American College of Obstetricians and Gynecologists (ACOG) recommends that all pregnant women undergo GDM screening between 24-28 weeks gestation utilizing a 1-hour oral glucose tolerance test that was designed to be administered without regard to the last meal or time of day. However, studies suggest that the timing of one's last meal prior to the 1-hour GDM screen may have a significant impact on GDM screening glucose levels. In addition, providers routinely alter the timing of the 1-hour GDM screen based on patients' self reported oral intake prior to the exam. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine GDM screening results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Diagnoses Disease, Pregnancy in Diabetic, Glucose, High Blood
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fasting before gestational diabetes screen
Arm Type
Experimental
Arm Description
Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.
Arm Title
Fed before gestational diabetes screen
Arm Type
Active Comparator
Arm Description
Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Intervention Type
Behavioral
Intervention Name(s)
Fasting before gestational diabetes screen
Intervention Description
Fasting for at least 6 hours before 1-hour gestational diabetes screen.
Intervention Type
Behavioral
Intervention Name(s)
Per oral intake of food and drink
Intervention Description
Per oral intake of food and drink within 2 hours of gestational diabetes screen
Primary Outcome Measure Information:
Title
Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT)
Description
Number of positive GDM screen (>= 140 mg/dL) on the 1 hour 50-g oral glucose tolerance test conducted between 24-28 weeks gestation This outcome was assessed in pregnant participants.
Time Frame
Day of GDM screen (occurring between 24-28 weeks gestation)
Secondary Outcome Measure Information:
Title
Mean Gestational Age at OGTT Screen
Time Frame
Day of GDM screen (occurring between 24-28 weeks gestation)
Title
Mean Glucose Level at the OGTT Screen
Time Frame
Day of GDM screen (occurring between 24-28 weeks gestation)
Title
Number of Participants With Positive GDM Diagnosis Based on the OGTT
Description
This outcome was assessed in pregnant participants.
Time Frame
Day of GDM screen (occurring between 24-28 weeks gestation)
Title
Average Time of Last Oral Intake Prior to the OGTT Screen
Description
Average number of hours since the participant's last oral intake prior to OGTT screen
Time Frame
Day of GDM screen (occurring between 24-28 weeks gestation)
Title
Number of Participants With Positive GDM Diagnosis
Description
GDM diagnosis based on 1-hour OGTT ≥ 180 mg/dL or 2 elevated values on the 3-hour OGTT using Carpenter and Coustan criteria. This outcome was assessed in pregnant participants
Carpenter and Coustan Criteria is as follows (if 2 or more values are elevated, this is gestational diabetes):
Fasting glucose < 95;
One hour glucose < 180;
Two hour glucose < 155;
Three hour glucose < 140
Time Frame
Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation)
Title
Mean Gestational Age at Delivery
Time Frame
At time of delivery (Up to 42 weeks' gestation)
Title
Number of Participants Who Delivered Vaginally
Description
This outcome was assessed in pregnant participants.
Time Frame
At time of delivery (up to 42 weeks' gestation)
Title
Number of Participants Who Delivered Via Operative Vaginal Birth
Description
This outcome was assessed in pregnant participants.
Time Frame
At time of delivery (up to 42 weeks' gestation)
Title
Number of Participants Who Delivered Vaginally After a Prior Cesarean Section
Description
This outcome was assessed in pregnant participants.
Time Frame
At time of delivery (up to 42 weeks' gestation)
Title
Number of Participants Who Delivered Via a Primary Cesarean Section
Description
Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.
Time Frame
At time of delivery (up to 42 weeks' gestation)
Title
Number of Participants Who Delivered Via a Repeat Cesarean Section
Description
This outcome was assessed in pregnant participants.
Time Frame
At time of delivery (up to 42 weeks' gestation)
Title
Number of Participants Complicated by Shoulder Dystocia at Delivery
Description
Shoulder dystocia is a birth injury (also called birth trauma) that happens when one or both of a baby's shoulders get stuck inside the mother's pelvis during labor and birth. This outcome was assessed in pregnant participants.
Time Frame
At time of delivery (up to 42 weeks' gestation)
Title
Number of Participants Complicated by Third or Fourth Degree Perineal Laceration
Description
A third degree tear is a tear or laceration through the perineal muscles and the anal sphincter. A fourth degree tear goes through the anal sphincter all the way to the anal canal or rectum. This outcome was assessed in pregnant participants.
Time Frame
At time of delivery (up to 42 weeks' gestation)
Title
Number of Participants With Post-partum Hemorrhage
Description
This outcome was assessed in pregnant participants after delivery.
Time Frame
Up to 6 weeks after delivery
Title
Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy
Description
This outcome was assessed in pregnant participants.
Time Frame
From time of GDM screen up to 6 weeks after delivery
Title
Length of Postnatal Stay From Delivery to Discharge
Description
Average number of days admitted in the hospital after delivery up to discharge
Time Frame
Up to 1 week after delivery
Title
Number of Participants Who Had a Postpartum Readmission
Description
This outcome was assessed in pregnant participants post-delivery.
Time Frame
From initial hospital discharge up to 6 weeks post-partum
Title
Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum
Description
This outcome was assessed in pregnant participants after delivery.
Time Frame
From time of delivery up to 6 weeks post-partum
Title
Mean Neonatal Birthweight
Time Frame
Day of delivery (Within approximately 2 hours after delivery)
Title
Number of Neonates With Birth Weight More Than 4000 Grams
Time Frame
Day of delivery (Within approximately 2 hours after delivery)
Title
Number of Neonates Considered Large for Gestational Age (LGA)
Description
LGA refers to neonatal birth weight larger than the 90th percentile for gestational age.
Time Frame
Day of delivery (Within approximately 2 hours after delivery)
Title
Number of Neonates Considered Small for Gestational Age (SGA)
Description
SGA are infants whose weight is < the 10th percentile for gestational age.
Time Frame
Day of delivery (Within approximately 2 hours after delivery)
Title
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
Time Frame
Up to 28 days after delivery
Title
Number of Neonates With Hyperbilirubinemia
Time Frame
Up to 28 days after delivery
Title
Number of Neonates With Hypoglycemia
Time Frame
Up to 28 days after delivery
Title
Number of Neonates Diagnosed With Respiratory Distress Syndrome
Time Frame
Up to 28 days after delivery
Title
Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge
Time Frame
Up to 28 days after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant patients 18 years and older
Singleton gestation
Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic
Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit
Exclusion Criteria:
Pregestational diabetes
Gestational diabetes diagnosed in the 1st trimester
Less than 18 years of age
Planned delivery outside LPCH
Diabetes medication use prior to pregnancy
Inability to give informed consent
Chronic steroid use in pregnancy
Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test
Prior history of bariatric surgery
Multifetal gestation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Blumenfeld, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
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