Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy

Gestational Diabetes Clinical Trial

Official title:

Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547023
• Other study ID #: 57772
• Secondary ID: P30DK116074
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: October 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 1, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Pregnant patients 18 years and older

2. Singleton gestation

3. Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic

4. Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit

Exclusion Criteria:

1. Pregestational diabetes

2. Gestational diabetes diagnosed in the 1st trimester

3. Less than 18 years of age

4. Planned delivery outside LPCH

5. Diabetes medication use prior to pregnancy

6. Inability to give informed consent

7. Chronic steroid use in pregnancy

8. Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test

9. Prior history of bariatric surgery

10. Multifetal gestation

Related Conditions & MeSH terms

• Diabetes, Gestational
• Diagnoses Disease
• Gestational Diabetes
• Glucose, High Blood
• Pregnancy in Diabetic
• Pregnancy in Diabetics

Intervention

Behavioral:
• Fasting before gestational diabetes screen
Fasting for at least 6 hours before 1-hour gestational diabetes screen.
• Per oral intake of food and drink
Per oral intake of food and drink within 2 hours of gestational diabetes screen

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day of GDM screen (occurring between 24-28 weeks gestation)
Secondary	Mean Gestational Age at OGTT Screen		Day of GDM screen (occurring between 24-28 weeks gestation)
Secondary	Mean Glucose Level at the OGTT Screen		Day of GDM screen (occurring between 24-28 weeks gestation)
Secondary	Number of Participants With Positive GDM Diagnosis Based on the OGTT	This outcome was assessed in pregnant participants.	Day of GDM screen (occurring between 24-28 weeks gestation)
Secondary	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	Day of GDM screen (occurring between 24-28 weeks gestation)
Secondary	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	Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation)
Secondary	Mean Gestational Age at Delivery		At time of delivery (Up to 42 weeks' gestation)
Secondary	Number of Participants Who Delivered Vaginally	This outcome was assessed in pregnant participants.	At time of delivery (up to 42 weeks' gestation)
Secondary	Number of Participants Who Delivered Via Operative Vaginal Birth	This outcome was assessed in pregnant participants.	At time of delivery (up to 42 weeks' gestation)
Secondary	Number of Participants Who Delivered Vaginally After a Prior Cesarean Section	This outcome was assessed in pregnant participants.	At time of delivery (up to 42 weeks' gestation)
Secondary	Number of Participants Who Delivered Via a Primary Cesarean Section	Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.	At time of delivery (up to 42 weeks' gestation)
Secondary	Number of Participants Who Delivered Via a Repeat Cesarean Section	This outcome was assessed in pregnant participants.	At time of delivery (up to 42 weeks' gestation)
Secondary	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.	At time of delivery (up to 42 weeks' gestation)
Secondary	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.	At time of delivery (up to 42 weeks' gestation)
Secondary	Number of Participants With Post-partum Hemorrhage	This outcome was assessed in pregnant participants after delivery.	Up to 6 weeks after delivery
Secondary	Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy	This outcome was assessed in pregnant participants.	From time of GDM screen up to 6 weeks after delivery
Secondary	Length of Postnatal Stay From Delivery to Discharge	Average number of days admitted in the hospital after delivery up to discharge	Up to 1 week after delivery
Secondary	Number of Participants Who Had a Postpartum Readmission	This outcome was assessed in pregnant participants post-delivery.	From initial hospital discharge up to 6 weeks post-partum
Secondary	Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum	This outcome was assessed in pregnant participants after delivery.	From time of delivery up to 6 weeks post-partum
Secondary	Mean Neonatal Birthweight		Day of delivery (Within approximately 2 hours after delivery)
Secondary	Number of Neonates With Birth Weight More Than 4000 Grams		Day of delivery (Within approximately 2 hours after delivery)
Secondary	Number of Neonates Considered Large for Gestational Age (LGA)	LGA refers to neonatal birth weight larger than the 90th percentile for gestational age.	Day of delivery (Within approximately 2 hours after delivery)
Secondary	Number of Neonates Considered Small for Gestational Age (SGA)	SGA are infants whose weight is < the 10th percentile for gestational age.	Day of delivery (Within approximately 2 hours after delivery)
Secondary	Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)		Up to 28 days after delivery
Secondary	Number of Neonates With Hyperbilirubinemia		Up to 28 days after delivery
Secondary	Number of Neonates With Hypoglycemia		Up to 28 days after delivery
Secondary	Number of Neonates Diagnosed With Respiratory Distress Syndrome		Up to 28 days after delivery
Secondary	Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge		Up to 28 days after delivery