Stanford University
Stanford, California, 94305, United States
NCT Number: NCT04547023
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.
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Female
Interventional
Not applicable
Stanford, California, 94305, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fasting for at least 6 hours before 1-hour gestational diabetes screen.
Per oral intake of food and drink within 2 hours of gestational diabetes screen
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
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)
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
This outcome was assessed in pregnant participants.
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Average number of hours since the participant's last oral intake prior to OGTT screen
Time frame: Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation)
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):
Time frame: At time of delivery (Up to 42 weeks' gestation)
Time frame: At time of delivery (up to 42 weeks' gestation)
This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
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)
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: Up to 6 weeks after delivery
This outcome was assessed in pregnant participants after delivery.
Time frame: From time of GDM screen up to 6 weeks after delivery
This outcome was assessed in pregnant participants.
Time frame: Up to 1 week after delivery
Average number of days admitted in the hospital after delivery up to discharge
Time frame: From initial hospital discharge up to 6 weeks post-partum
This outcome was assessed in pregnant participants post-delivery.
Time frame: From time of delivery up to 6 weeks post-partum
This outcome was assessed in pregnant participants after delivery.
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Time frame: Day of delivery (Within approximately 2 hours after delivery)
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)
SGA are infants whose weight is < the 10th percentile for gestational age.
Time frame: Up to 28 days after delivery
Time frame: Up to 28 days after delivery
Time frame: Up to 28 days after delivery
Time frame: Up to 28 days after delivery
Time frame: Up to 28 days after delivery
Stanford University
Other
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