Clinical trial NCT04547023: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Diagnoses Disease
Pregnancy in Diabetic
Glucose, High Blood
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-09-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Day of GDM screen (occurring between 24-28 weeks gestation)
Secondary outcomes:
measure: Mean Gestational Age at OGTT Screen
timeFrame: Day of GDM screen (occurring between 24-28 weeks gestation)
measure: Mean Glucose Level at the OGTT Screen
timeFrame: Day of GDM screen (occurring between 24-28 weeks gestation)
measure: Number of Participants With Positive GDM Diagnosis Based on the OGTT
timeFrame: Day of GDM screen (occurring between 24-28 weeks gestation)
measure: Average Time of Last Oral Intake Prior to the OGTT Screen
timeFrame: Day of GDM screen (occurring between 24-28 weeks gestation)
measure: Number of Participants With Positive GDM Diagnosis
timeFrame: Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation)
measure: Mean Gestational Age at Delivery
timeFrame: At time of delivery (Up to 42 weeks' gestation)
measure: Number of Participants Who Delivered Vaginally
timeFrame: At time of delivery (up to 42 weeks' gestation)
measure: Number of Participants Who Delivered Via Operative Vaginal Birth
timeFrame: At time of delivery (up to 42 weeks' gestation)
measure: Number of Participants Who Delivered Vaginally After a Prior Cesarean Section
timeFrame: At time of delivery (up to 42 weeks' gestation)
measure: Number of Participants Who Delivered Via a Primary Cesarean Section
timeFrame: At time of delivery (up to 42 weeks' gestation)
measure: Number of Participants Who Delivered Via a Repeat Cesarean Section
timeFrame: At time of delivery (up to 42 weeks' gestation)
measure: Number of Participants Complicated by Shoulder Dystocia at Delivery
timeFrame: At time of delivery (up to 42 weeks' gestation)
measure: Number of Participants Complicated by Third or Fourth Degree Perineal Laceration
timeFrame: At time of delivery (up to 42 weeks' gestation)
measure: Number of Participants With Post-partum Hemorrhage
timeFrame: Up to 6 weeks after delivery
measure: Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy
timeFrame: From time of GDM screen up to 6 weeks after delivery
measure: Length of Postnatal Stay From Delivery to Discharge
timeFrame: Up to 1 week after delivery
measure: Number of Participants Who Had a Postpartum Readmission
timeFrame: From initial hospital discharge up to 6 weeks post-partum
measure: Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum
timeFrame: From time of delivery up to 6 weeks post-partum
measure: Mean Neonatal Birthweight
timeFrame: Day of delivery (Within approximately 2 hours after delivery)
measure: Number of Neonates With Birth Weight More Than 4000 Grams
timeFrame: Day of delivery (Within approximately 2 hours after delivery)
measure: Number of Neonates Considered Large for Gestational Age (LGA)
timeFrame: Day of delivery (Within approximately 2 hours after delivery)
measure: Number of Neonates Considered Small for Gestational Age (SGA)
timeFrame: Day of delivery (Within approximately 2 hours after delivery)
measure: Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
timeFrame: Up to 28 days after delivery
measure: Number of Neonates With Hyperbilirubinemia
timeFrame: Up to 28 days after delivery
measure: Number of Neonates With Hypoglycemia
timeFrame: Up to 28 days after delivery
measure: Number of Neonates Diagnosed With Respiratory Distress Syndrome
timeFrame: Up to 28 days after delivery
measure: Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge
timeFrame: Up to 28 days after delivery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Associate Professor
name: Yair Blumenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: