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

Not Applicable

Completed

• Conditions: Gestational Diabetes; Diagnoses Disease; Pregnancy in Diabetic; Glucose, High Blood
• Interventions: Behavioral: Fasting before gestational diabetes screen; Behavioral: Per oral intake of food and drink

• Registration Number: NCT04547023
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-14
• Study Start: 2020-11-02
• Primary Completion: 2021-06-21
• Study Completion: 2021-11-01
• Results First Submitted: 2022-06-17
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Results First Posted: 2022-11-21
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting before gestational diabetes screen	Fasting before gestational diabetes screen	Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.
Fed before gestational diabetes screen	Per oral intake of food and drink	Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.

Primary Outcome Measures

Name	Time	Method
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)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Delivered Vaginally	At time of delivery (up to 42 weeks' gestation)	This outcome was assessed in pregnant participants.
Number of Participants With Positive GDM Diagnosis Based on the OGTT	Day of GDM screen (occurring between 24-28 weeks gestation)	This outcome was assessed in pregnant participants.
Number of Participants With Positive GDM Diagnosis	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): * Fasting glucose \< 95; * One hour glucose \< 180; * Two hour glucose \< 155; * Three hour glucose \< 140
Number of Neonates Considered Large for Gestational Age (LGA)	Day of delivery (Within approximately 2 hours after delivery)	LGA refers to neonatal birth weight larger than the 90th percentile for gestational age.
Number of Neonates Considered Small for Gestational Age (SGA)	Day of delivery (Within approximately 2 hours after delivery)	SGA are infants whose weight is \< the 10th percentile for gestational age.
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)	Up to 28 days after delivery
Number of Neonates With Hyperbilirubinemia	Up to 28 days after delivery
Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge	Up to 28 days after delivery
Mean Glucose Level at the OGTT Screen	Day of GDM screen (occurring between 24-28 weeks gestation)
Mean Gestational Age at Delivery	At time of delivery (Up to 42 weeks' gestation)
Number of Participants Who Delivered Via a Repeat Cesarean Section	At time of delivery (up to 42 weeks' gestation)	This outcome was assessed in pregnant participants.
Number of Participants Complicated by Shoulder Dystocia at Delivery	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.
Number of Participants With Post-partum Hemorrhage	Up to 6 weeks after delivery	This outcome was assessed in pregnant participants after delivery.
Number of Neonates With Hypoglycemia	Up to 28 days after delivery
Number of Neonates Diagnosed With Respiratory Distress Syndrome	Up to 28 days after delivery
Mean Gestational Age at OGTT Screen	Day of GDM screen (occurring between 24-28 weeks gestation)
Number of Participants Who Delivered Vaginally After a Prior Cesarean Section	At time of delivery (up to 42 weeks' gestation)	This outcome was assessed in pregnant participants.
Number of Participants Complicated by Third or Fourth Degree Perineal Laceration	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.
Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy	From time of GDM screen up to 6 weeks after delivery	This outcome was assessed in pregnant participants.
Length of Postnatal Stay From Delivery to Discharge	Up to 1 week after delivery	Average number of days admitted in the hospital after delivery up to discharge
Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum	From time of delivery up to 6 weeks post-partum	This outcome was assessed in pregnant participants after delivery.
Mean Neonatal Birthweight	Day of delivery (Within approximately 2 hours after delivery)
Average Time of Last Oral Intake Prior to the OGTT Screen	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
Number of Participants Who Delivered Via Operative Vaginal Birth	At time of delivery (up to 42 weeks' gestation)	This outcome was assessed in pregnant participants.
Number of Participants Who Delivered Via a Primary Cesarean Section	At time of delivery (up to 42 weeks' gestation)	Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.
Number of Participants Who Had a Postpartum Readmission	From initial hospital discharge up to 6 weeks post-partum	This outcome was assessed in pregnant participants post-delivery.
Number of Neonates With Birth Weight More Than 4000 Grams	Day of delivery (Within approximately 2 hours after delivery)

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States