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NCT Number: NCT04547023

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting before gestational diabetes screen

Behavioral

Fasting for at least 6 hours before 1-hour gestational diabetes screen.

Per oral intake of food and drink

Behavioral

Per oral intake of food and drink within 2 hours of gestational diabetes screen

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Mean Gestational Age at OGTT Screen

    Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)

  2. Mean Glucose Level at the OGTT Screen

    Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)

  3. Number of Participants With Positive GDM Diagnosis Based on the OGTT

    Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)

    This outcome was assessed in pregnant participants.

  4. Average Time of Last Oral Intake Prior to the OGTT Screen

    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

  5. Number of Participants With Positive GDM Diagnosis

    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):

    • Fasting glucose < 95;
    • One hour glucose < 180;
    • Two hour glucose < 155;
    • Three hour glucose < 140
  6. Mean Gestational Age at Delivery

    Time frame: At time of delivery (Up to 42 weeks' gestation)

  7. Number of Participants Who Delivered Vaginally

    Time frame: At time of delivery (up to 42 weeks' gestation)

    This outcome was assessed in pregnant participants.

  8. Number of Participants Who Delivered Via Operative Vaginal Birth

    Time frame: At time of delivery (up to 42 weeks' gestation)

    This outcome was assessed in pregnant participants.

  9. Number of Participants Who Delivered Vaginally After a Prior Cesarean Section

    Time frame: At time of delivery (up to 42 weeks' gestation)

    This outcome was assessed in pregnant participants.

  10. Number of Participants Who Delivered Via a Primary Cesarean Section

    Time frame: At time of delivery (up to 42 weeks' gestation)

    Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.

  11. Number of Participants Who Delivered Via a Repeat Cesarean Section

    Time frame: At time of delivery (up to 42 weeks' gestation)

    This outcome was assessed in pregnant participants.

  12. Number of Participants Complicated by Shoulder Dystocia at Delivery

    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.

  13. Number of Participants Complicated by Third or Fourth Degree Perineal Laceration

    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.

  14. Number of Participants With Post-partum Hemorrhage

    Time frame: Up to 6 weeks after delivery

    This outcome was assessed in pregnant participants after delivery.

  15. Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy

    Time frame: From time of GDM screen up to 6 weeks after delivery

    This outcome was assessed in pregnant participants.

  16. Length of Postnatal Stay From Delivery to Discharge

    Time frame: Up to 1 week after delivery

    Average number of days admitted in the hospital after delivery up to discharge

  17. Number of Participants Who Had a Postpartum Readmission

    Time frame: From initial hospital discharge up to 6 weeks post-partum

    This outcome was assessed in pregnant participants post-delivery.

  18. Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum

    Time frame: From time of delivery up to 6 weeks post-partum

    This outcome was assessed in pregnant participants after delivery.

  19. Mean Neonatal Birthweight

    Time frame: Day of delivery (Within approximately 2 hours after delivery)

  20. Number of Neonates With Birth Weight More Than 4000 Grams

    Time frame: Day of delivery (Within approximately 2 hours after delivery)

  21. Number of Neonates Considered Large for Gestational Age (LGA)

    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.

  22. Number of Neonates Considered Small for Gestational Age (SGA)

    Time frame: Day of delivery (Within approximately 2 hours after delivery)

    SGA are infants whose weight is < the 10th percentile for gestational age.

  23. Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)

    Time frame: Up to 28 days after delivery

  24. Number of Neonates With Hyperbilirubinemia

    Time frame: Up to 28 days after delivery

  25. Number of Neonates With Hypoglycemia

    Time frame: Up to 28 days after delivery

  26. Number of Neonates Diagnosed With Respiratory Distress Syndrome

    Time frame: Up to 28 days after delivery

  27. Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge

    Time frame: Up to 28 days after delivery

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2020
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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