Trial Outcomes & Findings for Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy (NCT NCT04547023)

NCT ID: NCT04547023

Last Updated: 2022-11-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: Day of GDM screen (occurring between 24-28 weeks gestation)
• Results posted on: 2022-11-21

Participant Flow

This study enrolled pregnant participants. While outcomes were assessed in neonates, they were not considered to be enrolled.

Participant milestones

Measure	Fasting Before Gestational Diabetes Screen Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Overall Study STARTED	100	100
Overall Study COMPLETED	96	97
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Fasting Before Gestational Diabetes Screen Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Overall Study Did Not Receive Intervention	3	2
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Fasting Before Gestational Diabetes Screen n=100 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=100 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.	Total n=200 Participants Total of all reporting groups
Age, Continuous	32.2 years STANDARD_DEVIATION 4.2 • n=5 Participants	33.2 years STANDARD_DEVIATION 4.7 • n=7 Participants	32.7 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian/ Pacific Islander	39 Participants n=5 Participants	35 Participants n=7 Participants	74 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	17 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	49 Participants n=5 Participants	40 Participants n=7 Participants	89 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants

PRIMARY outcome

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

Population: Participants who completed the 1 hour GDM screen are included in the analysis

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.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=97 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=98 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
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)	31 Participants	13 Participants

SECONDARY outcome

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

Population: Participants who completed the 1 hour GDM screen are included in the analysis

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=97 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=98 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Mean Gestational Age at OGTT Screen	25.7 weeks Standard Deviation 1.2	25.8 weeks Standard Deviation 1.3

SECONDARY outcome

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

Population: Participants who completed the 1 hour GDM screen are included in the analysis

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=97 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=98 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Mean Glucose Level at the OGTT Screen	127.7 mg/dL Standard Deviation 35.8	113.3 mg/dL Standard Deviation 26.4

SECONDARY outcome

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

Population: Participants who completed the 1 hour GDM screen are included in the analysis

This outcome was assessed in pregnant participants.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=97 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=98 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants With Positive GDM Diagnosis Based on the OGTT	8 Participants	2 Participants

SECONDARY outcome

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

Population: Participants who completed the 1 hour GDM screen are included in the analysis

Average number of hours since the participant's last oral intake prior to OGTT screen

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=97 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=98 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Average Time of Last Oral Intake Prior to the OGTT Screen	10.7 hours Standard Deviation 3.0	1.4 hours Standard Deviation 0.9

SECONDARY outcome

Timeframe: Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation)

Population: Participants who completed the 1 hour GDM screen are included in the analysis

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

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=97 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=98 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants With Positive GDM Diagnosis	12 Participants	5 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Mean Gestational Age at Delivery	272 days Standard Deviation 12	272 days Standard Deviation 10

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

This outcome was assessed in pregnant participants.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Who Delivered Vaginally	67 Participants	53 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

This outcome was assessed in pregnant participants.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Who Delivered Via Operative Vaginal Birth	3 Participants	7 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

This outcome was assessed in pregnant participants.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Who Delivered Vaginally After a Prior Cesarean Section	2 Participants	1 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

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

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Who Delivered Via a Primary Cesarean Section	17 Participants	21 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

This outcome was assessed in pregnant participants.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Who Delivered Via a Repeat Cesarean Section	7 Participants	14 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

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.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Complicated by Shoulder Dystocia at Delivery	0 Participants	1 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

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.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Complicated by Third or Fourth Degree Perineal Laceration	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks after delivery

Population: Participants who had delivery data are included in the analysis.

This outcome was assessed in pregnant participants after delivery.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants With Post-partum Hemorrhage	16 Participants	10 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

This outcome was assessed in pregnant participants.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy	22 Participants	15 Participants

SECONDARY outcome

Timeframe: Up to 1 week after delivery

Population: Participants who had delivery data are included in the analysis.

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

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Length of Postnatal Stay From Delivery to Discharge	2.3 days Standard Deviation 0.9	2.4 days Standard Deviation 1.1

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

This outcome was assessed in pregnant participants post-delivery.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants Who Had a Postpartum Readmission	4 Participants	6 Participants

SECONDARY outcome

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

Population: Participants who had delivery data are included in the analysis.

This outcome was assessed in pregnant participants after delivery.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=96 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day of delivery (Within approximately 2 hours after delivery)

Population: Participants with a live birth are included in the analysis.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=95 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Mean Neonatal Birthweight	3231 grams Standard Deviation 631	3268 grams Standard Deviation 458

SECONDARY outcome

Timeframe: Day of delivery (Within approximately 2 hours after delivery)

Population: Participants with a live birth are included in the analysis.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=95 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Neonates With Birth Weight More Than 4000 Grams	6 neonates	6 neonates

SECONDARY outcome

Timeframe: Day of delivery (Within approximately 2 hours after delivery)

Population: Participants with a live birth are included in the analysis.

LGA refers to neonatal birth weight larger than the 90th percentile for gestational age.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=95 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Neonates Considered Large for Gestational Age (LGA)	6 neonates	7 neonates

SECONDARY outcome

Timeframe: Day of delivery (Within approximately 2 hours after delivery)

Population: Participants with a live birth are included in the analysis.

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

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=95 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Neonates Considered Small for Gestational Age (SGA)	6 neonates	9 neonates

SECONDARY outcome

Timeframe: Up to 28 days after delivery

Population: Participants with a live birth are included in the analysis.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=95 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)	4 neonates	7 neonates

SECONDARY outcome

Timeframe: Up to 28 days after delivery

Population: Participants with a live birth are included in the analysis.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=95 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Neonates With Hyperbilirubinemia	7 neonates	9 neonates

SECONDARY outcome

Timeframe: Up to 28 days after delivery

Population: Participants with a live birth are included in the analysis.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=95 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Neonates With Hypoglycemia	9 neonates	5 neonates

SECONDARY outcome

Timeframe: Up to 28 days after delivery

Population: Participants with a live birth are included in the analysis.

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=96 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=95 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Neonates Diagnosed With Respiratory Distress Syndrome	7 neonates	7 neonates

SECONDARY outcome

Timeframe: Up to 28 days after delivery

Population: Participants with breast feeding data are included in the analysis

Outcome measures

Measure	Fasting Before Gestational Diabetes Screen n=86 Participants Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=88 Participants Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge	62 neonates	59 neonates

Adverse Events

Fasting Before Gestational Diabetes Screen

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Fed Before Gestational Diabetes Screen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fasting Before Gestational Diabetes Screen n=100 participants at risk Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.	Fed Before Gestational Diabetes Screen n=100 participants at risk Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Pregnancy, puerperium and perinatal conditions Intrauterine fetal demise	1.0% 1/100 • Up to 22 weeks (from 24 weeks gestation up to 6 weeks post-partum)	0.00% 0/100 • Up to 22 weeks (from 24 weeks gestation up to 6 weeks post-partum)
Congenital, familial and genetic disorders Congenital anomaly	1.0% 1/100 • Up to 22 weeks (from 24 weeks gestation up to 6 weeks post-partum)	0.00% 0/100 • Up to 22 weeks (from 24 weeks gestation up to 6 weeks post-partum)

Other adverse events

Adverse event data not reported

Additional Information

Yair Blumenfeld, MD

Stanford University

Phone: 650-498-4069

Email: yairb@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place