Diagnoses Disease, Gestational Diabetes, Glucose, High Blood, Pregnancy in Diabetic
Conditions
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.
Interventions
BEHAVIORALFasting before gestational diabetes screen
Fasting for at least 6 hours before 1-hour gestational diabetes screen.
BEHAVIORALPer oral intake of food and drink
Per oral intake of food and drink within 2 hours of gestational diabetes screen
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Glucose Level at the OGTT Screen | Day of GDM screen (occurring between 24-28 weeks gestation) | — |
| 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. |
| 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 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 |
| Mean Gestational Age at Delivery | At time of delivery (Up to 42 weeks' gestation) | — |
| 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 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 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 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 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 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 With Post-partum Hemorrhage | Up to 6 weeks after delivery | This outcome was assessed in pregnant participants after delivery. |
| Mean Gestational Age at OGTT Screen | Day of GDM screen (occurring between 24-28 weeks gestation) | — |
| 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 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 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) | — |
| Number of Neonates With Birth Weight More Than 4000 Grams | Day of delivery (Within approximately 2 hours after delivery) | — |
| 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 With Hypoglycemia | Up to 28 days after delivery | — |
| Number of Neonates Diagnosed With Respiratory Distress Syndrome | Up to 28 days after delivery | — |
| Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge | Up to 28 days after delivery | — |
| 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. |
Countries
United States
Participant flow
Recruitment details
This study enrolled pregnant participants. While outcomes were assessed in neonates, they were not considered to be enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Fasting Before Gestational Diabetes Screen Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. | 100 |
| Fed Before Gestational Diabetes Screen Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did Not Receive Intervention | 3 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Fed Before Gestational Diabetes Screen | Total | Fasting Before Gestational Diabetes Screen |
|---|---|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 4.7 | 32.7 years STANDARD_DEVIATION 4.5 | 32.2 years STANDARD_DEVIATION 4.2 |
| Race/Ethnicity, Customized Asian/ Pacific Islander | 35 Participants | 74 Participants | 39 Participants |
| Race/Ethnicity, Customized Hispanic | 17 Participants | 23 Participants | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 40 Participants | 89 Participants | 49 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 9 Participants | 4 Participants |
| Region of Enrollment United States | 100 Participants | 200 Participants | 100 Participants |
| Sex: Female, Male Female | 100 Participants | 200 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 2 / 100 | 0 / 100 |
Outcome results
Primary
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)
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)
Population: Participants who completed the 1 hour GDM screen are included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before 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 |
| Fed Before 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) | 13 Participants |
p-value: 0.00295% CI: [7.2, 30.1]Fisher Exact
Secondary
Average Time of Last Oral Intake Prior to the OGTT Screen
Average number of hours since the participant's last oral intake prior to OGTT screen
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Population: Participants who completed the 1 hour GDM screen are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fasting Before Gestational Diabetes Screen | Average Time of Last Oral Intake Prior to the OGTT Screen | 10.7 hours | Standard Deviation 3 |
| Fed Before Gestational Diabetes Screen | Average Time of Last Oral Intake Prior to the OGTT Screen | 1.4 hours | Standard Deviation 0.9 |
Secondary
Length of Postnatal Stay From Delivery to Discharge
Average number of days admitted in the hospital after delivery up to discharge
Time frame: Up to 1 week after delivery
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fasting Before Gestational Diabetes Screen | Length of Postnatal Stay From Delivery to Discharge | 2.3 days | Standard Deviation 0.9 |
| Fed Before Gestational Diabetes Screen | Length of Postnatal Stay From Delivery to Discharge | 2.4 days | Standard Deviation 1.1 |
Secondary
Mean Gestational Age at Delivery
Time frame: At time of delivery (Up to 42 weeks' gestation)
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fasting Before Gestational Diabetes Screen | Mean Gestational Age at Delivery | 272 days | Standard Deviation 12 |
| Fed Before Gestational Diabetes Screen | Mean Gestational Age at Delivery | 272 days | Standard Deviation 10 |
Secondary
Mean Gestational Age at OGTT Screen
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Population: Participants who completed the 1 hour GDM screen are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fasting Before Gestational Diabetes Screen | Mean Gestational Age at OGTT Screen | 25.7 weeks | Standard Deviation 1.2 |
| Fed Before Gestational Diabetes Screen | Mean Gestational Age at OGTT Screen | 25.8 weeks | Standard Deviation 1.3 |
Secondary
Mean Glucose Level at the OGTT Screen
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Population: Participants who completed the 1 hour GDM screen are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fasting Before Gestational Diabetes Screen | Mean Glucose Level at the OGTT Screen | 127.7 mg/dL | Standard Deviation 35.8 |
| Fed Before Gestational Diabetes Screen | Mean Glucose Level at the OGTT Screen | 113.3 mg/dL | Standard Deviation 26.4 |
Secondary
Mean Neonatal Birthweight
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Population: Participants with a live birth are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fasting Before Gestational Diabetes Screen | Mean Neonatal Birthweight | 3231 grams | Standard Deviation 631 |
| Fed Before Gestational Diabetes Screen | Mean Neonatal Birthweight | 3268 grams | Standard Deviation 458 |
Secondary
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: Up to 28 days after delivery
Population: Participants with a live birth are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU) | 4 neonates |
| Fed Before Gestational Diabetes Screen | Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU) | 7 neonates |
Secondary
Number of Neonates Considered Large for Gestational Age (LGA)
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)
Population: Participants with a live birth are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Neonates Considered Large for Gestational Age (LGA) | 6 neonates |
| Fed Before Gestational Diabetes Screen | Number of Neonates Considered Large for Gestational Age (LGA) | 7 neonates |
Secondary
Number of Neonates Considered Small for Gestational Age (SGA)
SGA are infants whose weight is \< the 10th percentile for gestational age.
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Population: Participants with a live birth are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Neonates Considered Small for Gestational Age (SGA) | 6 neonates |
| Fed Before Gestational Diabetes Screen | Number of Neonates Considered Small for Gestational Age (SGA) | 9 neonates |
Secondary
Number of Neonates Diagnosed With Respiratory Distress Syndrome
Time frame: Up to 28 days after delivery
Population: Participants with a live birth are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Neonates Diagnosed With Respiratory Distress Syndrome | 7 neonates |
| Fed Before Gestational Diabetes Screen | Number of Neonates Diagnosed With Respiratory Distress Syndrome | 7 neonates |
Secondary
Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge
Time frame: Up to 28 days after delivery
Population: Participants with breast feeding data are included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge | 62 neonates |
| Fed Before Gestational Diabetes Screen | Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge | 59 neonates |
Secondary
Number of Neonates With Birth Weight More Than 4000 Grams
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Population: Participants with a live birth are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Neonates With Birth Weight More Than 4000 Grams | 6 neonates |
| Fed Before Gestational Diabetes Screen | Number of Neonates With Birth Weight More Than 4000 Grams | 6 neonates |
Secondary
Number of Neonates With Hyperbilirubinemia
Time frame: Up to 28 days after delivery
Population: Participants with a live birth are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Neonates With Hyperbilirubinemia | 7 neonates |
| Fed Before Gestational Diabetes Screen | Number of Neonates With Hyperbilirubinemia | 9 neonates |
Secondary
Number of Neonates With Hypoglycemia
Time frame: Up to 28 days after delivery
Population: Participants with a live birth are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Neonates With Hypoglycemia | 9 neonates |
| Fed Before Gestational Diabetes Screen | Number of Neonates With Hypoglycemia | 5 neonates |
Secondary
Number of Participants Complicated by Shoulder Dystocia at Delivery
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)
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Complicated by Shoulder Dystocia at Delivery | 0 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Complicated by Shoulder Dystocia at Delivery | 1 Participants |
Secondary
Number of Participants Complicated by Third or Fourth Degree Perineal Laceration
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: At time of delivery (up to 42 weeks' gestation)
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Complicated by Third or Fourth Degree Perineal Laceration | 2 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Complicated by Third or Fourth Degree Perineal Laceration | 4 Participants |
Secondary
Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy
This outcome was assessed in pregnant participants.
Time frame: From time of GDM screen up to 6 weeks after delivery
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy | 22 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy | 15 Participants |
Secondary
Number of Participants Who Delivered Vaginally
This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Who Delivered Vaginally | 67 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Who Delivered Vaginally | 53 Participants |
Secondary
Number of Participants Who Delivered Vaginally After a Prior Cesarean Section
This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Who Delivered Vaginally After a Prior Cesarean Section | 2 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Who Delivered Vaginally After a Prior Cesarean Section | 1 Participants |
Secondary
Number of Participants Who Delivered Via a Primary Cesarean Section
Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Who Delivered Via a Primary Cesarean Section | 17 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Who Delivered Via a Primary Cesarean Section | 21 Participants |
Secondary
Number of Participants Who Delivered Via a Repeat Cesarean Section
This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Who Delivered Via a Repeat Cesarean Section | 7 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Who Delivered Via a Repeat Cesarean Section | 14 Participants |
Secondary
Number of Participants Who Delivered Via Operative Vaginal Birth
This outcome was assessed in pregnant participants.
Time frame: At time of delivery (up to 42 weeks' gestation)
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Who Delivered Via Operative Vaginal Birth | 3 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Who Delivered Via Operative Vaginal Birth | 7 Participants |
Secondary
Number of Participants Who Had a Postpartum Readmission
This outcome was assessed in pregnant participants post-delivery.
Time frame: From initial hospital discharge up to 6 weeks post-partum
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants Who Had a Postpartum Readmission | 4 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants Who Had a Postpartum Readmission | 6 Participants |
Secondary
Number of Participants With Positive GDM Diagnosis
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
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants With Positive GDM Diagnosis | 12 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants With Positive GDM Diagnosis | 5 Participants |
Secondary
Number of Participants With Positive GDM Diagnosis Based on the OGTT
This outcome was assessed in pregnant participants.
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Population: Participants who completed the 1 hour GDM screen are included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants With Positive GDM Diagnosis Based on the OGTT | 8 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants With Positive GDM Diagnosis Based on the OGTT | 2 Participants |
Secondary
Number of Participants With Post-partum Hemorrhage
This outcome was assessed in pregnant participants after delivery.
Time frame: Up to 6 weeks after delivery
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants With Post-partum Hemorrhage | 16 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants With Post-partum Hemorrhage | 10 Participants |
Secondary
Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum
This outcome was assessed in pregnant participants after delivery.
Time frame: From time of delivery up to 6 weeks post-partum
Population: Participants who had delivery data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fasting Before Gestational Diabetes Screen | Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum | 1 Participants |
| Fed Before Gestational Diabetes Screen | Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum | 0 Participants |