| 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. | Participants who completed the 1 hour GDM screen are included in the analysis | Posted | | Count of Participants | | Participants | | Day of GDM screen (occurring between 24-28 weeks gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Fisher Exact | | 0.002 | | Mean Difference (Final Values) | 18.7 | | | 2-Sided | 95 | 7.2 | 30.1 | | | | | Other | | |
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| Secondary | Mean Gestational Age at OGTT Screen | | Participants who completed the 1 hour GDM screen are included in the analysis | Posted | | Mean | Standard Deviation | weeks | | Day of GDM screen (occurring between 24-28 weeks gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. |
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| Secondary | Mean Glucose Level at the OGTT Screen | | Participants who completed the 1 hour GDM screen are included in the analysis | Posted | | Mean | Standard Deviation | mg/dL | | Day of GDM screen (occurring between 24-28 weeks gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. |
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| Secondary | Number of Participants With Positive GDM Diagnosis Based on the OGTT | This outcome was assessed in pregnant participants. | Participants who completed the 1 hour GDM screen are included in the analysis | Posted | | Count of Participants | | Participants | | Day of GDM screen (occurring between 24-28 weeks gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| 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 | Participants who completed the 1 hour GDM screen are included in the analysis | Posted | | Mean | Standard Deviation | hours | | Day of GDM screen (occurring between 24-28 weeks gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| 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
| Participants who completed the 1 hour GDM screen are included in the analysis | Posted | | Count of Participants | | Participants | | Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Mean Gestational Age at Delivery | | Participants who had delivery data are included in the analysis. | Posted | | Mean | Standard Deviation | days | | At time of delivery (Up to 42 weeks' gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants Who Delivered Vaginally | This outcome was assessed in pregnant participants. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | At time of delivery (up to 42 weeks' gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants Who Delivered Via Operative Vaginal Birth | This outcome was assessed in pregnant participants. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | At time of delivery (up to 42 weeks' gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants Who Delivered Vaginally After a Prior Cesarean Section | This outcome was assessed in pregnant participants. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | At time of delivery (up to 42 weeks' gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants Who Delivered Via a Primary Cesarean Section | Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | At time of delivery (up to 42 weeks' gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants Who Delivered Via a Repeat Cesarean Section | This outcome was assessed in pregnant participants. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | At time of delivery (up to 42 weeks' gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| 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. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | At time of delivery (up to 42 weeks' gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| 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. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | At time of delivery (up to 42 weeks' gestation) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants With Post-partum Hemorrhage | This outcome was assessed in pregnant participants after delivery. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | Up to 6 weeks after delivery | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy | This outcome was assessed in pregnant participants. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | From time of GDM screen up to 6 weeks after delivery | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Length of Postnatal Stay From Delivery to Discharge | Average number of days admitted in the hospital after delivery up to discharge | Participants who had delivery data are included in the analysis. | Posted | | Mean | Standard Deviation | days | | Up to 1 week after delivery | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants Who Had a Postpartum Readmission | This outcome was assessed in pregnant participants post-delivery. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | From initial hospital discharge up to 6 weeks post-partum | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum | This outcome was assessed in pregnant participants after delivery. | Participants who had delivery data are included in the analysis. | Posted | | Count of Participants | | Participants | | From time of delivery up to 6 weeks post-partum | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Mean Neonatal Birthweight | | Participants with a live birth are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Day of delivery (Within approximately 2 hours after delivery) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Neonates With Birth Weight More Than 4000 Grams | | Participants with a live birth are included in the analysis. | Posted | | Number | | neonates | | Day of delivery (Within approximately 2 hours after delivery) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Neonates Considered Large for Gestational Age (LGA) | LGA refers to neonatal birth weight larger than the 90th percentile for gestational age. | Participants with a live birth are included in the analysis. | Posted | | Number | | neonates | | Day of delivery (Within approximately 2 hours after delivery) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Neonates Considered Small for Gestational Age (SGA) | SGA are infants whose weight is < the 10th percentile for gestational age. | Participants with a live birth are included in the analysis. | Posted | | Number | | neonates | | Day of delivery (Within approximately 2 hours after delivery) | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU) | | Participants with a live birth are included in the analysis. | Posted | | Number | | neonates | | Up to 28 days after delivery | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Neonates With Hyperbilirubinemia | | Participants with a live birth are included in the analysis. | Posted | | Number | | neonates | | Up to 28 days after delivery | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Neonates With Hypoglycemia | | Participants with a live birth are included in the analysis. | Posted | | Number | | neonates | | Up to 28 days after delivery | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Neonates Diagnosed With Respiratory Distress Syndrome | | Participants with a live birth are included in the analysis. | Posted | | Number | | neonates | | Up to 28 days after delivery | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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| Secondary | Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge | | Participants with breast feeding data are included in the analysis | Posted | | Number | | neonates | | Up to 28 days after delivery | | | | ID | Title | Description |
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| OG000 | Fasting Before Gestational Diabetes Screen | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Fasting before gestational diabetes screen: Fasting for at least 6 hours before 1-hour gestational diabetes screen. | | OG001 | Fed Before Gestational Diabetes Screen | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Per oral intake of food and drink: Per oral intake of food and drink within 2 hours of gestational diabetes screen |
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