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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one-hour Glucose tolerance test (GCT) | Active Comparator |
| |
| CGM screening | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1: one-hour GCT | Device | Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Neonates That Show Composite Adverse Neonatal Outcome | Composite adverse neonatal outcome include one or more of the following:
| From birth to about 28 days of life. |
| Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA) | LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al) | at time of birth |
| Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia | Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered | at time of birth |
| Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury | Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury | at time of birth |
| Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing | From enrollment to 6 weeks post partum, on average 21 weeks | |
| Number of Women That Use Diabetic Medication During Pregnancy | diabetic medication is described as any glycemic control agent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Fishel Bartal, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37088275 | Derived | Fishel Bartal M, Ashby Cornthwaite J, Ghafir D, Ward C, Nazeer SA, Blackwell SC, Pedroza C, Chauhan SP, Sibai BM. Continuous glucose monitoring in individuals undergoing gestational diabetes screening. Am J Obstet Gynecol. 2023 Oct;229(4):441.e1-441.e14. doi: 10.1016/j.ajog.2023.04.021. Epub 2023 Apr 23. |
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A total of 1,628 individuals (814 mother-infant dyads) were enrolled. Each mother was enrolled during pregnancy, prior to the birth of her infant. Following delivery, data collection continued for both mother and infant as part of the same dyad.
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM screening | Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
|
| FG001 | one-hour Glucose tolerance test (GCT) | Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Characteristics were not collected for infants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Screening | Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Neonates That Show Composite Adverse Neonatal Outcome | Composite adverse neonatal outcome include one or more of the following:
| Posted | Count of Participants | Participants | From birth to about 28 days of life. |
|
Mothers were assessed from enrollment up to 6 weeks post delivery, on average 21 weeks. Infants were assessed from birth up to 6 weeks post delivery, on average 6 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM screening: Infants | Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michal Fishel Bartal, MD | The University of Texas Health Science Center at Houston | 713-500-6421 | Michal.F.Bartal@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2023 | Jul 31, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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|
| Group 2: CGM placement | Device | CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
|
|
Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy
| from birth to discharge (about 3-15 days) |
| Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress | Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life | from birth to discharge (about 3-15 days) |
| Number of Fetal or Neonatal Deaths | within 28 days of birth |
| From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly | From enrollment to delivery |
| Number of Women That Have Preterm Birth | Pre term birth is described as delivery less than 37 weeks of gestation | at time of birth |
| Number of Women That Undergo Induced Labor | at time of birth |
| Number of Women That Experience Pregnancy Induced Hypertension | From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Women That Experience Eclampsia: Seizures | From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Women Admitted Due to Poor Glucose Control | From enrollment up to delivery |
| Number of Women With Primary Cesarean Section | at time of birth |
| Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml | From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Women With Endometritis | From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Women With Wound Complications | From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Women With Diagnosis of Type 2 Diabetes During Postpartum | birth to 6 weeks postpartum |
| Number of Neonates With Apgar Score Less Than 7 | The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome. | 5 minutes after birth |
| Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU) | birth to time of discharge from NICU (about 15 days) |
| NICU Length of Stay | birth to time of discharge from NICU (about 15 days) |
| Number of Neonates With Hyperbilirubinemia Requiring Phototherapy | birth to discharge (about 3-15 days) |
| Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy | birth to discharge (about 3-15 days) |
| Number of Neonates That Are Small for Gestational Age | Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al) | at time of birth |
| Number of Participants Who Breastfed Their Babies | from birth to 6 weeks postpartum |
| Number of Participants Who Formula Fed Their Babies | from birth to 6 weeks postpartum |
| Maximum Bilirubin Level - Neonates | birth to discharge (about 3 -15 days) |
| Cord Arterial pH | at time of birth |
| Number of Neonates With Polycythemia | birth to discharge (about 3 -15 days) |
| Number of Women That Experience Preeclampsia With Severe Features | From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Women That Experience Super Imposed Preeclampsia | From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Women With Need for Blood Transfusion | From enrollment to 6 weeks post partum, on average 21 weeks |
| Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester | Third trimester (≥28 weeks gestation through delivery) |
| Number of Women That Experience HELLP Syndrome | HELLP syndrome: a group of symptoms in pregnant women characterized by hemolysis (H), elevated liver enzymes (EL), and/or low platelet (LP) count, assessed according to ACOG guidelines. | From enrollment to 6 weeks post partum, on average 21 weeks |
| Cord Venous pH | at time of birth |
| Total Health System Costs for Mothers and Infants | From enrollment to 6 weeks post partum, on average 21 weeks |
| BG001 | One-hour Glucose Tolerance Test (GCT) | Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of maternal participants on government assisted insurance | Count of Participants | Participants |
|
| Number of maternal participants with Nulliparous | Nulliparous means never given birth before. | Count of Participants | Participants |
|
| Number of maternal participants with body mass index (BMI) greater than 30 at first prenatal visit | Count of Participants | Participants |
|
| Number of maternal participants with body mass index (BMI) greater than 40 | Count of Participants | Participants |
|
| Number of maternal participants with chronic hypertension | Count of Participants | Participants |
|
| Number of maternal participants with family history of diabetes mellitus | Count of Participants | Participants |
|
| Number of maternal participants with Gestational diabetes in previous pregnancy | Count of Participants | Participants |
|
| Gestational age at randomization | Mean | Standard Deviation | weeks |
|
| Number of maternal participants with Thyroid disease | Count of Participants | Participants |
|
| Number of maternal participants with tobacco use during pregnancy | Count of Participants | Participants |
|
| Number of maternal participants with Alcohol use during pregnancy | Count of Participants | Participants |
|
| Number of maternal participants with Substance use during pregnancy | Count of Participants | Participants |
|
| CGM screening |
Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
|
| OG001 | one-hour Glucose tolerance test (GCT) | Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above. |
|
|
| Primary | Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA) | LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al) | Posted | Count of Participants | Participants | at time of birth |
|
|
|
| Primary | Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia | Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered | Posted | Count of Participants | Participants | at time of birth |
|
|
|
| Primary | Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury | Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury | Posted | Count of Participants | Participants | at time of birth |
|
|
|
| Primary | Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia | Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy | Posted | Count of Participants | Participants | from birth to discharge (about 3-15 days) |
|
|
|
| Primary | Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress | Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life | Posted | Count of Participants | Participants | from birth to discharge (about 3-15 days) |
|
|
|
| Primary | Number of Fetal or Neonatal Deaths | Posted | Count of Participants | Participants | within 28 days of birth |
|
|
|
| Secondary | Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing | Data for this outcome measure were only collected for participants in the GCM screening arm. | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women That Use Diabetic Medication During Pregnancy | diabetic medication is described as any glycemic control agent | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly | Posted | Count of Participants | Participants | From enrollment to delivery |
|
|
|
| Secondary | Number of Women That Have Preterm Birth | Pre term birth is described as delivery less than 37 weeks of gestation | Posted | Count of Participants | Participants | at time of birth |
|
|
|
| Secondary | Number of Women That Undergo Induced Labor | Posted | Count of Participants | Participants | at time of birth |
|
|
|
| Secondary | Number of Women That Experience Pregnancy Induced Hypertension | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women That Experience Eclampsia: Seizures | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women Admitted Due to Poor Glucose Control | Posted | Count of Participants | Participants | From enrollment up to delivery |
|
|
|
| Secondary | Number of Women With Primary Cesarean Section | Posted | Count of Participants | Participants | at time of birth |
|
|
|
| Secondary | Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women With Endometritis | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women With Wound Complications | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women With Diagnosis of Type 2 Diabetes During Postpartum | Posted | Count of Participants | Participants | birth to 6 weeks postpartum |
|
|
|
| Secondary | Number of Neonates With Apgar Score Less Than 7 | The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome. | Posted | Count of Participants | Participants | 5 minutes after birth |
|
|
|
| Secondary | Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU) | Posted | Count of Participants | Participants | birth to time of discharge from NICU (about 15 days) |
|
|
|
| Secondary | NICU Length of Stay | Posted | Mean | Inter-Quartile Range | hours | birth to time of discharge from NICU (about 15 days) |
|
|
|
| Secondary | Number of Neonates With Hyperbilirubinemia Requiring Phototherapy | Posted | Count of Participants | Participants | birth to discharge (about 3-15 days) |
|
|
|
| Secondary | Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy | Posted | Count of Participants | Participants | birth to discharge (about 3-15 days) |
|
|
|
| Secondary | Number of Neonates That Are Small for Gestational Age | Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al) | Posted | Count of Participants | Participants | at time of birth |
|
|
|
| Secondary | Number of Participants Who Breastfed Their Babies | Posted | Count of Participants | Participants | from birth to 6 weeks postpartum |
|
|
|
| Secondary | Number of Participants Who Formula Fed Their Babies | Posted | Count of Participants | Participants | from birth to 6 weeks postpartum |
|
|
|
| Secondary | Maximum Bilirubin Level - Neonates | The study team decided that this outcome measure was not going to be collected therefore, the laboratory assays were not performed and no data were collected for this outcome. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision | Posted | birth to discharge (about 3 -15 days) |
|
|
| Secondary | Cord Arterial pH | Posted | Mean | Inter-Quartile Range | pH | at time of birth |
|
|
|
| Secondary | Number of Neonates With Polycythemia | Posted | Count of Participants | Participants | birth to discharge (about 3 -15 days) |
|
|
|
| Secondary | Number of Women That Experience Preeclampsia With Severe Features | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women That Experience Super Imposed Preeclampsia | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Women With Need for Blood Transfusion | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester | Posted | Count of Participants | Participants | Third trimester (≥28 weeks gestation through delivery) |
|
|
|
| Secondary | Number of Women That Experience HELLP Syndrome | HELLP syndrome: a group of symptoms in pregnant women characterized by hemolysis (H), elevated liver enzymes (EL), and/or low platelet (LP) count, assessed according to ACOG guidelines. | Posted | Count of Participants | Participants | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
|
| Secondary | Cord Venous pH | Data were not collected or analyzed for Cord Venous pH. The study team determined that collection of cord venous pH was not required based on academic evidence that a different marker, arterial pH, is a reliable marker. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision. Please see outcome #30 for data on arterial pH. | Posted | at time of birth |
|
|
| Secondary | Total Health System Costs for Mothers and Infants | Data were not collected or analyzed for this outcome because there was no standardized cost or charging across participants therefore there was no data to collect or analyze for any participants. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision | Posted | From enrollment to 6 weeks post partum, on average 21 weeks |
|
|
| 2 |
| 405 |
| 0 |
| 405 |
| 0 |
| 405 |
| EG001 | one-hour Glucose tolerance test (GCT): Infants | Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above. | 2 | 409 | 0 | 409 | 0 | 409 |
| EG002 | CGM screening: Mothers | Group 2: CGM placement: CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
| 0 | 405 | 0 | 405 | 0 | 405 |
| EG003 | one-hour Glucose tolerance test (GCT): Mothers | Group 1: one-hour GCT: Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above. | 0 | 409 | 0 | 409 | 0 | 409 |
Not provided
Not provided
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |