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Our study will assess if there is a difference in incidence of gestational diabetes using different screening approaches, either using a one-step approach with a 2 hour glucose tolerance test or using a two-step approach. Prior studies have proven similar incidences including a randomized controlled trial.
Gestational Diabetes is screened for in pregnancy by drinking a solution containing a certain amount of glucose and testing blood glucose level one hour after drinking it. If this value is above a certain cut-off (>135mg/dl), the patient is subjected to another test involving drinking a solution containing a higher amount of glucose and checking blood glucose while fasting, 1 hour after drinking the solution and 2 hours after drinking the solution. (Two step approach).
Cut off values will be: 3 hour>180 mg/dl, 2 hour > 155 mg/dl, 1hour >140 mg/dl, fasting >95mg/dl. Two abnormal values will meet the diagnosis of gestational diabetes.
In other parts of the United States, and most of the rest of the word, screening for gestational diabetes uses a one-step approach by drinking a solution containing 75g of glucose (As recommended by the American Diabetic Society, the Endocrine Society, WHO and the International Association of Diabetes and Pregnancy Study groups1-3). Blood glucose values are checked at fasting, one hour and two hours after solution drinking.
The diagnosis of gestational diabetes is based on one elevated values. (cut off: Fasting ≥92mg/dl, 1hour ≥180 mg/dl, 2 hours ≥153 mg/dl).
Our study will assess if there is a difference in incidence of gestational diabetes using these different screening approaches. Prior studies have proven similar incidences including a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One Step | Experimental | The intervention is gestational diabetes screening with 2 hour GTT 75 g load. |
|
| Two Step | Active Comparator | There is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDM screening with 75 g 2 hour GTT | Diagnostic Test | Patients will be diagnosed with gestational diabetes if they have one abnormal value: Fasting ≥ 92; 2 hour ≥ 180 mg/dl;1 hour ≥ 153 mg/dl. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of gestational diabetes diagnosed on each screening test of each arm. | Gestational diabetes will be made based on one abnormal value. Fasting ≥126 mg/dl; 1 hour≥ 180 mg/dl and 2 hour ≥ 153 mg/dl | at the time of the screening |
| Measure | Description | Time Frame |
|---|---|---|
| neonatal hyperbilirubinemia | incidence of neonatal hyperbilirubinemia | first 48 hours of life |
| mode of delivery | incidence of cesarean delivery, spontaneous vaginal delivery, operative vaginal delivery, and induction of labor |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women (limits the participants to female gender)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeeb Khalifeh, MD | Contact | adeeb.khalifeh@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adeeb Khalifeh | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12081977 | Result | Southwick AM, Wang LX, Long SR, Lee YC. Activity of Sinorhizobium meliloti NodAB and NodH enzymes on thiochitooligosaccharides. J Bacteriol. 2002 Jul;184(14):4039-43. doi: 10.1128/JB.184.14.4039-4043.2002. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 22, 2021 | |
| Reset | Dec 20, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 22, 2021 | Dec 20, 2021 |
| 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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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| GDM screening with two step approach | Diagnostic Test | 1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive |
|
| at time of delivery |
| gestational age at delivery | gestational age at delivery | at time of delivery |
| Anal sphincter injury | Incidence of Anal sphincter injury | at time of delivery |
| Shoulder dystocia | incidence of shoulder dystocia, and birth trauma | at time of delivery |
| Neonatal complications | includes necrotizing enterocolitis, respiratory distress syndrome, intraventricular hemorrhage, hypoglycemia, jaundice, hyperbilirubinemia, perinatal death, admission to neonatal intensive care unit | between birth and 28 days of age |
| Hypertensive disorders in pregnancy | includes gestational hypertension, preeclampsia | 6 months |
| Fetal growth restriction, large for gestational age and polyhydramnios | Incidence of Fetal growth restriction,large for gestational age and polyhydramnios | 6 months |
| Birth weight | Mean of birth weight and incidence of macrosomia | Time of delivery |
| Apgar score | Apgar score | at 1, 5 and 10 minutes after birth |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |