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Protocol - Gestational Diabetes

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Description:

This is a medical records abstraction form, which collects information on glucose screening, glucose tolerance testing, HgbA1c testing, and fasting glucose testing during pregnancy.

Specific Instructions:

If there are more test results available than indicated in Q1-4, enter first and last test results for questions 1-3. Enter first three and last results for Q4. If fewer results than requested are available in Q1-4, Enter "-8" for month and move to next question. The Pregnancy Working Group recommends referencing the World Health Organization (WHO), American Diabetes Association® (ADA), and American Congress of Obstetricians and Gynecologists (ACOG) for diagnostic criteria of gestational diabetes.

Protocol:

1. Glucose screen (50g challenge)

Test date a:

__ __/__ __/__ __ __ __

result: a1: __ __ __. __ mg/dL

m m / d d / y y y y

Test date b:

__ __/__ __/__ __ __ __

result: b1: __ __ __. __ mg/dL

m m / d d / y y y y

01[ ]not done

2. Glucose tolerance testing (3-hr GTT, 100g challenge)

Test date a:

__ __/__ __/__ __ __ __

m m / d d / y y y y

Fasting Blood Sugar (FBS):

a0: __ __ __. __ mg/dL

1-hr: a1: __ __ __. __ mg/dL

2-hr: a2: __ __ __. __ mg/dL

3-hr: a3: __ __ __. __ mg/dL

Test date b:

__ __/__ __/__ __ __ __

m m / d d / y y y y

FBS: b0: __ __ __. __ mg/dL

1-hr: b1: __ __ __. __ mg/dL

2-hr: b2: __ __ __. __ mg/dL

3-hr: b3: __ __ __. __ mg/dL

01[ ]not done

3. Glucose tolerance testing (2-hr GTT, 75g challenge)

Test date a:

__ __/__ __/__ __ __ __

m m / d d / y y y y

FBS: a0: __ __ __. __ mg/dL

1-hr: a1: __ __ __. __ mg/dL

2-hr: a2: __ __ __. __ mg/dL

Test date b:

__ __/__ __/__ __ __ __

m m / d d / y y y y

FBS: b0: __ __ __. __ mg/dL

1-hr: b1: __ __ __. __ mg/dL

2-hr: b2: __ __ __. __ mg/dL

01[ ]not done

4. HgbA1c test - test date and result

m m / d d / y y y y

Result

a) __ __ / __ __ / __ __ __ __

a1) __ __. __ %

b) __ __ / __ __ / __ __ __ __

b1) __ __. __ %

c) __ __ / __ __ / __ __ __ __

c1) __ __. __ %

d) __ __ / __ __ / __ __ __ __

d1) __ __. __ %

5. During this pregnancy, was a fasting plasma glucose result > 92 mg/dL obtained at any gestational age BEFORE meeting the criteria for a diabetes diagnosis?

1[ ]NA, Type 1 or Type II diabetes before pregnancy (End questionnaire)

2[ ]Yes……………………………………………………. (Continue to Q5 a)

3[ ]No……………………………………………………... (Skip to Q6)

4[ ]Not done/none recorded…………………………….(Skip to Q6)

IF YES:

  1. Provide the value and date of the two highest fasting plasma glucose results ≥ 92 mg/dL from two separate dates during this pregnancy before a diagnosis of diabetes.

m m / d d / y y y y

1) __ __ __. __ mg/dL

__ __/__ __/__ __ __ __

2) __ __ __. __ mg/dL

__ __/__ __/__ __ __ __

c) No 2nd value ☐

6. During this pregnancy, was a random (non-fasting) plasma glucose result > 200 mg/dL obtained at any gestational age BEFORE meeting the criteria for a diabetes diagnosis?

2[ ]Yes……………………………………………………. (Continue to Q6 a)

3[ ]No……………………………………………………... (End questionnaire)

4[ ]Not done/none recorded…………………………… (End questionnaire)

IF YES:

a) Provide the value and date of the two highest fasting plasma glucose results ≥ 200 mg/dL from two separate dates during this pregnancy before a diagnosis of diabetes.

a) Random plasma glucose result b) Date of test

m m / d d / y y y y

3) __ __ __. __ mg/dL

__ __/__ __/__ __ __ __

4) __ __ __. __ mg/dL

__ __/__ __/__ __ __ __

c) No 2nd value ☐

Protocol Name from Source:

Nulliparous Pregnancy Outcomes Study Monitoring Mothers-to-Be (nuMoM2b): CLA Prenatal Labs

Availability:

Publicly available

Personnel and Training Required

None

Equipment Needs

None

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Medical record abstraction

Life Stage:

Adolescent, Adult, Pregnancy

Participants:

Pregnant women with first pregnancy

Selection Rationale

The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b) is a major prospective cohort study collecting data from the first trimester of pregnancy through the end of pregnancy on approximately 10,000 nulliparous women. The protocols, consent forms, and data collection instruments were developed by the nuMoM2b investigators in collaboration with Project Scientists from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and vetted by an independent Advisory and Safety Monitoring Board reporting to NICHD.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Chart Abstraction Gestational Diabetes Assessment Assessment Text 5633908 CDE Browser
Derived Variables

None

Process and Review

Not applicable.

Source

Nulliparous Pregnancy Outcomes Study Monitoring Mothers-to-Be (nuMoM2b): CLA Prenatal Labs, Version 04, March 22, 2013

General References

American Congress of Obstetricians and Gynecologists (ACOG). (2011). Committee opinion no. 504: Screening and diagnosis of gestational diabetes mellitus. Obstetrics and Gynecology, 118, 751-753.

DeSisto, C. L., Kim, S. Y., & Sharma, A. J. (2014). Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Preventing Chronic Disease, 11, E104.

Protocol ID:

241001

Variables:
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX241001_Gestational_Diabetes_Fasting_Plasma_Glucose_Test_A_Date
PX241001060101 Fasting plasma glucose - Test A: Date N/A
PX241001_Gestational_Diabetes_Fasting_Plasma_Glucose_Test_A_Result
PX241001060102 Fasting plasma glucose - Test A: Result N/A
PX241001_Gestational_Diabetes_Fasting_Plasma_Glucose_Test_B_Date
PX241001060201 Fasting plasma glucose - Test B: Date N/A
PX241001_Gestational_Diabetes_Fasting_Plasma_Glucose_Test_B_Result
PX241001060202 Fasting plasma glucose - Test B: Result N/A
PX241001_Gestational_Diabetes_Glucose_Result_Before_Diagnosis
PX241001050000 During this pregnancy, was a fasting plasma more
glucose result > 92 milligram per deciliter obtained at any gestational age BEFORE meeting the criteria for a diabetes diagnosis? show less
N/A
PX241001_Gestational_Diabetes_Glucose_ScreenA_Date
PX241001010101 Glucose screen (50g challenge) - Test A: date N/A
PX241001_Gestational_Diabetes_Glucose_ScreenA_Result
PX241001010102 Glucose screen (50g challenge) - Test A: Result N/A
PX241001_Gestational_Diabetes_Glucose_ScreenB_Date
PX241001010201 Glucose screen (50g challenge) - Test B: date N/A
PX241001_Gestational_Diabetes_Glucose_ScreenB_Result
PX241001010202 Glucose screen (50g challenge) - Test B: Result N/A
PX241001_Gestational_Diabetes_Glucose_Screen_Other
PX241001010300 Glucose screen (50g challenge): Other N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Date
PX241001020100 Glucose tolerance testing (a3 (3-hr) GTT, more
100g challenge): Date show less
N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Other
PX241001020304 Glucose tolerance testing (a3 (3-hr) GTT, more
100g challenge): Other show less
N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Test_A_Baseline
PX241001020201 Fasting Blood Sugar (FBS) - Test A: a0 N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Test_A_Hour_1
PX241001020202 Fasting Blood Sugar (FBS) - Test A: a1 (1-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Test_A_Hour_2
PX241001020203 Fasting Blood Sugar (FBS) - Test A: a2 (2-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Test_A_Hour_3
PX241001020204 Fasting Blood Sugar (FBS) - Test A: a3 (3-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Test_B_Baseline
PX241001020205 Fasting Blood Sugar (FBS) - Test B: b0 N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Test_B_Hour_1
PX241001020301 Fasting Blood Sugar (FBS) - Test B: b1 (1-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Test_B_Hour_2
PX241001020302 Fasting Blood Sugar (FBS) - Test B: b2 (2-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_100g_Test_B_Hour_3
PX241001020303 Fasting Blood Sugar (FBS) - Test B: b3 (3-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_75g_Date
PX241001030100 Glucose tolerance testing (a2 (2-hr) GTT, more
75g challenge): Date show less
N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_75g_Other
PX241001030400 Glucose tolerance testing (a3 (2-hr) GTT, more
75g challenge): Other show less
N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_75g_Test_A_Baseline
PX241001030201 Fasting Blood Sugar (FBS) - Test A: a0 N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_75g_Test_A_Hour_1
PX241001030202 Fasting Blood Sugar (FBS) - Test A: a1 (1-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_75g_Test_A_Hour_2
PX241001030203 Fasting Blood Sugar (FBS) - Test A: a2 (2-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_75g_Test_B_Baseline
PX241001030301 Fasting Blood Sugar (FBS) - Test B: b0 N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_75g_Test_B_Hour_1
PX241001030302 Fasting Blood Sugar (FBS) - Test B: b1 (1-hr) N/A
PX241001_Gestational_Diabetes_Glucose_Tolerance_75g_Test_B_Hour_2
PX241001030303 Fasting Blood Sugar (FBS) - Test B: b2 (2-hr) N/A
PX241001_Gestational_Diabetes_HgbA1_TestC_Date
PX241001040301 HgbA1c test - Test C: Date N/A
PX241001_Gestational_Diabetes_HgbA1_TestC_Percentage
PX241001040302 HgbA1c test - Test C: Percentage N/A
PX241001_Gestational_Diabetes_HgbA1_TestD_Date
PX241001040401 HgbA1c test - Test D: Date N/A
PX241001_Gestational_Diabetes_HgbA1_TestD_Percentage
PX241001040402 HgbA1c test - Test D: Percentage N/A
PX241001_Gestational_Diabetes_HgbA1_Test_A_Date
PX241001040101 HgbA1c test - Test A: Date N/A
PX241001_Gestational_Diabetes_HgbA1_Test_A_Percentage
PX241001040102 HgbA1c test - Test A: Percentage N/A
PX241001_Gestational_Diabetes_HgbA1_Test_B_Date
PX241001040201 HgbA1c test - Test B: Date N/A
PX241001_Gestational_Diabetes_HgbA1_Test_B_Percentage
PX241001040202 HgbA1c test - Test B: Percentage N/A
Pregnancy
Measure Name:

Gestational Diabetes

Release Date:

January 31, 2017

Definition

Abstraction of prenatal laboratory data to determine if the woman may have gestational diabetes.

Purpose

This measure is used to assess if a woman has gestational diabetes. Pregnant women are commonly screened for diabetes because untreated or poorly controlled gestational diabetes can cause negative health outcomes for the mother and baby, including macrosomia, hypoglycemia, and respiratory distress syndrome, as well as increased risk for cesarean section delivery.

Keywords

Pregnancy, pregnancy complications, glucose tolerance testing, GTT, glucose screen, glycosylated hemoglobin, HgbA1c, fasting plasma glucose, nuMoM2b