Protocol - Gestational Diabetes

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.

Availability

Available

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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:

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 2^nd 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 2^nd value ☐

Personnel and Training Required

None

Equipment Needs

None

Requirements

Requirement Category	Required
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

Lifestage

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

Standard	Name	ID	Source
Human Phenotype Ontology	Maternal diabetes	HP:0009800	HPO
caDSR Form	PhenX PX241001 - Gestational Diabetes Chart Abstraction	6889289	caDSR Form

Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

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

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 ID	Variable Description	dbGaP 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

Measure Protocols

Protocol ID	Protocol Name
241001	Gestational Diabetes

Publications

Chia, A. R., et al. (2020) Maternal plasma metabolic markers of neonatal adiposity and associated maternal characteristics: The GUSTO study. Scientific Reports. 2020 June; 10(1). doi: 10.1038/s41598-020-66026-5

Protocol - Gestational Diabetes

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Description

Specific Instructions

Availability

Protocol

Personnel and Training Required

Equipment Needs

Requirements

Mode of Administration

Lifestage

Participants

Selection Rationale

Language

Standards

Derived Variables

Process and Review

Protocol Name from Source

Source

General References

Protocol ID

Variables

Measure Name

Release Date

Definition

Purpose

Keywords

Measure Protocols

Publications