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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.

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

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.

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
Process and Review

The Expert Review Panel has not reviewed this measure yet.

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 NameVariable IDVariable DescriptionVersiondbGaP Mapping
Research Domain Information
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