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U.S. Preventive Services Task Force (USPSTF)

Screening for Gestational Diabetes Mellitus

A Systematic Review for the U.S. Preventive Services Task Force

Appendix 2. Inclusion Criteria a

Key Question 1

  1. Study evaluates screening for gestational diabetes < 24 wk or > 24 wk in a population relevant to primary care.
  2. Acceptable screening methods: 1-step (75 g or 100 g); 2-step (50 g/100 g; 50 g/75 g); fasting glucose for < 24 wk.
  3. Positive result on screening includes:
    1. 50 g: glucose value > 130 mg/dL or > 140 mg/dL.
    2. 75 g: Carpenter and Coustan, ADA, or WHO criteria.
    3. 100 g: Carpenter and Coustan or NDDG criteria.
  4. Primary outcomes systematically identified.
    1. Maternal: mortality; preeclampsia/pregnancy-induced hypertension.
    2. Perinatal outcomes: mortality; brachial plexus injury; fractured clavicle; admission to NICU for treatment of hypoglycemia, hyperbilirubinemia, or the respiratory distress syndrome.
    3. Secondary or intermediate outcomes (not systematically included): macrosomia; cesarean section; induction of labor; preterm birth; maternal third- or fourth-degree perineal lacerations.
  5. Study design: RCT, CCT, or prospective cohort if no RCT available.

Key Question 2

  1. Study evaluates screening test sensitivity, specificity, reliability, and yield.
  2. Acceptable screening methods: 1-step (75 g or 100 g); 2-step (50 g/100 g; 50 g/75 g); fasting glucose for < 24 wk.
  3. Positive result on screening includes:
    1. 50 g: glucose value > 130 mg/dL or > 140 mg/dL.
    2. 75 g: Carpenter and Coustan, ADA, or WHO criteria.
    3. 100 g: Carpenter and Coustan or NDDG criteria.
  4. Outcomes: sensitivity, specificity, reliability, and yield.
  5. Study design: RCT, CCT, observational.
  6. Uses sensitivity and specificity criteria to assess primary health outcomes specified in the analytic framework.

Key Question 3

  1. Study evaluates treatment of gestational diabetes, including glyburide, any sulfonylurea, metformin, insulin, diet, and/or exercise therapy.
  2. Acceptable screening methods: 1-step (75 g or 100 g); 2-step (50 g/100 g; 50 g/75 g); fasting glucose for < 24 wk.
  3. Positive result on screening includes:
    1. 50 g: glucose value > 130 mg/dL or > 140 mg/dL.
    2. 75 g: Carpenter and Coustan, ADA, or WHO criteria.
    3. 100 g: Carpenter and Coustan or NDDG criteria.
  4. Primary outcomes systematically identified:
    1. Maternal: mortality; preeclampsia/pregnancy-induced hypertension.
    2. Perinatal outcomes: mortality; brachial plexus injury; fractured clavicle; admission to NICU for treatment of hypoglycemia, hyperbilirubinemia, or the respiratory distress syndrome.
    3. Secondary or intermediate outcomes (not systematically identified): macrosomia; cesarean section; preterm birth; maternal third- or fourth-degree perineal lacerations.
  5. Study design: RCT, CCT, or prospective cohort if no RCT available.

Key Question 4

  1. Study presents harms of screening tests accepted in key questions 1 or 3.
  2. Acceptable screening methods: 1-step (75 g or 100 g); 2-step (50 g/100 g; 50 g/75 g); fasting glucose for < 24 wk.
  3. Positive result on screening includes:
    1. 50 g: glucose value > 130 mg/dL or > 140 mg/dL.
    2. 75 g: Carpenter and Coustan, ADA, or WHO criteria.
    3. 100 g: Carpenter and Coustan or NDDG criteria.
    4. Exception allowed if used an accepted screening method and nonstandard cutoff criteria.
  4. Study design: all considered.

Key Question 5

  1. Study presents harms of treatment accepted in key question 3.
  2. Acceptable screening methods: 1-step (75 g or 100 g); 2-step (50 g/100 g; 50 g/75 g); fasting glucose for < 24 wk.
  3. Positive result on screening includes:
    1. 50 g: glucose value > 130 mg/dL or > 140 mg/dL.
    2. 75 g: Carpenter and Coustan, ADA, or WHO criteria.
    3. 100 g: Carpenter and Coustan or NDDG criteria.
    4. Exception allowed if used an accepted screening method and nonstandard cutoff criteria.
  4. Study design: all considered.

Exclusion Criteria

  1. Not an acceptable study design, including method of accepted study types or mixing gestational diabetes/impaired glucose tolerance/normal groups.
  2. Not generalizable to U.S. population.
  3. Did not address specified conditions and/or mortality.
  4. Not 1 of established screening criteria used (hemoglobin A1c), or 50-g OGTT used as a diagnostic test (nonstandard) or 75-/100-g or 100-g OGTT diagnostic tests using different diagnostic criteria than the current standards as outlined in our workplan (e.g., cutoffs plus SD to a different population mean).
  5. No information on yield (prevalence), sensitivity, specificity, or reliability.
  6. Not 1 of established screening criteria used (e.g., hemoglobin A1c).
  7. Not 1 of the included treatments for gestational diabetes (e.g., thiazolidinediones).
  8. Editorials, comments, and letters.
  9. Nonsystematic reviews.
  10. Did not address 1 of the key questions.
  11. Systematic review, but search strategy too old to be relevant for our interval update of the USPSTF 2003 gestational diabetes review.
  12. SER used as source document.
  13. Prevalence outside United States.
  14. Prevalence-only articles.
  15. Natural history–only articles.
  16. Did not report sensitivity and specificity criteria to assess specified health outcomes in the analytic framework.
  17. Poor quality.

a  To convert glucose values in mg/dL to mmol/L, multiply by 0.05551. ADA 5 American Diabetes Association; CCT 5 clinical controlled trial; NDDG 5 National Diabetes Data Group; NICU 5 neonatal intensive care unit; OGTT 5 oral glucose tolerance test; RCT 5 randomized, controlled trial; SER 5 systematic evidence review; USPSTF 5 U.S. Preventive Services Task Force; WHO 5 World Health Organization.

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