General Information

RecAbstr

Page 1 of 35 Data Entry Done Affix label here Participant ID

HAPO STUDY MEDICAL RECORD ABSTRACTION FORM

NOTE: Prior to abstraction, obtain the following information from the OGTT Visit Form:

OGTT visit date: 200 __ / __ __ / __ __ Urine protein dipstick result: ______

BP1: ______/ ______BP2: ______/ ______

OGTT visit date: 200 __ / __ __ / __ __ Urine protein dipstick result: ______

BP1: ______/ ______BP2: ______/ ______

NOTE: If there was a maternal or fetal death and delivery was never performed or delivery occurred elsewhere, contact the Data Coordinating Center for further instructions about medical record abstraction. Do NOT begin abstraction until you have obtained further instructions.

RE-ABSTRACTION

0. Is this a re-abstraction? CHECK ONLY ONE BOX Yes 1 No 2

ESSENTIAL DATA

1. Are these essential data available for abstraction? CHECK “YES” OR “NO” FOR EACH a. Birthweight Yes (or fetal death) 1 No 2

b. Labor and delivery records Yes 1 No 2

If “No” for either, STOP-Complete Study Conclusion Form

EXCLUSIONARY DATA

2. Were either of the following exclusion criteria present? CHECK “YES” OR “NO” FOR EACH a. Delivery occurred elsewhere Yes 1 No 2

b. Multiple pregnancy Yes 1 No 2

If “Yes” for either, STOP-Complete Study Conclusion Form

Medical Record Abstraction Form-June-28-00 RecAbstr

Page 2 of 35 Data Entry Done Affix label here Participant ID

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3. Was this participant’s glucose level unblinded because a HAPO threshold was met? CHECK ONLY ONE BOX (SKIP to Question 5) Yes 1 No 2

4. Were any blood glucose levels reported prior to delivery? CHECK ONLY ONE BOX

STOP-Complete Study Conclusion Form, Medical Record Glucose Value Form Yes 1 No 2

PRENATAL DATA First Prenatal Visit

5. a. First prenatal blood pressure: ______/ ______mmHg

b. Date of first prenatal blood pressure: ______/ __ __ / __ __ Year Mo Day

6. a. First prenatal weight: CHECK ONLY ONE  BOX AND ENTER THE VALUE  kg 1 lb 2 (SKIP to Question 7) Not recorded 3

______. __ __

b. Date of first prenatal weight: ______/ __ __ / __ __ Year Mo Day

7. a. First prenatal urine protein dipstick result: CHECK ONLY ONE BOX   Negative 1 Trace 2 (30 mg/dL or 0.30 g/L) 1+ 3 (100 mg/dL or 1 g/L) 2+ 4 (300 mg/dL or 3g/L) 3+ 5 (> 2000 mg/dL or > 20 g/L) 4+ 6 (SKIP to next section) No result 7

b. Date of first prenatal urine protein result: ______/ __ __ / __ __ Year Mo Day

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Past Obstetric History

8. Any previous pregnancies? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

9. Total number pregnancies, including current pregnancy (gravida/gravidity): __ __

10. Total number of prior Cesarean section deliveries: __ __

11. Total number of pregnancies delivered at > 20 weeks (parity): __ __

12. Total number of pregnancies delivered at > 37 weeks: __ __

13. Were there any pregnancies that ended prior to livebirth? Yes 1 (SKIP to Question 15) No 2

14. Total number of pregnancies that ended prior to livebirth:

a. < 20 weeks __ __

b. 20-27 weeks __ __

c. 28-32 weeks __ __

d. > 32 weeks-term __ __

e. Gestational age unknown __ __

15. Total number of neonatal deaths (within 28 days of livebirth): __ __

Illicit Drug Use

16. Any notation that the woman has used street/illicit drugs such as cocaine, LSD, heroin, marijuana, or inhaled solvents/gases since becoming pregnant this time? CHECK ONLY ONE BOX Yes 1 No 2

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Maternal Hematologic Indices

17. What was the first hemoglobin (Hgb or Hb) result? CHECK ONLY ONE BOX AND ENTER THE VALUE  mg/dL 1 umol/L 2 g/dL or g% 3 g/L 4 (SKIP to Question 19) No report 5

______. __ __

18. Date of first hemoglobin: ______/ __ __ / __ __ Year Mo Day

19. What was the first hematocrit (Hct or PCV) result: CHECK ONLY ONE BOX AND ENTER THE VALUE % or per 100 1 Proportion of 1.0 2 (SKIP to next section) No report 3

__ __ . ______

20. Date of first hematocrit: ______/ __ __ / __ __ Year Mo Day

Amniocentesis for Fetal Lung Maturity

21. Report of amniocentesis for fetal lung maturity? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

22. Date of most recent amniocentesis for fetal lung maturity: 2 0 0 __ / __ __ / __ __ Year Mo Day

23. Result of most recent amniocentesis for fetal lung maturity: CHECK ONLY ONE BOX-REFER TO LOCAL HAPO INVESTIGATOR IF REPORTED ONLY AS A NUMBER Mature 1 Transitional/Borderline 2 Not mature/Immature 3

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Amniotic Fluid Volume

24. How was amniotic fluid volume determined? CHECK ONLY ONE BOX

Ultrasound report 1 Clinical estimate 2 (SKIP to next section) No report 3

25. Date of most recent (latest in pregnancy) amniotic fluid volume: 2 0 0 __/ __ __ / __ __ Year Mo Day

26. Amniotic fluid volume: CHECK ONLY ONE BOX Normal 1 Oligohydramnios 2 Polyhydramnios 3

27. Amniotic fluid index (AFI): CHECK ONLY ONE BOX AND ENTER THE VALUE cm 1 mm 2 (SKIP to Question 28) No report 3

______. __

28. Deepest pool: CHECK ONLY ONE BOX AND ENTER THE VALUE cm 1 (SKIP to next section) No report 2

__ __ . __

Urinary Tract Infection

29. Any notation of prenatal diagnosis of urinary tract infection (UTI), pyelonephritis, kidney infection, cystitis, or positive urine culture? CHECK ONLY ONE BOX Yes 1 No 2

Transmissible Infections

30. Was the woman diagnosed with HIV during this pregnancy? CHECK ONLY ONE BOX (NOTIFY Central Laboratory) Yes 1 No 2

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31. Was the woman diagnosed with Hepatitis B during this pregnancy? CHECK ONLY ONE BOX

(NOTIFY Central Laboratory) Yes 1 No 2

32. Was the woman diagnosed with Hepatitis C during this pregnancy? CHECK ONLY ONE BOX

(NOTIFY Central Laboratory) Yes 1 No 2

Admission Prior to Delivery

33. Any hospitalizations prior to delivery admission? CHECK ONLY ONE BOX Yes 1 No 2

34. Any admission for a reason other than delivery which resulted in delivery? CHECK ONLY ONE BOX Yes 1 No 2 (If there were no hospitalizations prior to delivery and no hospital admissions for a reason other than delivery which resulted in delivery, SKIP to the next section)

35. Total number of hospital admissions (prior to delivery admission + an admission for another reason which resulted in delivery): __ __

36. Total number of days of hospitalization prior to delivery: ______

37. Any admission or transfer to a unit providing intensive care prior to delivery? CHECK ONLY ONE BOX

(Complete an Outcome Review Form - Maternal) Yes 1 No 2

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38. Indication(s) for admission(s) prior to or resulting in delivery: CHECK “YES” OR “NO” FOR EACH

a. Pre-eclampsia/hypertension Yes 1 No 2

b. Threatened preterm labor or preterm labor Yes 1 No 2

c. Infection Yes 1 No 2

d. Antepartum hemorrhage (abruption or previa) Yes 1 No 2

e. Major maternal injury Yes 1 No 2

f. Severe asthma Yes 1 No 2

g. Diabetic control Yes 1 No 2

h. Hyperemesis Yes 1 No 2

i. Observation for decreased fetal movement Yes 1 No 2

j. Premature rupture of membranes Yes 1 No 2

k. Polyhydramnios Yes 1 No 2

l. Other Yes 1 No 2 (If “Other”, please specify: ______)

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Medications

39. Were any of the following medications used (orally, subcutaneously, or parenterally) antepartum prior to admission for delivery? CHECK “YES” OR “NO” FOR EACH

a. ß-mimetics Yes 1 No 2

b. Corticosteroids Yes 1 No 2

c. Antibiotics Yes 1 No 2

Last Prenatal Weight

40. a. Last prenatal weight: CHECK ONLY ONE BOX AND ENTER THE VALUE kg 1 lb 2

______. __ __

b. Date of last prenatal weight: 2 0 0 __ / __ __ / __ __ Year Mo Day

MATERNAL OUTCOMES Pregnancy-Induced Hypertension

41. Any notation of diagnosis of hypertension/toxemia/pre-eclampsia/ eclampsia/pregnancy-induced hypertension? CHECK ONLY ONE BOX

(If eclampsia-Complete an Outcome Review Form – Maternal) Yes 1 (SKIP to Question 45) No 2

42. Date first diagnosed: ______/ __ __ / __ __ Year Mo Day

43. Was medication prescribed during pregnancy for the treatment of hypertension/toxemia/pre-eclampsia/eclampsia/pregnancy-induced hypertension (in a woman not on medication prior to pregnancy)? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 45) No 2

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44. When during pregnancy was medication first prescribed? ______/ __ __ / __ __ Year Mo Day

45. Any systolic blood pressure > 140 mmHg AND/OR diastolic blood pressure > 90 mmHg (including OGTT visit)? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 58) No 2

46. Value of the first elevated blood pressure reading: ______/ ______mmHg

47. Date of the first elevated blood pressure reading: ______/ __ __ / __ __ Year Mo Day

48. Urine protein dipstick result on this date: CHECK ONLY ONE BOX  Negative 1 Trace 2 (30 mg/dL or 0.30 g/L) 1+ 3 (100 mg/dL or 1 g/L) 2+ 4 (300 mg/dL or 3g/L) 3+ 5 (> 2000 mg/dL or > 20 g/L) 4+ 6 No result 7

49. Was there another systolic blood pressure > 140 mmHg AND/OR diastolic blood pressure > 90 mmHg (including OGTT visit)? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 58) No 2

50. Value of the second elevated blood pressure reading: ______/ ______mmHg

51. Date of the second elevated blood pressure reading: ______/ __ __ / __ __ Year Mo Day

52. Were the first and second elevated readings obtained at least 6 hours apart? CHECK ONLY ONE BOX

(SKIP to Question 55) Yes 1 No 2 Unknown 3

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53. Next elevated blood pressure recorded at least 6 hours after first elevated blood pressure: ______/ ______mmHg

54. Date of next elevated blood pressure reading: ______/ __ __ / __ __ Year Mo Day

55. Was there a systolic blood pressure > 160 mmHg AND/OR diastolic blood pressure > 110 mmHg (including OGTT visit)? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 58) No 2

56. Value of the earliest blood pressure reading with systolic > 160 mmHg and/or diastolic > 110 mmHg: ______/ ______mmHg

57. Date of this elevated blood pressure reading: ______/ __ __ / __ __ Year Mo Day

58. Was there a urine protein dipstick result > 1+ (> 30 mg/dL or 0.30 g/L)? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 63) No 2

59. Value of first urine protein dipstick result > 1+: CHECK ONLY ONE BOX   (30 mg/dL or 0.30 g/L) 1+ 1 (100 mg/dL or 1 g/L) 2+ 2 (300 mg/dL or 3 g/L) 3+ 3 (> 2000 mg/dL or > 20 g/L) 4+ 4

60. Date of first urine protein dipstick result > 1+: ______/ __ __ / __ __ (> 30 mg/dL or 0.30 g/L) Year Mo Day

61. Highest urine protein dipstick result: CHECK ONLY ONE BOX   (30 mg/dL or 0.30 g/L) 1+ 1 (100 mg/dL or 1 g/L) 2+ 2 (300 mg/dL or 3 g/L) 3+ 3 (> 2000 mg/dL or > 20 g/L) 4+ 4

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62. Date of first highest urine protein dipstick result: ______/ __ __ / __ __ Year Mo Day

63. Any 24-hour urine collection for protein? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 67) No 2

64. Any proteinuria result > 300 mg (0.3 g)/24 hours? CHECK ONLY ONE BOX

Yes 1 (SKIP to Question 67) No 2

65. Highest proteinuria result > 300 mg (0.3g)/24 hours: ______mg/24 hours

66. Date of this urine collection: ______/ __ __ / __ __ Year Mo Day

67. Any elevated protein/creatinine ratio result? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 71) No 2

68. Date of first elevated protein/creatinine ratio result: ______/ __ __ / __ __ Year Mo Day

69. Any protein/creatinine ratio result equivalent to > 5 g on a 24-hour urine collection? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 71) No 2

70. Date of the first urine protein/creatinine ratio result ______/ __ __ / __ __ equivalent to > 5 g on a 24-hour urine collection: Year Mo Day

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71. Any report or notation of any of the following? CHECK “YES” OR “NO” FOR EACH

a. Urine output < 500 ml/24 hours Yes 1 No 2

b. Elevated serum transaminase Yes 1 No 2

c. Platelet count < 100,000 Yes 1 No 2

72. Any notation or diagnosis of any of the following? CHECK “YES” OR “NO” FOR EACH a. Grand mal seizures Yes 1 No 2

b. Pulmonary edema Yes 1 No 2

c. HELLP Syndrome Yes 1 No 2

d. Epigastric pain Yes 1 No 2

e. Blurred vision Yes 1 No 2

f. Headache Yes 1 No 2

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LABOR AND DELIVERY DATA Type of Delivery

73. Date of admission to labor/delivery unit: 2 0 0 __ / __ __ / __ __ Year Mo Day

74. Time of admission to labor/delivery unit: __ __ : __ __

75. Type of delivery: CHECK ONLY ONE BOX

Spontaneous vaginal delivery 1 Outlet or lift out forceps/vacuum extraction or low forceps/vacuum 2 Mid forceps/vacuum 3 Spontaneous or assisted breech extraction 4 Total breech extraction 5 Internal version and breech extraction 6 Primary (first) cesarean section 7 Repeat cesarean section 8 Unknown 9

(If Cesarean, go to Question 76, otherwise SKIP to next section)

76. Type of cesarean section: CHECK ONLY ONE BOX

Pre-labor, or planned/elective (even if spontaneous onset of labor) 1 In labor/intra-partum, or emergency (whether or not in labor) 2

77. Main indication for cesarean section: CHECK ONLY ONE BOX

Dystocia (failure to progress, cephalopelvic disproportion)  01 Fetal distress or abnormal fetal monitoring pattern  02 Placental abruption  03 Placenta previa  04 Breech, unstable lie, transverse lie, or other malpresentation  05 Fetal anomaly (congenital defect or malformation)  06 Maternal hypertension  07 Chorioamnionitis  08 Herpes  09 Cord presentation/prolapse  10 Failed forceps or vacuum  11 Preterm ruptured membranes  12 Intra-uterine growth retardation (IUGR)  13 Macrosomia  14 Patient choice  15 Failed induction  16 Uterine dehiscence/rupture  17 (If “Other”, please specify:______) Other  18

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Induction of Labor

78. Was labor induced? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

79. Main indication for induction: CHECK ONLY ONE BOX

Post dates  01 Hypertensive disorder  02 Renal disease  03 Intra-uterine growth retardation (IUGR)  04 Antepartum hemorrhage  05 Social (elective)  06 Fetal distress  07 Isoimmunization  08 Diabetes  09 Fetal abnormality  10 Fetal death  11 Suspected/proved chorioamnionitis  12 Prolonged rupture of membranes  13 Large for gestational age (LGA) at term  14 Other  15 (If “Other”, please specify: ______)

80. Which of the following was used to induce labor? CHECK “YES” OR “NO” FOR EACH

a. ARM/AROM Yes 1 No 2

b. Mechanical means Yes 1 No 2

c. Prostaglandins Yes 1 No 2

d. Infusion of oxytocic agent Yes 1 No 2 (If “Yes” for infusion of oxytocic agent, SKIP to Question 82)

Augmentation of Labor

81. Was labor augmented by infusion of an oxytocic agent? CHECK ONLY ONE BOX Yes 1 No 2

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Anesthesia/Analgesia

82. Were any of the following agents administered during 1st stage of labor or prior to cesarean section? CHECK “YES” OR “NO” FOR EACH a. Narcotic Yes 1 No 2

b. Nitrous oxide Yes 1 No 2

c. Epidural/caudal Yes 1 No 2

d. Spinal Yes 1 No 2

83. Were any of the following agents administered during 2nd stage of labor (delivery) or in order to perform a cesarean section? CHECK “YES” OR “NO” FOR EACH a. Narcotic Yes 1 No 2

b. Nitrous oxide Yes 1 No 2

c. Vaginal Yes 1 No 2

d. Epidural/caudal Yes 1 No 2

e. Spinal Yes 1 No 2

f. General Yes 1 No 2

Other Medications

84. Were either of the following medications used (orally, subcutaneously, or parenterally) intrapartum after admission for delivery? CHECK “YES” OR “NO” FOR EACH

a. ß-mimetics Yes 1 No 2

b. Corticosteroids Yes 1 No 2

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Meconium Staining

85. Meconium staining of the amniotic fluid/liquor: CHECK ONLY ONE BOX

(SKIP to Question 87) None 1 Thin/light 2 Moderate/thick/heavy/particulate/”pea soup” 3 Not otherwise specified 4 (SKIP to Question 87) Unknown 5

86. When was meconium staining of the amniotic fluid/liquor first noted? CHECK ONLY ONE BOX Prior to rupture of membranes 1 At/after rupture of membranes 2 At delivery 3

87. Was amnioinfusion performed? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

88. Why was amnioinfusion performed? CHECK ONLY ONE BOX

Meconium staining of liquor 1 Variable decelerations on fetal monitoring 2 Unknown 3

Fetal Distress or Non-Reassuring Fetal Monitoring Pattern

89. Was any fetal monitoring used? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 92) No 2

90. Types of fetal monitoring used: CHECK “YES” OR “NO” FOR EACH a. Auscultation Yes 1 No 2 Not specified 3

b. Electronic Yes 1 No 2

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91. Any notation of any of the following abnormal fetal monitoring patterns? CHECK “YES” OR “NO” FOR EACH

a. Non-reassuring fetal monitoring pattern Yes 1 No 2

b. Recurrent severe variable decelerations Yes 1 No 2

c. Loss of beat to beat variability Yes 1 No 2

d. Late deceleration Yes 1 No 2

e. Prolonged deceleration Yes 1 No 2

f. Fetal bradycardia Yes 1 No 2

g. Fetal tachycardia Yes 1 No 2

92. Any notation of fetal distress? CHECK ONLY ONE BOX Yes 1 No 2

93. Are you tired of this form yet? CHECK ONLY ONE BOX Yes 1 No 2

Type and Volume of Fluids Administered during Labor or Delivery

94. Were any IV fluids administered during labor or delivery? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

95. Did any of the IV fluids contain dextrose (glucose)? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

96. On what date was the first IV fluid containing dextrose started? 2 0 0 __ / __ __ / __ __ Year Mo Day

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97. What time was the first IV fluid containing dextrose started? __ __ : __ __

98. What was the total volume infused (or maximum infusion rate if total volume unknown) of all IV fluids containing dextrose? CHECK ONLY ONE BOX AND ENTER THE VALUE Total volume (ml) 1 Rate-ml/hr 2 Rate-ml/min 3

______

Scalp pH/Scalp Lactate Values

99. Was a scalp pH obtained? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 103) No 2

100. Date of scalp pH closest to delivery: 2 0 0 __ / __ __ / __ __ Year Mo Day

101. Time of scalp pH closest to delivery: __ __ : __ __

102. Scalp pH result: __ . ______

103. Was a scalp lactate obtained? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

104. Date of scalp lactate closest to delivery: 2 0 0 __ / __ __ / __ __ Year Mo Day

105. Time of scalp lactate closest to delivery: __ __ : __ __

106. Scalp lactate result: CHECK ONLY ONE BOX AND ENTER THE VALUE mmol/L 1 mg/dL 2

______. __ __

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Duration of Labor

107. Was the delivery a pre-labor or planned/elective cesarean section (even if spontaneous onset of labor)? CHECK ONLY ONE BOX

(SKIP to next section) Yes 1 No 2

108. On what date did stage 1 of labor begin? 2 0 0 __ / __ __ / __ __ Year Mo Day

109. What time did stage 1 of labor begin? __ __ : __ __

110. On what date did stage 2 of labor begin? 2 0 0 __ / __ __ / __ __ Year Mo Day

111. What time did stage 2 of labor begin? __ __ : __ __

Shoulder Dystocia/Birth Injury

112. Any notation of each of the following: CHECK “YES” OR “NO” FOR EACH

a. Shoulder dystocia or shoulder difficulty Yes 1 No 2

b. Use of hip flexion (McRoberts maneuver) Yes 1 No 2

c. Application of supra-pubic pressure Yes 1 No 2

d. Use of internal manipulation (corkscrew or woodscrew maneuver) Yes 1 No 2

e. Application of extra traction to fetal head and shoulders Yes 1 No 2

f. Birth injury or birth trauma Yes 1 No 2 (If “YES” for any of these, refer to the responsible local HAPO investigator for completion of Question 113. Otherwise, SKIP to next section.)

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113. Is shoulder dystocia suspected or present? CHECK ONLY ONE BOX

(Complete an Outcome Review Form – Baby) Yes 1 No 2

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Hospital Discharge – Mother

114. Did the mother have a major postpartum hemorrhage? CHECK ONLY ONE BOX

(Complete an Outcome Review Form – Maternal) Yes 1 No 2

115. Was the mother admitted or transferred to a unit providing intensive care during or following delivery? CHECK ONLY ONE BOX

(Complete an Outcome Review Form – Maternal) Yes 1 No 2

116. Postpartum status of the mother: CHECK ONLY ONE BOX

(SKIP to Question 119) Discharged after delivery 1 (SKIP to next section) Remains in hospital at 4 weeks postpartum 2 Maternal death prior to discharge 3

NOTE-If there was a maternal death, proceed with data abstraction. A Death Form - Maternal and a Study Conclusion Form MUST also be completed.

117. Date of the mother’s death: 2 0 0 __ / __ __ / __ __ Year Mo Day

118. Was an autopsy performed? CHECK ONLY ONE BOX

(SKIP to next section) Yes 1 (SKIP to next section) No 2

119. Date the mother was discharged from the hospital: 2 0 0 __ / __ __ / __ __ Year Mo Day

120. Time the mother was discharged from (or left) the hospital: __ __ : __ __

121. Where was the mother discharged to? CHECK ONLY ONE BOX Home 1 Subacute care facility 2 Acute care facility 3 Not specified 4

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Medical Record Abstraction Form-June-28-00 RecAbstr Page 25 of 35 Affix label here Participant ID

NEONATAL DATA Date and Time of Delivery, Gender

122. Date of delivery: 2 0 0 __ / __ __ / __ __ Year Mo Day

123. Time of delivery: __ __ : __ __

124. Gender: CHECK ONLY ONE BOX Male 1 Female 2 Ambiguous 3

Infant Status

125. Infant status at delivery: CHECK ONLY ONE BOX Live birth 1 (SKIP to Question 128) Antepartum fetal death 2 (SKIP to Question 128) Intrapartum fetal death 3

126. Was there a neonatal death (death within 28 days of livebirth) or infant death (death after 28th day of life)? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

127. Date of neonatal or infant death: 2 0 0 __ / __ __ / __ __ Year Mo Day

128. Was an autopsy performed? CHECK ONLY ONE BOX Yes 1 No 2

Weight/Length/Head Circumference

129. Was birthweight measured in: CHECK ONLY ONE BOX g 1 kg 2 lb/oz 3 (SKIP to Notes following Question 130) Not recorded 4

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Medical Record Abstraction Form-June-28-00 RecAbstr Page 26 of 35 Affix label here Participant ID

130. Birthweight: ENTER THE VALUE ON THE APPROPRIATE LINE

a. ______g

b. __ . ______kg

c. __ __ lb __ __ oz

NOTE-If there was a fetal death, complete a Death Form - Baby and a Study Conclusion Form and skip to Question 195.

NOTE-If there was a neonatal or infant death, proceed with neonatal data abstraction. A Death Form - Baby and a Study Conclusion Form MUST also be completed.

131. Length: CHECK ONLY ONE BOX AND ENTER THE VALUE cm 1 in 2 (SKIP to Question 132) Not recorded 3

__ __ . __

132. Head circumference: CHECK ONLY ONE BOX AND ENTER THE VALUE  cm 1 in 2 (SKIP to next section) Not recorded 3

__ __ . __

Apgar Score

133. Total Apgar score at 1 minute: __ __ ENTER 99 IF NOT RECORDED

134. Total Apgar score at 5 minutes: __ __ ENTER 99 IF NOT RECORDED

(Complete an Outcome Review Form – Baby if 5 minute Apgar < 3)

135. Total Apgar score at 10 minutes: __ __ ENTER 99 IF NOT RECORDED OR NOT PERFORMED

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Cord Blood pH and Base Excess Values

136. Is there a cord blood pH value? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 140) No 2

137. Cord blood pH result: __ . ______

138. Type of blood: CHECK ONLY ONE BOX Arterial 1 Venous 2 Not Specified 3

139. Base excess value: CHECK ONLY ONE BOX AND ENTER THE VALUE Negative 1 Positive 2 (SKIP to Question 140) Not recorded 3

__ __ . __ __

140. Cord blood lactate level: CHECK ONLY ONE BOX AND ENTER THE VALUE mmol/L 1 mg/dL 2 (SKIP to next section) Not recorded 3

__ __ . __ __

141. Type of blood: CHECK ONLY ONE BOX Arterial 1 Venous 2 Not Specified 3

Drug Withdrawal

142. Any notation of diagnosis of drug withdrawal syndrome? CHECK ONLY ONE BOX Yes 1 No 2

143. Is there a positive toxicology report? CHECK ONLY ONE BOX Yes 1 No 2

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Birth Injury

144. Any notation of shoulder dystocia or shoulder difficulty? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 146) No 2

(If “YES”, refer to the responsible local HAPO investigator for completion of Question 145)

145. Is shoulder dystocia suspected or present? CHECK ONLY ONE BOX (Complete an Outcome Review Form – Baby) Yes 1 No 2

146. Any notation of birth injury or birth trauma? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

(If “YES”, refer to the responsible local HAPO investigator for completion of Question 147)

147. Is birth injury suspected or present? CHECK ONLY ONE BOX

(Complete an Outcome Review Form – Baby) Yes 1 No 2

Fetal Malformations

148. Any notation of fetal malformation? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

(If “YES”, refer to the responsible local HAPO investigator for completion of Questions 149-150)

149. Were there any MAJOR fetal malformations (fatal, potentially life threatening, likely to lead to serious handicap, likely to lead to major cosmetic defect, or requires major surgery to repair)? CHECK ONLY ONE BOX Yes 1 (Do NOT answer Question 150) No 2

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150. Which of the following major malformations was present? CHECK “YES” OR “NO” FOR EACH

a. Anencephaly Yes 1 No 2

b. Microcephaly Yes 1 No 2

c. Neural tube defect Yes 1 No 2

d. Transposition of the great arteries (TGA) Yes 1 No 2

e. Ventricular septal defect (VSD) Yes 1 No 2

f. Atrial septal defect (ASD) Yes 1 No 2

g. Single ventricle Yes 1 No 2

h. Coarctation of the aorta (CoA) Yes 1 No 2

i. Situs inversus or dextrocardia Yes 1 No 2

j. Duodenal atresia Yes 1 No 2

k. Anorectal atresia Yes 1 No 2

l. Hydronephrosis Yes 1 No 2

m. Renal agenesis Yes 1 No 2

n. Ureteral duplication Yes 1 No 2

o. Sacral dysgenesis Yes 1 No 2 (GO TO next page-list continues) Continued on next page

Medical Record Abstraction Form-June-28-00 RecAbstr Page 31 of 35 Affix label here Participant ID

 p. Hypoplastic limb (caudal regression syndrome) Yes 1 No 2

q. Holoprosencephaly Yes 1 No 2

r. Ovarian cyst Yes 1 No 2

s. Other Yes 1 No 2 (Complete an Outcome Review Form – Baby for any Major Malformation)

Cardiomegaly

151. Any notation of diagnosis of cardiomegaly or hypertrophic cardiomyopathy? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

(If “YES”, refer to responsible local HAPO investigator for completion of Question 152)

152. Is cardiomegaly or hypertrophic cardiomyopathy confirmed? CHECK ONLY ONE BOX Yes 1 No 2

Small Left Colon Syndrome

153. Any notation of diagnosis of small left colon syndrome? CHECK ONLY ONE BOX

Yes 1 (SKIP to next section) No 2

(If “YES”, refer to responsible local HAPO investigator for completion of Question 154)

154. Is small left colon syndrome confirmed? CHECK ONLY ONE BOX Yes 1 No 2

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Hypoglycemia

155. Any notation of neonatal hypoglycemia? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 159) No 2

156. Were symptoms associated with the neonatal hypoglycemia? CHECK ONLY ONE BOX Yes (symptomatic) 1 (SKIP to Question 158) No (asymptomatic) 2 (SKIP to Question 158) Not reported 3

157. Did the infant have convulsions (seizures) in association with the hypoglycemia? CHECK ONLY ONE BOX

(Complete an Outcome Review Form – Baby) Yes 1 No 2

158. Was the infant given glucose infusion for hypoglycemia? CHECK ONLY ONE BOX Yes 1 No 2

159. Any laboratory reports of blood glucose values? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

160. Lowest blood glucose value (laboratory analysis) at < 6 hours: CHECK ONLY ONE BOX AND ENTER THE VALUE mmol/L 1 mg/dL 2 (SKIP to Question 163) No report 3

______. __ __

161. Date this glucose specimen was drawn: 2 0 0 __ / __ __ / __ __ Year Mo Day

162. Time this glucose specimen was drawn: __ __ : __ __

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163. Lowest blood glucose value (laboratory analysis) at 6-24 hours: CHECK ONLY ONE BOX AND ENTER THE VALUE mmol/L 1 mg/dL 2 (SKIP to Question 166) No report 3

______. __ __

164. Date this glucose specimen was drawn: 2 0 0 __ / __ __ / __ __ Year Mo Day

165. Time this glucose specimen was drawn: __ __ : __ __

166. Lowest blood glucose value (laboratory analysis) at >24 hours: CHECK ONLY ONE BOX AND ENTER THE VALUE mmol/L 1 mg/dL 2 (SKIP to next section) No report 3

______. __ __

167. Date this glucose specimen was drawn: 2 0 0 __ / __ __ / __ __ Year Mo Day

168. Time this glucose specimen was drawn: __ __ : __ __

Respiratory Disorder

169. Any notation of a respiratory disorder? CHECK ONLY ONE BOX Yes 1 (SKIP to next section) No 2

(If “YES”, refer to the responsible local HAPO investigator for completion of Question 170)

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170. Which of the following respiratory disorders were present? CHECK “YES” OR “NO” FOR EACH

a. Apnea Yes 1 No 2

b. Respiratory distress syndrome (RDS, hyaline membrane disease, surfactant deficiency) Yes 1 No 2

c. Meconium aspiration syndrome (MAS) Yes 1 No 2

d. Bacterial pneumonia Yes 1 No 2

e. Transient tachypnea of the newborn (TTN, wet lung) Yes 1 No 2

f. Other Yes 1 No 2 (If “Other”, please specify: ______)

(For RDS-Complete an Outcome Review Form – Baby)

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NICU Admission

171. Any admission to a unit providing higher level care than normal newborn care? CHECK ONLY ONE BOX Yes  1 (SKIP to next section) No  2

a. Date of first admission: 2 0 0 __ / __ __ / __ __ Year Mo Day

b. Time of first admission: __ __ : __ __

c. Level of care: CHECK ONLY ONE BOX NICU/intensive care  1 Intermediate/special care  2

d. Date of discharge: 2 0 0 __ / __ __ / __ __ Year Mo Day

e. Time of discharge: __ __ : __ __

172. Any subsequent admissions to a unit providing higher level care than normal newborn care? CHECK ONLY ONE BOX Yes  1 (SKIP to Question 174) No  2

a. Date of admission: 2 0 0 __ / __ __ / __ __ Year Mo Day

b. Time of admission: __ __ : __ __

c. Level of care: CHECK ONLY ONE BOX NICU/intensive care  1 Intermediate/special care  2

d. Date of discharge: 2 0 0 __ / __ __ / __ __ Year Mo Day

e. Time of discharge: __ __ : __ __

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173. Any further admissions to a unit providing higher level care than normal newborn care? CHECK ONLY ONE BOX Yes  1 (SKIP to Question 174) No  2

a. Date of admission: 2 0 0 __ / __ __ / __ __ Year Mo Day

b. Time of admission: __ __ : __ __

c. Level of care: CHECK ONLY ONE BOX NICU/intensive care  1 Intermediate/special care  2

d. Date of discharge: 2 0 0 __ / __ __ / __ __ Year Mo Day

e. Time of discharge: __ __ : __ __

174. Was there an admission to a unit in a hospital other than the hospital where the delivery occurred? CHECK ONLY ONE BOX Yes 1 (SKIP to Question 176) No 2

175. Were records from that hospital reviewed for abstraction? CHECK ONLY ONE BOX Yes 1 No 2

176. Reason(s) for admission to or care in NICU/special care unit: CHECK “YES” OR “NO” FOR EACH

 a. Respiratory distress syndrome Yes 1 No 2  b. Infection/sepsis Yes 1 No 2  c. Rule out sepsis (and sepsis ruled out) Yes 1 No 2  (GO TO next page-list continues)

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 d. Meconium aspiration Yes 1 No 2  e. Convulsions/seizures Yes 1 No 2  f. Severe hematologic disorder (thrombocytopenia/neutropenia) Yes 1 No 2  g. Hypoglycemia Yes 1 No 2  h. Recurrent apnea Yes 1 No 2  i. Abdominal distension/obstruction Yes 1 No 2  j. Congenital heart disease Yes 1 No 2  k. Anomaly (congenital defect or malformation) Yes 1 No 2  l. Acute renal failure Yes 1 No 2  m. Neonatal abstinence/drug withdrawal Yes 1 No 2  n. Prematurity Yes 1 No 2  o. Low birthweight Yes 1 No 2  p. Observation or investigation Yes 1 No 2  q. Feeding problems Yes 1 No 2

r. Other Yes 1 No 2 (If “Other”, please specify: ______)

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Hyperbilirubinemia/Polycythemia

177. What was the highest bilirubin level reported? CHECK ONLY ONE BOX AND ENTER THE VALUE mg/dL 1 umol/L 2 g/dL or g% 3 g/L 4 (SKIP to Question 179) No report 5

______. ______

178. Date the specimen was drawn: 2 0 0 __ / __ __ / __ __ Year Mo Day

179. Was a diagnosis of hyperbilirubinemia or jaundice recorded? CHECK ONLY ONE BOX Yes 1 No 2

180. Any notation of isoimmunization (ABO or Rh incompatibility) in the infant? CHECK ONLY ONE BOX Yes 1 No 2

181. Any notation of cephalhematoma or extensive ecchymoses? CHECK ONLY ONE BOX Yes 1 No 2

182. Was the infant treated with phototherapy? CHECK ONLY ONE BOX Yes 1 No 2

183. Was the newborn treated with exchange transfusion for jaundice or hyperbilirubinemia? CHECK ONLY ONE BOX

(Complete an Outcome Review Form – Baby) Yes 1 (SKIP to Question 186) No 2

184. Date of first exchange transfusion: 2 0 0 __ / __ __ / __ __ Year Mo Day

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185. Total number of exchange transfusions given: __ __

186. What was the highest hematocrit (Hct or PCV) level reported?: CHECK ONLY ONE BOX AND ENTER THE VALUE % or per 100 1 Proportion of 1.0 2 (SKIP to next section) No report 3

__ __ . ______

187. Was the hematocrit: CHECK ONLY ONE BOX Venous 1 Capillary 2 Not specified 3

188. Date the hematocrit was drawn: 2 0 0 __ / __ __ / __ __ Year Mo Day

189. Time the hematocrit was drawn: __ __ : __ __

190. Was the newborn treated with exchange transfusion for polycythemia (high hematocrit)? CHECK ONLY ONE BOX

(Complete an Outcome Review Form – Baby) Yes 1 No 2

Hospital Discharge – Infant NOTE-If there was a neonatal death or infant death (i.e. “Yes” to Question 126), do NOT complete this section. SKIP to the next section.

191. Was the infant discharged within 4 weeks of delivery? CHECK ONLY ONE BOX Yes 1 (SKIP to the next section) No 2

192. Date the infant was discharged from the hospital: 2 0 0 __ / __ __ / __ __ Year Mo Day

193. Time the infant was discharged from (or left) the hospital: __ __ : __ __

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194. Where was the infant discharged to? CHECK ONLY ONE BOX Home 1 Subacute care facility 2 Acute care facility 3 Not specified 4

Form Completion

195. HAPO staff ID of person who completed this form: ______

196. Was this abstraction done jointly with the PI or his/her designee for the purpose of retraining? CHECK ONLY ONE BOX

Yes 1 (SKIP to Question 198) No 2

197. HAPO staff ID of second abstractor: ______

198. Date medical record abstraction completed: 2 0 0 __ / __ __ / __ __ Year Mo Day

199. HAPO staff ID of person entering data into Data Entry System: ______

Medical Record Abstraction Form-June-28-00