The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study

Abstract

HAPO is a 5-year investigator-initiated prospective observational study that will recruit approximately 25000 pregnant women in 10 countries. HAPO utilizes a Central Laboratory for measurement of key metabolic variables, a Clinical Coordinating Center, a Data Coordinating Center, and an independent Data Monitoring Committee. Glucose tolerance is assessed by a 75 g 2-h OGTT at 24-32 weeks' gestation. Results are unblinded to the woman and her caregivers if: fasting plasma glucose >5.8 mmol/l, 2-h plasma glucose >11.1 mmol/l or any plasma glucose <2.5 mmol/l. Random plasma glucose measurement is performed at 34-37 weeks or if symptoms suggest hyperglycemia; results are unblinded for values > or = 8.9 mmol/l. Sociodemographic and health history data are collected via questionnaire and medical record abstraction. Maternal blood is obtained for measurement of serum C-peptide and hemoglobin A1c (HbA(1C)), cord blood for serum C-peptide and plasma glucose, and a capillary specimen is taken between 1 and 2 h following delivery for neonatal plasma glucose. Neonatal anthropometrics are obtained, and follow-up data are collected at 4-6 weeks post-delivery. The primary outcomes to be assessed in relation to maternal glycemia are cesarean delivery, increased fetal size (macrosomia/LGA/obesity), neonatal morbidity (hypoglycemia), and fetal hyperinsulinism.