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Hyperglycemia and Adverse Pregnancy Outcome
(HAPO)
There is a consensus that overt diabetes mellitus (DM), whether or not accompanied
by symptoms or signs of metabolic decompensation, is associated with a significant
risk of adverse pregnancy outcome. On
the other hand, the risk of adverse outcome associated with degrees of glucose
intolerance less severe than overt DM is controversial. The Hyperglycemia and
Adverse Pregnancy Outcome (HAPO) Study is a basic
epidemiologic investigation aiming to clarify unanswered questions on the association
of various levels of glucose intolerance during the third trimester of pregnancy
and risk of adverse outcomes. Its General Aim -- by means of an international
cooperative study involving 16 centers and approximately 25,000 pregnant women
-- is to achieve a major advance in knowledge on levels of glucose during pregnancy
that place the mother, fetus, and neonate at increased risk. The primary hypothesis
is that hyperglycemia during pregnancy, less severe than overt DM, is associated
with increased risk of adverse maternal, fetal, and neonatal outcome that is
independently related to the degree of metabolic disturbance. Specific Aims
of HAPO are: 1. to examine glucose tolerance in a large, heterogeneous, multinational,
multicultural, ethnically diverse cohort of women in the third trimester of
gestation with medical caregivers "blinded" to status of glucose
tolerance (except in those instances where fasting and/or two hour OGTT plasma
glucose concentration exceeds a predefined cutoff value); and 2. to derive
internationally acceptable criteria for the diagnosis and classification of
gestational diabetes mellitus (GDM) based on the specific relationships between
maternal glycemia and the risk of specific adverse outcomes that are established
through this study. The study is being accomplished with high quality standardized
data collection on the women during the third trimester of gestation (including
the OGTT) and at time of delivery for assessment of adverse outcomes, including
operative delivery (caesarean section), increased fetal size (macrosomia/obesity),
neonatal morbidity (hypoglycemia), and fetal hyperinsulinism. HAPO includes
a Clinical Coordinating Center and Data Coordinating Center, both located at
the Northwestern University Medical School in Chicago, as well as a Central
Laboratory located in Belfast, United Kingdom.
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