The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study: paving the way for new diagnostic criteria for gestational diabetes mellitus

Abstract

The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study was performed in response to the need for internationally agreed upon diagnostic criteria for gestational diabetes, based upon their predictive value for adverse pregnancy outcome. Increases in each of the three values on the 75 gram, 2-hour oral glucose tolerance test are associated with graded increases in the likelihood of pregnancy outcomes such as large for gestational age, cesarean section, fetal insulin levels and neonatal fat content. Based upon an iterative process of decision making, a task force of the International Association of Diabetes in Pregnancy Study Groups (IADPSG) recommends that the diagnosis of gestational diabetes be made when any of the following three 75 gram 2-hour OGTT thresholds are met or exceeded: Fasting 92 mg/dL, one hour 180 mg/dL, two hours 153 mg/dL. Various authoritative bodies around the world are expected to deliberate the adoption of these criteria. KeywordsDiagnostic OGTT criteria; Gestational diabetes; HAPO study At present there is a lack of international consistency with regard to the diagnosis of gestational diabetes. While a glucose tolerance test is commonly employed, glucose challenge dosages vary and diagnostic thre challenge is widely used throughout the sholds are myriad. The 75 gram glucose roughout the world for diagnostic testing in the nonpregnant state. At the Third International Workshop-Conference on Gestational Diabetes in 1990 1 a series of recommendations were made which included universal employment of the 75 gram glucose challenge during pregnancy. Some sets of diagnostic criteria, such as those proposed by the World Health Organization, were simply based on criteria used in nonpregnant individuals, and did not take into account changes in carbohydrate metabolism brought about by the pregnant state. Others, such as the "O'Sullivan criteria" 2 in use in North America, were based on data from pregnant women, but were derived mathematically as being two standard Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript deviations above the mean, and were validated for their predictive value for future diabetes in the mother, rather than on pregnancy outcomes. The organizers advocated for international agreement on all aspects of diagnostic testing, and for the development of criteria based on pregnancy outcomes.Subsequently a group of investigators from the disciplines of obstetrics and gynecology, diabetology and neonatology, based in North America, Europe, Asia and the Middle Eas...

A two-step screening algorithm including fasting plasma glucose measurement and a risk estimation model is an accurate strategy for detecting gestational diabetes mellitus

“…While most of these studies were technically well performed, they reflect the inconsistency of strategies and thresholds for diagnosing GDM [11]. The IADPSG Consensus Panel recently revised its recommendations for the diagnosis of GDM, particularly based on the results of the HAPO (Hyperglycemia and Adverse Pregnancy Outcome) study, aiming to close the 'lack of international uniformity in the approach to ascertainment and diagnosis of GDM' [20,25]. Although OGTT screening is recommended for all pregnant women, the Consensus Panel stated that more cost-effective strategies that do not require an OGTT should be developed.…”

“…The requirement for an overnight fast might be a limitation; however, FPG measurement has been suggested to have a better test accuracy as a random plasma glucose test with reproducible values throughout the entire pregnancy [11,27]. The HAPO study further estimated that FPG measurement identifies about 50% of all affected women without additional 1 and 2 h OGTT values [25]. This is comparable to our findings, where 40-65% of women with GDM were diagnosed by an FPG level of 5.1 mmol/l or above in both the validation and evaluation cohorts.…”

Compliance with National Institute of Health and Care Excellence risk-based screening for Gestational Diabetes Mellitus in nulliparous women

“…(10,11) The Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) Study demonstrated that the degree of maternal glucose abnormality correlated with the severity of adverse pregnancy outcomes. (12) Women with GDM are also at significantly higher risk (up to 40%) of developing type 2 diabetes later in life. (13)(14)(15) GDM can be detected in pregnancy using a blood test to screen for elevated blood glucose concentrations during the antenatal period.…”

Towards biomarker-based tests that can facilitate decisions about prevention and management of preeclampsia in low-resource settings

“…Given the physiological complexity of PE/E, a large, collaborative multisite study along the lines of the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study [68] would be ideally suited to answer this question. Such a study would ultimately result in consensus regarding a screening and diagnostic algorithm.…”