Cost effectiveness of different screening strategies for gestational diabetes mellitus screening: study protocol of a randomized community non-inferiority trial

Fahimeh Ramezani Tehrani

doi:10.1186/s13098-019-0493-z

Abstract

BackgroundThere is lack of ideal and comprehensive economic evaluations of various GDM strategies. The aim of this study is to the compare efficacy and cost-effectiveness of five different methods of screening for gestational diabetes mellitus (GDM).MethodsThis study is a randomized community non-inferiority trial among 30,000 pregnant women in five different geographic regions of Iran, who were randomly assigned to one of the five GDM screening methods. All first trimester pregnant women, seeking prenatal care in governmental health care systems, who met our eligibility criteria were enrolled. The criteria suggested by the International-Association-of-Diabetes-in-Pregnancy-Study-Group, the most intensive approach, were used as reference. We used the non-inferiority approach to compare less intensive strategies to the reference one. Along with routine prenatal standard care, all participants were scheduled to have two phases of GDM screening in first and second-trimester of pregnancy, based on five different pre-specified protocols. The screening protocol included fasting plasma glucose in the first trimester and either a one step or a two-step screening method in the second trimester of pregnancy. Pregnant women were classified in three groups based on the results: diagnosed with preexisting pre-gestational overt diabetes; gestational diabetes and non-GDM women. Each group received packages for standard-care and all participants were followed till delivery; pregnancy outcomes, quality of life and cost of health care were recorded in detail using specific standardized questionnaires. Primary outcomes were defined as % birth-weight > 90th percentile and primary cesarean section. In addition, we assessed the direct health care direct and indirect costs.ResultsThis study will enable us to compare the cost effectiveness of different GDM screening protocols and intervention intensity (low versus high).ConclusionResults which if needed, will also enable policy makers to optimize the national GMD strategy as a resource for enhancing GDM guidelines.Trial registration Name of the registry: Iranian Registry of Clinical Trials. Trial registration number: IRCT138707081281N1. Date of registration: 2017-02-15. URL of trial registry record: https://www.irct.ir/trial/518

Highlights

There is lack of ideal and comprehensive economic evaluations of various gestational diabetes mellitus (GDM) strategies
Gestational diabetes (GDM) defined as hyperglycaemia at any time during pregnancy at levels below those that occurring in overt diabetes [1]
Evidence shows that treatment of GDM is effective in reducing the risk of many of the important adverse pregnancy outcomes [12,13,14]

Summary

Introduction

There is lack of ideal and comprehensive economic evaluations of various GDM strategies. Despite the globally accepted importance of screening for and treating GDM [13], screening strategies, testing methods and even diagnostic optimum glycemic thresholds for GDM remained much controversy for decades and no international consensus has been yet established [15]. The former screenings were mainly performed to prevent adverse maternal outcomes compared to neonatal complications. The associations of mild GDM with adverse pregnancy outcomes are not completely understood; there is ongoing debate about the benefits of treating mild GDM and the impact on health care costs [18,19,20,21]

Objectives

Methods

Conclusion