Cost effectiveness of different screening strategies for gestational diabetes mellitus screening: study protocol of a randomized community non-inferiority trial
Authors: Ramezani Tehrani Fahimeh ,   Gulf Study Cooperative Research Group, Behboudi-Gandevani Samira , Abedini Mehrandokht , Soleymani-Dodaran Masoud , Khalili Davood , Farzadfar Farshad , Hoseinpanah Farhad , Hadaegh Farzad , Valizadeh Majid , Torkestani Farahnaz , Abdollahi Zahra , Bakhshandeh Marzieh , Bidhendi Yarandi Razieh , Zokaee Mehdi , Bidarpour Farzam , Javanbakht Mehdi , Nabipour Iraj , Mansournia Mohammad Ali , Nasli Esfahani Ensieh , Ostovar Afshin , Azizi Fereidoun , Najari Abbas , Khajeian Abdolmohhamad , Anaraki Azita , Ghazaghi Fariba , Lahouni Forouzan , Kalantari Forouzandeh , Fallah Hossein , Kordi Khadije , Saed Lotfollah , Norooozzadeh Mahsa , Farahmand Maryam , Rostami Dovom Marzieh , Hedayati Mehdi , Mehdizade Mehdi , Amiri Mina , Lotfi Mohammad Hassan , Motlagh Mohammad-Esmaeil , Bashghareh Mozhgan , Zamanipour Nosrat , Mirmiran Parvin , Sadeghian Sharif Saeid , Shahraz Saeid , Khari Samareh , Alishahi Sedigheh , Shahgheibi Shole , Nazarpour Sima , Mehrabi Yadollah , Ghaedmohammadi Zahra 
Published: December 2019

Background

There 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).

Methods

This 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.

Results

This study will enable us to compare the cost effectiveness of different GDM screening protocols and intervention intensity (low versus high).

Conclusion

Results which if needed, will also enable policy makers to optimize the national GMD strategy as a resource for enhancing GDM guidelines.

Trial registrationName 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