A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes.

Xilin Yang,Fuxia Zhang,Cuiping Zhang,Junhong Leng,Gang Hu,Leishen Wang,Zhijie Yu,Ling Dong,Yi Li,Huiguang Tian,Gongsu Liu,Juliana Cn Chan

doi:10.1186/s12967-014-0290-2

Abstract

BackgroundThere are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group’s (IADPSG) criteria. We tested the effectiveness of lifestyle modifications implemented in a 3-tier’s shared care (SC) on pregnancy outcomes of GDM.MethodsBetween December 2010 and October 2012, we randomly assigned 700 women with IADPSG-defined GDM but without diabetes at 26.3 (interquartile range: 25.4-27.3) gestational weeks in Tianjin, China, to receive SC or usual care (UC). The SC group received individual consultations and group sessions and performed regular self-monitoring of blood glucose compared to one hospital-based education session in the UC group. The outcomes were macrosomia defined as birth weight ≥ 4.0 kg and the pregnancy-induced hypertension (PIH).ResultsWomen in the SC (n = 339) and UC (n = 361) groups delivered their infants at similar gestational weeks. Birth weight of infants in the SC group was lower than that in the UC group (3469 vs. 3371 grams, P = 0.021). The rate of macrosomia was 11.2% (38/339) in the SC group compared to 17.5% (63/361) in the UC group with relative risk (RR) of 0.64 (95% CI: 0.44-0.93). The rate of PIH was 8.0% (27/339) in the SC compared to 4.4% (16/361) in the UC with RR of 1.80 (0.99-3.28). Apgar score at 1 min < 7 was lower but preeclampsia was higher in the SC than in the UC.ConclusionsLifestyle modifications using a SC system improved pregnancy outcomes in Chinese women with GDM.Trial registrationClinicaltrials.gov; NCT01565564.Electronic supplementary materialThe online version of this article (doi:10.1186/s12967-014-0290-2) contains supplementary material, which is available to authorized users.

Highlights

There are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group’s (IADPSG) criteria
The rates of macrosomia and preeclampsia were significantly reduced [10]. Another multicenter randomised trial from the US [9] reported that intensive intervention in women with GDM defined by a 100-gram 3-hour (OGTT) and the Fourth International Workshop-Conference on GDM’s criteria [12] did not reduce the predefined composite endpoint of neonatal morbidity and its components but significantly reduced the rates of macrosomia, shoulder dystocia and pregnancy-induced hypertension (PIH) [9]
The women assigned to the shared care (SC) group had a marginally shorter body height and had a marginally higher fasting Plasma glucose (PG) at the oral glucose tolerance test (OGTT) than the usual care (UC) group (Table 1)

Summary

Introduction

There are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group’s (IADPSG) criteria. The rates of macrosomia and preeclampsia were significantly reduced [10] Another multicenter randomised trial from the US [9] reported that intensive intervention in women with GDM defined by a 100-gram 3-hour (OGTT) and the Fourth International Workshop-Conference on GDM’s criteria [12] did not reduce the predefined composite endpoint of neonatal morbidity and its components (stillbirth or neonatal death, hypoglycemia, etc.) but significantly reduced the rates of macrosomia, shoulder dystocia and pregnancy-induced hypertension (PIH) [9]. There is no randomised trials to demonstrate that intensive intervention is able to achieve similar effects on pregnancy outcomes as among GDM diagnosed by either the WHO’s criteria [11] or the Fourth International Workshop-Conference on GDM’s criteria [12]

Methods

Results

Conclusion