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| 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 |
| Yang X, Tian H, Zhang F, Zhang C, Li Y, Leng J, Wang L, Liu G, Dong L, Yu Z, Hu G, Chan JCN |
| Journal of Translational Medicine 2014 Oct 28;12(290):Epub |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: 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. We tested the effectiveness of lifestyle modifications implemented in a 3-tier's shared care (SC) on pregnancy outcomes of GDM. METHODS: Between December 2010 and October 2012, we randomly assigned 700 women with IADPSG-defined GDM but without diabetes at 26.3 (interquartile range 25.4 to 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). RESULTS: Women 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 (3,469 versus 3,371 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 to 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 to 3.28). Apgar score at 1 min < 7 was lower but preeclampsia was higher in the SC than in the UC. CONCLUSIONS: Lifestyle modifications using a SC system improved pregnancy outcomes in Chinese women with GDM. TRIAL REGISTRATION: ClinicalTrials.gov; NCT01565564.
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