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

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.

Effect of a new self‐care guide package on maternal and neonatal outcomes in gestational diabetes: A randomized control trial

“…In the present study, there was no differences between the two groups in terms of delivery type. For other interventions, no differences were found in maternal and obstetric outcomes such as maternal hospitalization days, type of delivery, postpartum complications, and rates of cesarean delivery . The high prevalence of previous cesarean delivery in the present study may explain why there was no significant difference in delivery type between the two groups.…”

“…In the present study, a number of important neonatal outcomes, such as Apgar scores in the 1st and 5th min after birth and hospitalization of newborns, were significantly better in the intervention group. Numerous studies have reported that self‐care educational interventions have a significant effect on neonatal outcomes, such as infant hospitalization, Apgar score < 7, preterm delivery, and birth weight . However, other studies indicate that there is no difference in neonatal hospitalization days, birth weight, admission to the neonatal intensive care unit neonatal complications and death, and preterm labor after self‐care educational intervention.…”

“…Numerous studies have reported that self‐care educational interventions have a significant effect on neonatal outcomes, such as infant hospitalization, Apgar score < 7, preterm delivery, and birth weight . However, other studies indicate that there is no difference in neonatal hospitalization days, birth weight, admission to the neonatal intensive care unit neonatal complications and death, and preterm labor after self‐care educational intervention. Most studies that found no benefit of the intervention provided interventions with only one educational session or interventions in only one self‐care setting .…”

Maternal and fetal outcome of comparative study between old & adopted new value of screening of Gestational Diabetes Mellitus in tertiary centre in Saudi Arabia

“…Our indings agree with those of [14] which showed that lifestyle modi ication improved pregnancy outcome in Chinese women with GDM. An important fact that needs to be noted is the high incidence of admission of the babies with hyperbillirubenimea to NICU in comparison to previously studied years in our hospital & other institutes.…”

Pregnancy outcomes of Chinese women with gestational diabetes mellitus defined by the IADPSG's but not by the 1999 WHO's criteria

“…Among 1378 women with GDM diagnosed by IADPSG's criteria, 853 women ( N = 427 in the assigned shared care (SC, i.e. intensive lifestyle intervention) group and N = 426 in the assigned UC group) participated in a randomized controlled translational trial . However, due to logistic reasons, 108 women in the assigned UC group during Nov 2010 to July 2011 might have received unintentional intervention, subject to potential contamination.…”