Brown Julie, Alwan Nisreen A, West Jane, Brown Stephen, McKinlay Christopher Jd, Farrar Diane, Crowther Caroline A
Liggins Institute, The University of Auckland, Park Rd, Grafton, Auckland, New Zealand, 1142.
Academic Unit of Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, Hampshire, UK, SO16 6YD.
Cochrane Database Syst Rev. 2017 May 4;5(5):CD011970. doi: 10.1002/14651858.CD011970.pub2.
Gestational diabetes (GDM) is glucose intolerance, first recognised in pregnancy and usually resolving after birth. GDM is associated with both short- and long-term adverse effects for the mother and her infant. Lifestyle interventions are the primary therapeutic strategy for many women with GDM.
To evaluate the effects of combined lifestyle interventions with or without pharmacotherapy in treating women with gestational diabetes.
We searched the Pregnancy and Childbirth Group's Trials Register (14 May 2016), ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) (14th May 2016) and reference lists of retrieved studies.
We included only randomised controlled trials comparing a lifestyle intervention with usual care or another intervention for the treatment of pregnant women with GDM. Quasi-randomised trials were excluded. Cross-over trials were not eligible for inclusion. Women with pre-existing type 1 or type 2 diabetes were excluded.
We used standard methodological procedures expected by the Cochrane Collaboration. All selection of studies, data extraction was conducted independently by two review authors.
Fifteen trials (in 45 reports) are included in this review (4501 women, 3768 infants). None of the trials were funded by a conditional grant from a pharmaceutical company. The lifestyle interventions included a wide variety of components such as education, diet, exercise and self-monitoring of blood glucose. The control group included usual antenatal care or diet alone. Using GRADE methodology, the quality of the evidence ranged from high to very low quality. The main reasons for downgrading evidence were inconsistency and risk of bias. We summarised the following data from the important outcomes of this review. Lifestyle intervention versus control groupFor the mother:There was no clear evidence of a difference between lifestyle intervention and control groups for the risk of hypertensive disorders of pregnancy (pre-eclampsia) (average risk ratio (RR) 0.70; 95% confidence interval (CI) 0.40 to 1.22; four trials, 2796 women; I = 79%, Tau = 0.23; low-quality evidence); caesarean section (average RR 0.90; 95% CI 0.78 to 1.05; 10 trials, 3545 women; I = 48%, Tau = 0.02; low-quality evidence); development of type 2 diabetes (up to a maximum of 10 years follow-up) (RR 0.98, 95% CI 0.54 to 1.76; two trials, 486 women; I = 16%; low-quality evidence); perineal trauma/tearing (RR 1.04, 95% CI 0.93 to 1.18; one trial, n = 1000 women; moderate-quality evidence) or induction of labour (average RR 1.20, 95% CI 0.99 to 1.46; four trials, n = 2699 women; I = 37%; high-quality evidence).More women in the lifestyle intervention group had met postpartum weight goals one year after birth than in the control group (RR 1.75, 95% CI 1.05 to 2.90; 156 women; one trial, low-quality evidence). Lifestyle interventions were associated with a decrease in the risk of postnatal depression compared with the control group (RR 0.49, 95% CI 0.31 to 0.78; one trial, n = 573 women; low-quality evidence).For the infant/child/adult:Lifestyle interventions were associated with a reduction in the risk of being born large-for-gestational age (LGA) (RR 0.60, 95% CI 0.50 to 0.71; six trials, 2994 infants; I = 4%; moderate-quality evidence). Birthweight and the incidence of macrosomia were lower in the lifestyle intervention group.Exposure to the lifestyle intervention was associated with decreased neonatal fat mass compared with the control group (mean difference (MD) -37.30 g, 95% CI -63.97 to -10.63; one trial, 958 infants; low-quality evidence). In childhood, there was no clear evidence of a difference between groups for body mass index (BMI) ≥ 85th percentile (RR 0.91, 95% CI 0.75 to 1.11; three trials, 767 children; I = 4%; moderate-quality evidence).There was no clear evidence of a difference between lifestyle intervention and control groups for the risk of perinatal death (RR 0.09, 95% CI 0.01 to 1.70; two trials, 1988 infants; low-quality evidence). Of 1988 infants, only five events were reported in total in the control group and there were no events in the lifestyle group. There was no clear evidence of a difference between lifestyle intervention and control groups for a composite of serious infant outcome/s (average RR 0.57, 95% CI 0.21 to 1.55; two trials, 1930 infants; I = 82%, Tau = 0.44; very low-quality evidence) or neonatal hypoglycaemia (average RR 0.99, 95% CI 0.65 to 1.52; six trials, 3000 infants; I = 48%, Tau = 0.12; moderate-quality evidence). Diabetes and adiposity in adulthood and neurosensory disability in later childhoodwere not prespecified or reported as outcomes for any of the trials included in this review.
AUTHORS' CONCLUSIONS: Lifestyle interventions are the primary therapeutic strategy for women with GDM. Women receiving lifestyle interventions were less likely to have postnatal depression and were more likely to achieve postpartum weight goals. Exposure to lifestyle interventions was associated with a decreased risk of the baby being born LGA and decreased neonatal adiposity. Long-term maternal and childhood/adulthood outcomes were poorly reported.The value of lifestyle interventions in low-and middle-income countries or for different ethnicities remains unclear. The longer-term benefits or harms of lifestyle interventions remains unclear due to limited reporting.The contribution of individual components of lifestyle interventions could not be assessed. Ten per cent of participants also received some form of pharmacological therapy. Lifestyle interventions are useful as the primary therapeutic strategy and most commonly include healthy eating, physical activity and self-monitoring of blood glucose concentrations.Future research could focus on which specific interventions are most useful (as the sole intervention without pharmacological treatment), which health professionals should give them and the optimal format for providing the information. Evaluation of long-term outcomes for the mother and her child should be a priority when planning future trials. There has been no in-depth exploration of the costs 'saved' from reduction in risk of LGA/macrosomia and potential longer-term risks for the infants.
妊娠期糖尿病（GDM）是指在孕期首次被识别出的葡萄糖不耐受情况，通常在产后缓解。GDM对母亲及其婴儿均有短期和长期的不良影响。生活方式干预是许多GDM女性的主要治疗策略。
评估联合生活方式干预（无论是否联合药物治疗）对妊娠期糖尿病女性的治疗效果。
我们检索了妊娠与分娩组试验注册库（2016年5月14日）、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台（ICTRP）（2016年5月14日）以及检索到研究的参考文献列表。
我们仅纳入了比较生活方式干预与常规护理或其他干预措施治疗GDM孕妇的随机对照试验。排除了半随机试验。交叉试验不符合纳入标准。已患1型或2型糖尿病的女性被排除。
我们采用了Cochrane协作网期望的标准方法程序。所有研究的选择、数据提取均由两位综述作者独立进行。
本综述纳入了15项试验（45篇报告）（4501名女性，3768名婴儿）。没有一项试验由制药公司的有条件资助。生活方式干预包括多种组成部分，如教育、饮食、运动和血糖自我监测。对照组包括常规产前护理或仅饮食干预。采用GRADE方法，证据质量从高到非常低。证据降级的主要原因是不一致性和偏倚风险。我们总结了本综述重要结局的以下数据。生活方式干预组与对照组相比：
生活方式干预组与对照组在妊娠高血压疾病（先兆子痫）风险方面没有明显差异（平均风险比（RR）0.70；95%置信区间（CI）0.40至1.22；4项试验，2796名女性；I² = 79%，Tau² = 0.23；低质量证据）；剖宫产（平均RR 0.90；95% CI 0.78至1.05；10项试验，3545名女性；I² = 48%，Tau² = 0.02；低质量证据）；2型糖尿病的发生（最长随访10年）（RR 0.98，95% CI 0.54至1.76；2项试验，486名女性；I² = 16%；低质量证据）；会阴创伤/撕裂（RR 1.04，95% CI 0.93至1.18；1项试验，n = 1000名女性；中等质量证据）或引产（平均RR 1.20，95% CI 0.99至1.46；4项试验，n = 2699名女性；I² = 37%；高质量证据）。
生活方式干预组中产后一年达到产后体重目标的女性比对照组更多（RR 1.75，95% CI 1.05至2.90；156名女性；1项试验，低质量证据）。与对照组相比，生活方式干预与产后抑郁症风险降低相关（RR 0.49，95% CI 0.31至0.78；1项试验，n = 573名女性；低质量证据）。
对于婴儿/儿童/成人：
生活方式干预与大于胎龄儿（LGA）出生风险降低相关（RR 0.60，95% CI 0.50至0.71；6项试验，2994名婴儿；I² = 4%；中等质量证据）。生活方式干预组的出生体重和巨大儿发生率较低。
与对照组相比，接受生活方式干预与新生儿脂肪量减少相关（平均差（MD）-37.30 g，95% CI -63.97至-10.63；1项试验，958名婴儿；低质量证据）。在儿童期，两组在体重指数（BMI）≥第85百分位数方面没有明显差异（RR 0.91，95% CI 0.75至1.11；3项试验，767名儿童；I² = 4%；中等质量证据）。
生活方式干预组与对照组在围产期死亡风险方面没有明显差异（RR 0.09，95% CI 0.01至1.70；2项试验，1988名婴儿；低质量证据）。在1988名婴儿中，对照组总共仅报告了5例事件，生活方式干预组没有事件发生。生活方式干预组与对照组在严重婴儿结局综合指标方面没有明显差异（平均RR 0.57，95% CI 0.21至1.55；2项试验，1930名婴儿；I² = 82%，Tau² = 0.44；极低质量证据）或新生儿低血糖（平均RR 0.99，95% CI 0.65至1.52；6项试验，3000名婴儿；I² = 48%，Tau² = 0.12；中等质量证据）。成年期糖尿病和肥胖以及儿童后期神经感觉障碍在本综述纳入的任何试验中均未预先设定或报告为结局。
生活方式干预是GDM女性的主要治疗策略。接受生活方式干预的女性产后患抑郁症的可能性较小，更有可能实现产后体重目标。接受生活方式干预与婴儿出生为LGA的风险降低以及新生儿肥胖减少相关。长期的母亲和儿童/成人结局报告不佳。生活方式干预在低收入和中等收入国家或不同种族中的价值仍不清楚。由于报告有限，生活方式干预的长期益处或危害仍不清楚。无法评估生活方式干预各个组成部分的贡献。10%的参与者还接受了某种形式的药物治疗。生活方式干预作为主要治疗策略是有用的，最常见的包括健康饮食、体育活动和血糖浓度自我监测。未来的研究可以集中在哪些具体干预措施最有用（作为无药物治疗的唯一干预措施）、应由哪些卫生专业人员提供这些措施以及提供信息的最佳形式。在规划未来试验时应优先评估母亲及其孩子的长期结局。尚未深入探讨因LGA/巨大儿风险降低而“节省”的成本以及婴儿潜在的长期风险。
