Tieu Joanna, McPhee Andrew J, Crowther Caroline A, Middleton Philippa, Shepherd Emily
ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, 1st floor, Queen Victoria Building, 72 King William Road, Adelaide, South Australia, Australia, 5006.
Cochrane Database Syst Rev. 2017 Aug 3;8(8):CD007222. doi: 10.1002/14651858.CD007222.pub4.
Gestational diabetes mellitus (GDM) is a form of diabetes that occurs in pregnancy. Although GDM usually resolves following birth, it is associated with significant morbidities for mothers and their infants in the short and long term. There is strong evidence to support treatment for GDM. However, there is uncertainty as to whether or not screening all pregnant women for GDM will improve maternal and infant health and if so, the most appropriate setting for screening. This review updates a Cochrane Review, first published in 2010, and subsequently updated in 2014.
To assess the effects of screening for gestational diabetes mellitus based on different risk profiles and settings on maternal and infant outcomes.
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2017), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (14 June 2017), and reference lists of retrieved studies.
We included randomised and quasi-randomised trials evaluating the effects of different protocols, guidelines or programmes for screening for GDM based on different risk profiles and settings, compared with the absence of screening, or compared with other protocols, guidelines or programmes for screening. We planned to include trials published as abstracts only and cluster-randomised trials, but we did not identify any. Cross-over trials are not eligible for inclusion in this review.
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included trials. We resolved disagreements through discussion or through consulting a third reviewer.
We included two trials that randomised 4523 women and their infants. Both trials were conducted in Ireland. One trial (which quasi-randomised 3742 women, and analysed 3152 women) compared universal screening versus risk factor-based screening, and one trial (which randomised 781 women, and analysed 690 women) compared primary care screening versus secondary care screening. We were not able to perform meta-analyses due to the different interventions and comparisons assessed.Overall, there was moderate to high risk of bias due to one trial being quasi-randomised, inadequate blinding, and incomplete outcome data in both trials. We used GRADEpro GDT software to assess the quality of the evidence for selected outcomes for the mother and her child. Evidence was downgraded for study design limitations and imprecision of effect estimates. Universal screening versus risk-factor screening (one trial) MotherMore women were diagnosed with GDM in the universal screening group than in the risk-factor screening group (risk ratio (RR) 1.85, 95% confidence interval (CI) 1.12 to 3.04; participants = 3152; low-quality evidence). There were no data reported under this comparison for other maternal outcomes including hypertensive disorders of pregnancy, caesarean birth, perineal trauma, gestational weight gain, postnatal depression, and type 2 diabetes. ChildNeonatal outcomes: large-for-gestational age, perinatal mortality, mortality or morbidity composite, hypoglycaemia; and childhood/adulthood outcomes: adiposity, type 2 diabetes, and neurosensory disability, were not reported under this comparison. Primary care screening versus secondary care screening (one trial) MotherThere was no clear difference between the primary care and secondary care screening groups for GDM (RR 0.91, 95% CI 0.50 to 1.66; participants = 690; low-quality evidence), hypertension (RR 1.41, 95% CI 0.77 to 2.59; participants = 690; low-quality evidence), pre-eclampsia (RR 0.80, 95% CI 0.36 to 1.78; participants = 690;low-quality evidence), or caesarean section birth (RR 1.00, 95% CI 0.80 to 1.27; participants = 690; low-quality evidence). There were no data reported for perineal trauma, gestational weight gain, postnatal depression, or type 2 diabetes. ChildThere was no clear difference between the primary care and secondary care screening groups for large-for-gestational age (RR 1.37, 95% CI 0.96 to 1.96; participants = 690; low-quality evidence), neonatal complications: composite outcome, including: hypoglycaemia, respiratory distress, need for phototherapy, birth trauma, shoulder dystocia, five minute Apgar less than seven at one or five minutes, prematurity (RR 0.99, 95% CI 0.57 to 1.71; participants = 690; low-quality evidence), or neonatal hypoglycaemia (RR 1.10, 95% CI 0.28 to 4.38; participants = 690; very low-quality evidence). There was one perinatal death in the primary care screening group and two in the secondary care screening group (RR 1.10, 95% CI 0.10 to 12.12; participants = 690; very low-quality evidence). There were no data for neurosensory disability, or childhood/adulthood adiposity or type 2 diabetes.
AUTHORS' CONCLUSIONS: There are insufficient randomised controlled trial data evaluating the effects of screening for GDM based on different risk profiles and settings on maternal and infant outcomes. Low-quality evidence suggests universal screening compared with risk factor-based screening leads to more women being diagnosed with GDM. Low to very low-quality evidence suggests no clear differences between primary care and secondary care screening, for outcomes: GDM, hypertension, pre-eclampsia, caesarean birth, large-for-gestational age, neonatal complications composite, and hypoglycaemia.Further, high-quality randomised controlled trials are needed to assess the value of screening for GDM, which may compare different protocols, guidelines or programmes for screening (based on different risk profiles and settings), with the absence of screening, or with other protocols, guidelines or programmes. There is a need for future trials to be sufficiently powered to detect important differences in short- and long-term maternal and infant outcomes, such as those important outcomes pre-specified in this review. As only a proportion of women will be diagnosed with GDM in these trials, large sample sizes may be required.
妊娠期糖尿病(GDM)是一种在孕期发生的糖尿病形式。尽管GDM通常在产后缓解,但它在短期和长期内都与母亲及其婴儿的重大发病风险相关。有强有力的证据支持对GDM进行治疗。然而,对于是否对所有孕妇进行GDM筛查会改善母婴健康,以及如果是这样,最合适的筛查环境尚不确定。本综述更新了一篇Cochrane综述,该综述于2010年首次发表,随后在2014年进行了更新。
评估基于不同风险特征和筛查环境进行妊娠期糖尿病筛查对母婴结局的影响。
我们检索了Cochrane妊娠与分娩试验注册库(2017年1月31日)、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台(ICTRP)(2017年6月14日)以及检索到的研究的参考文献列表。
我们纳入了随机和半随机试验,这些试验评估了基于不同风险特征和筛查环境的不同方案、指南或项目对GDM筛查的效果,并与未进行筛查或与其他筛查方案、指南或项目进行比较。我们计划纳入仅以摘要形式发表的试验和整群随机试验,但未识别到任何此类试验。交叉试验不符合纳入本综述的条件。
两位综述作者独立评估研究的合格性、提取数据并评估纳入试验的偏倚风险。我们通过讨论或咨询第三位审阅者解决分歧。
我们纳入了两项试验,共随机分配了4523名妇女及其婴儿。两项试验均在爱尔兰进行。一项试验(对3742名妇女进行半随机分组,并分析了3152名妇女)比较了普遍筛查与基于风险因素的筛查,另一项试验(对781名妇女进行随机分组,并分析了690名妇女)比较了初级保健筛查与二级保健筛查。由于评估的干预措施和比较不同,我们无法进行荟萃分析。总体而言,由于一项试验为半随机试验、盲法不足以及两项试验中结局数据不完整,存在中度至高度偏倚风险。我们使用GRADEpro GDT软件评估母亲及其孩子选定结局的证据质量。由于研究设计局限性和效应估计的不精确性,证据被降级。普遍筛查与基于风险因素的筛查(一项试验)母亲在普遍筛查组中被诊断为GDM的女性多于基于风险因素筛查组(风险比(RR)1.85,95%置信区间(CI)为1.12至3.04;参与者 = 3152;低质量证据)。在此比较下,未报告其他孕产妇结局的数据,包括妊娠高血压疾病、剖宫产、会阴创伤、孕期体重增加、产后抑郁和2型糖尿病。儿童新生儿结局:大于胎龄儿、围产期死亡率、死亡率或发病率综合指标、低血糖;以及儿童期/成年期结局:肥胖、2型糖尿病和神经感觉障碍,在此比较下均未报告。初级保健筛查与二级保健筛查(一项试验)母亲在初级保健筛查组和二级保健筛查组之间,GDM(RR 0.91,95% CI 0.50至1.66;参与者 = 690;低质量证据)、高血压(RR 1.41,95% CI 0.77至2.59;参与者 = 690;低质量证据)、先兆子痫(RR 0.80,95% CI 0.36至1.78;参与者 = 690;低质量证据)或剖宫产出生(RR 1.00,95% CI 0.80至1.27;参与者 = 690;低质量证据)方面没有明显差异。未报告会阴创伤、孕期体重增加、产后抑郁或2型糖尿病的数据。儿童在初级保健筛查组和二级保健筛查组之间,大于胎龄儿(RR 1.37,95% CI 0.96至1.96;参与者 = 690;低质量证据)、新生儿并发症综合指标(包括低血糖、呼吸窘迫、光疗需求、出生创伤、肩难产、1分钟或5分钟时5分钟Apgar评分低于7分、早产)(RR 0.99,95% CI 0.57至1.71;参与者 = 690;低质量证据)或新生儿低血糖(RR 1.10,95% CI 0.28至4.38;参与者 = 690;极低质量证据)方面没有明显差异。初级保健筛查组有1例围产期死亡,二级保健筛查组有2例(RR 1.10,95% CI 0.10至12.12;参与者 = 690;极低质量证据)。未报告神经感觉障碍、儿童期/成年期肥胖或2型糖尿病的数据。
评估基于不同风险特征和筛查环境进行GDM筛查对母婴结局影响的随机对照试验数据不足。低质量证据表明,与基于风险因素的筛查相比,普遍筛查会导致更多女性被诊断为GDM。低至极低质量证据表明,在GDM、高血压、先兆子痫、剖宫产、大于胎龄儿、新生儿并发症综合指标和低血糖等结局方面,初级保健筛查和二级保健筛查之间没有明显差异。此外,需要高质量的随机对照试验来评估GDM筛查的价值,这些试验可以比较不同的筛查方案、指南或项目(基于不同的风险特征和筛查环境)与不进行筛查或与其他方案、指南或项目。未来的试验需要有足够的样本量来检测母婴短期和长期结局的重要差异,例如本综述预先指定的那些重要结局。由于在这些试验中只有一部分女性会被诊断为GDM,可能需要大样本量。