Tieu Joanna, Middleton Philippa, Crowther Caroline A, 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 11;8(8):CD007776. doi: 10.1002/14651858.CD007776.pub3.
Infants born to mothers with pre-existing type 1 or type 2 diabetes mellitus are at greater risk of congenital anomalies, perinatal mortality and significant morbidity in the short and long term. Pregnant women with pre-existing diabetes are at greater risk of perinatal morbidity and diabetic complications. The relationship between glycaemic control and health outcomes for both mothers and infants indicates the potential for preconception care for these women to be of benefit. This is an update of the original review, which was first published in 2010.
To assess the effects of preconception care in women with diabetes on health outcomes for mothers and their infants.
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2017) and reference lists of retrieved articles.
Randomised controlled trials (RCTs) assessing the effects of preconception care for diabetic women. Cluster-RCTs and quasi-RCTs were eligible for inclusion but none were identified.
Two reviewers independently assessed study eligibility, extracted data and assessed the risk of bias of the included studies. We checked data for accuracy and assessed the quality of the evidence using the GRADE approach.
We included three trials involving 254 adolescent girls with type 1 or type 2 diabetes, with an overall unclear to high risk of bias. The three trials were conducted at diabetes clinics in the USA, and assessed the READY-Girls (Reproductive-health Education and Awareness of Diabetes in Youth for Girls) programme versus standard care.Considering primary outcomes, one trial reported no pregnancies in the trial period (12 months) (very low-quality evidence, with downgrading based on study limitations (risk of bias) and imprecision); in the other two trials, pregnancy was an exclusion criterion, or was not clearly reported on. None of the trials reported on the other primary maternal outcomes, hypertensive disorders of pregnancy and caesarean section; or primary infant outcomes, large-for-gestational age, perinatal mortality, death or morbidity composite, or congenital malformations. Similarly, none of the trials reported on the secondary outcomes, for which we had planned to assess the quality of the evidence using the GRADE approach (maternal: induction of labour; perineal trauma; gestational weight gain; long-term cardiovascular health; infant: adiposity; type 1 or 2 diabetes; neurosensory disability).The majority of secondary maternal and infant outcomes, and outcomes relating to the use and costs of health services were not reported by the three included trials. Regarding behaviour changes associated with the intervention, in one trial, participants in the preconception care group had a slightly higher score for the actual initiation of discussion regarding preconception care with healthcare providers at follow-up (nine months), compared with those in the standard care group (mean difference 0.40, 95% confidence interval -0.02 to 0.82 (on a scale of 0 to 4 points); participants = 87) (a summation of four dichotomous items; possible range 0 to 4, with 0 being no discussion).
AUTHORS' CONCLUSIONS: There are insufficient RCT data available to assess the effects of preconception care for diabetic women on health outcomes for mothers and their infants.More high-quality evidence is needed to determine the effects of different protocols of preconception care for diabetic women. Future trials should be powered to evaluate effects on short- and long-term maternal and infant outcomes, and outcomes relating to the use and costs of health services. We have identified three ongoing studies that we will consider in the next review update.
患有1型或2型糖尿病的母亲所生婴儿在短期内和长期内发生先天性异常、围产期死亡及严重发病的风险更高。患有糖尿病的孕妇发生围产期发病和糖尿病并发症的风险更高。血糖控制与母婴健康结局之间的关系表明,对这些女性进行孕前保健可能有益。这是对2010年首次发表的原始综述的更新。
评估糖尿病女性孕前保健对母婴健康结局的影响。
我们检索了Cochrane妊娠与分娩试验注册库(2017年1月31日)以及检索到的文章的参考文献列表。
评估糖尿病女性孕前保健效果的随机对照试验(RCT)。整群随机对照试验和半随机对照试验符合纳入标准,但未检索到相关研究。
两名综述作者独立评估研究的纳入资格、提取数据并评估纳入研究的偏倚风险。我们检查数据的准确性,并使用GRADE方法评估证据质量。
我们纳入了3项试验,涉及254名患有1型或2型糖尿病的青春期女孩,总体偏倚风险不明确至高风险。这3项试验在美国的糖尿病诊所进行,评估了“为女孩准备好(READY-Girls,青少年女孩生殖健康与糖尿病认知)”项目与标准护理的效果。考虑主要结局,一项试验报告在试验期(12个月)内无妊娠(极低质量证据,因研究局限性(偏倚风险)和不精确性而降级);在其他两项试验中,妊娠是排除标准,或未明确报告。没有一项试验报告其他主要的母亲结局,即妊娠高血压疾病和剖宫产;或主要的婴儿结局,即大于胎龄儿、围产期死亡、死亡或发病综合情况,或先天性畸形。同样,没有一项试验报告次要结局,我们原计划使用GRADE方法评估这些结局的证据质量(母亲:引产;会阴创伤;孕期体重增加;长期心血管健康;婴儿:肥胖;1型或2型糖尿病;神经感觉障碍)。纳入的3项试验未报告大多数次要的母婴结局以及与卫生服务使用和成本相关的结局。关于与干预相关的行为改变,在一项试验中,与标准护理组相比,孕前保健组的参与者在随访(9个月)时与医疗保健提供者实际开始讨论孕前保健的得分略高(平均差异0.40,95%置信区间-0.02至0.82(0至4分的量表);参与者=87)(四个二分项目的总和;可能范围0至4,0表示未讨论)。
现有RCT数据不足以评估糖尿病女性孕前保健对母婴健康结局的影响。需要更多高质量证据来确定不同糖尿病女性孕前保健方案的效果。未来的试验应有足够的样本量来评估对母婴短期和长期结局以及与卫生服务使用和成本相关结局的影响。我们已确定3项正在进行的研究,将在下一次综述更新时予以考虑。