Hughes Ruth C E, Rowan Janet, Williman Jonathan
Department of Obstetrics and Gynaecology, University of Otago, Christchurch, New Zealand.
Department of Obstetrics, National Women's Health, Auckland, New Zealand.
BMJ Open. 2018 Mar 3;8(3):e018493. doi: 10.1136/bmjopen-2017-018493.
Measurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes.
Two tertiary referral centres in New Zealand.
Women <14 weeks' gestation and HbA1c ≥5.9%-6.4% (41-46 mmol/mol) measured at booking, without pre-existing diabetes.
Randomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks' gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy.
Recruitment rate, adherence to protocol and validation of potential primary outcomes.
Recruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement.
For a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and healthcare costs.
ACTRN12615000904572; Pre-results.
在新西兰，孕早期测量糖化血红蛋白（HbA1c）是识别糖尿病和糖尿病前期女性的常规检查。然而，对糖尿病前期女性进行早期干预的益处尚无定论。我们的目的是测试一项双臂平行随机对照试验的可行性，该试验比较了对合并糖尿病前期的妊娠进行标准护理与早期干预的效果。
新西兰的两家三级转诊中心。
妊娠<14周且在初次产检时测得HbA1c≥5.9%-6.4%（41-46 mmol/mol）、无糖尿病史的女性。
通过基于网络的远程分配将参与者随机分为两组。早期干预组的女性参加产前糖尿病门诊，开始每日家庭血糖监测，若生活方式干预未能维持目标血糖水平则开具药物治疗。对照组接受生活方式教育，继续由助产士和/或产科医生提供标准护理，并被要求在妊娠24周时进行75克口服葡萄糖耐量试验，若该试验结果为阳性则转诊至门诊。两组在招募时和妊娠晚期均接受生活方式问卷调查。
招募率、对方案的依从性以及对潜在主要结局的验证。
招募率低于预期，尤其是在毛利族和太平洋岛族女性中。对分配的治疗方案的不依从情况显著，早期干预组为42%（95%CI 24%至61%），对照组为30%（95%CI 16%至51%）。由于对照组中观察到的高发生率以及易于测量，剖宫产和子痫前期被视为潜在的主要结局。
对于未来的确定性试验，延长符合条件的孕周并采用阶梯式整群随机化可能会克服已发现的可行性问题。与已发表的观察性数据一致，子痫前期和急诊剖宫产可作为主要结局指标，这两者对孕产妇和新生儿发病率以及医疗费用均有重大影响。
ACTRN12615000904572；预结果。
