Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial
Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial
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DOI：
10.1016/s0140-6736(17)31373-9
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发表时间：
2017-06-03
期刊：
影响因子：
168.9
通讯作者：
Amir, Lisa H.
中科院分区：
文献类型：
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作者：
Forster, Della A.;Moorhead, Anita M.;Amir, Lisa H.
妊娠期糖尿病妇女的婴儿发生低血糖、进入新生儿重症监护室（NICU）以及非纯母乳喂养的风险增加。许多临床医生鼓励患有糖尿病的孕妇在怀孕后期挤出和储存母乳，但没有证据表明这种做法。我们的目的是确定产前表达的安全性和有效性，在妇女与糖尿病pregnancy.Methods我们做了一个多中心，两组，非盲，随机对照试验，在6家医院在维多利亚，澳大利亚。我们招募了在妊娠34 - 37周的单胎妊娠中有既往糖尿病或妊娠期糖尿病的妇女，并将她们随机分配（1：1）从妊娠36周开始每天两次挤奶（产前挤奶）或标准护理（常规助产和产科护理，辅以糖尿病教育者的支持）。使用计算机化随机数发生器在大小为2和4的区组中进行随机化，并按研究中心、产次和糖尿病类型进行分层。研究者对区组大小设盲，但不可能对护理人员设盲。主要结局是入住NICU的婴儿比例。我们按意向治疗进行分析;数据的获得和分析对组分配不知情。该试验在澳大利亚新西兰临床试验注册处注册，编号ACTRN 12611000217909。结果在2011年6月6日至2015年10月29日期间，我们招募并随机分配了635名女性：319名接受产前表达，316名接受标准护理。3例未纳入主要分析（1例退出标准治疗组，1例随机化后排除，1例退出产前表达组）。新生儿重症监护病房的婴儿比例在两组之间没有差异（46/317例[15%]分配到产前表达，44/315例[14%]分配到标准护理;调整后的相对危险度为1.06，95%CI为0.66至1.46）。在产前表达组中，婴儿最常见的严重不良事件是进入NICU进行呼吸支持（3例[
Background Infants of women with diabetes in pregnancy are at increased risk of hypoglycaemia, admission to a neonatal intensive care unit (NICU), and not being exclusively breastfed. Many clinicians encourage women with diabetes in pregnancy to express and store breastmilk in late pregnancy, yet no evidence exists for this practice. We aimed to determine the safety and efficacy of antenatal expressing in women with diabetes in pregnancy.Methods We did a multicentre, two-group, unblinded, randomised controlled trial in six hospitals in Victoria, Australia. We recruited women with pre-existing or gestational diabetes in a singleton pregnancy from 34 to 37 weeks' gestation and randomly assigned them (1:1) to either expressing breastmilk twice per day from 36 weeks' gestation (antenatal expressing) or standard care (usual midwifery and obstetric care, supplemented by support from a diabetes educator). Randomisation was done with a computerised random number generator in blocks of size two and four, and was stratified by site, parity, and diabetes type. Investigators were masked to block size but masking of caregivers was not possible. The primary outcome was the proportion of infants admitted to the NICU. We did the analyses by intention to treat; the data were obtained and analysed masked to group allocation. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000217909.Findings Between June 6, 2011, and Oct 29, 2015, we recruited and randomly assigned 635 women: 319 to antenatal expressing and 316 to standard care. Three were not included in the primary analysis (one withdrawal from the standard care group, and one post-randomisation exclusion and one withdrawal from the antenatal expressing group). The proportion of infants admitted to the NICU did not differ between groups (46 [15%] of 317 assigned to antenatal expressing vs 44 [14%] of 315 assigned to standard care; adjusted relative risk 1.06, 95% CI 0.66 to 1.46). In the antenatal expressing group, the most common serious adverse event for infants was admission to the NICU for respiratory support (for three [