Effect of antenatal milk expression education on lactation outcomes in birthing people with pre-pregnancy body mass index ≥25: protocol for a randomized, controlled trial.
Effect of antenatal milk expression education on lactation outcomes in birthing people with pre-pregnancy body mass index ≥25: protocol for a randomized, controlled trial.
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DOI：
10.1186/s13006-023-00552-6
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发表时间：
2023-03-16
影响因子：
3.5
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中科院分区：
文献类型：
--
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孕前体重指数（BMI）≥ 25 kg/m2的分娩人群，特别是那些没有母乳喂养经验的人，其哺乳结局不佳的风险增加。母乳挤出（AME）可能是抵消这一人群中常见的早期婴儿配方奶粉补充剂负面影响的一种方法。这项正在美国进行的随机对照试验在280名孕前BMI ≥ 25 kg/m2的未产妇至经产妇、非糖尿病分娩人群中评估了远程哺乳提供的AME教育干预与注意力控制条件对产后1年哺乳结局的有效性。指定的研究治疗在妊娠37-40周之间通过每周四次的在线视频咨询进行。分配到AME的参与者与研究人员和哺乳顾问会面，学习和实践AME。提供了研究访视之间AME家庭实践的说明。对照组参与者在研究访视时观看婴儿护理/发育视频。参与者在入组时（340/7-366/7孕周）和产后2周、6周、12周、6个月和12个月完成电子邮件调查。调查评估哺乳和婴儿喂养的做法;母乳喂养的自我效能，态度和满意度;对牛奶不足的看法;催乳II的发病;哺乳支持和问题;以及停止母乳喂养的原因。调查还评估了与哺乳结果相关的因素，包括人口统计学特征、健康问题、出生创伤、种族歧视和体重耻辱。健康信息和婴儿喂养数据从妊娠和分娩中心电子健康记录中提取。在每次研究访视时从干预组收集乳汁样品，并在每次产后随访时从两组收集乳汁样品用于未来分析。产后6周进行定性访谈，了解AME的经验。主要研究结果是产后2周母乳喂养的排他性和母乳喂养自我效能评分。将采用广义线性混合效应模型对结局进行纵向检查。这是第一项充分评估AME在美国分娩人群和孕前BMI ≥ 25 kg/m2的非糖尿病人群中的有效性的试验。这项研究还将提供远程遥控AME的可接受性和有效性的第一个证据。ClinicalTrials.gov：NCT 04258709。
Birthing people with pre-pregnancy body mass indices (BMIs) ≥ 25 kg/m2, particularly those without prior breastfeeding experience, are at increased risk for suboptimal lactation outcomes. Antenatal milk expression (AME) may be one way to counteract the negative effects of early infant formula supplementation common in this population. This ongoing, randomized controlled trial in the United States evaluates the efficacy of a telelactation-delivered AME education intervention versus an attention control condition on lactation outcomes to 1 year postpartum among 280 nulliparous-to-primiparous, non-diabetic birthing people with pre-pregnancy BMI ≥ 25 kg/m2. The assigned study treatment is delivered via four weekly online video consultations between gestational weeks 37–40. Participants assigned to AME meet with study personnel and a lactation consultant to learn and practice AME. Instructions are provided for home practice of AME between study visits. Control group participants view videos on infant care/development at study visits. Participants complete emailed surveys at enrollment (340/7–366/7 gestational weeks) and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postpartum. Surveys assess lactation and infant feeding practices; breastfeeding self-efficacy, attitudes, and satisfaction; perception of insufficient milk; onset of lactogenesis-II; lactation support and problems; and reasons for breastfeeding cessation. Surveys also assess factors associated with lactation outcomes, including demographic characteristics, health problems, birth trauma, racial discrimination, and weight stigma. Health information and infant feeding data are abstracted from the pregnancy and birth center electronic health record. Milk samples are collected from the intervention group at each study visit and from both groups at each postpartum follow-up for future analyses. Qualitative interviews are conducted at 6 weeks postpartum to understand AME experiences. Primary outcomes of interest are breastfeeding exclusivity and breastfeeding self-efficacy scores at 2 weeks postpartum. Outcomes will be examined longitudinally with generalized linear mixed-effects modeling. This is the first adequately powered trial evaluating the effectiveness of AME among U.S. birthing people and within a non-diabetic population with pre-pregnancy BMI ≥ 25 kg/m2. This study will also provide the first evidence of acceptability and effectiveness of telelactation-delivered AME. ClinicalTrials.gov: NCT04258709.
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168.9
作者：
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