Medically-supervised withdrawal vs. agonist maintenance in the treatment of pregnant women with opioid use disorder: Maternal, fetal, and neonatal outcomes

项目概要/摘要 背景阿片类激动剂治疗（OAT）和反对医疗监督的建议 停药（MSW）是基于早期报告，将停药与母亲复发和胎儿 死亡虽然我们最近的系统评价并不支持MSW和胎儿死亡之间的关联， 复发仍然是一个重要的问题，复发率为0%至100%。一份回顾性报告还 表明与OAT相比，使用MSW分娩时的分娩并发症更多。术后新生儿结局 然而，母亲MSW更积极，回顾性报告表明MSW降低了 新生儿戒断综合征（NAS）的发病率，减少治疗NAS所需的药物量， 与OAT相比，缩短了新生儿住院时间。鉴于文献的混合结果和 方法上的缺陷，需要前瞻性的对照研究。 研究设计.拟定的研究将是一项四中心、对照、前瞻性、纵向、匹配队列研究 在一项研究中，在治疗开始时选择MSW的OUD孕妇（n=120）将倾向于 评分与在治疗开始时选择OAT的OUD孕妇匹配（n=240），使用母体 研究入组时收集的人口统计学、社会、个人和物质使用史数据。女性选择 MSW将使用丁丙诺啡进行5-7天的停药;那些选择OAT的人将被引导到 丁丙诺啡所有人都将得到全面的临床护理（产科就诊，团体和个人 咨询、病例管理、精神病学服务和尿液药物筛查），并每月完成 与研究人员一起进行研究评估。将对产妇和新生儿健康进行全面评估， 出生时的幸福感，至少4天的NAS评估和产妇产后评估。 目的1：（探索性）确定寻求MSW的OUD孕妇与 那些寻求OAT的人在人口统计学，社会，个人和物质使用历史特征方面。 目标2：（推理）检查患有OUD的孕妇寻求MSW的程度与 就产妇和新生儿结局而言寻求OAT的人。目标3。（描述性）评估能力 参与者治疗进入特征的差异，以区分（a）成功的MSW参与者 完成他们的退出方案，从MSW参与者谁不;（B）MSW参与者， 成功完成MSW，并且在从成功完成MSW的MSW参与者交付时为阿片样物质阴性， 完成其退出方案，但停止治疗，并且在分娩时为阿片样物质阳性;以及（c） 成功完成MSW并且在分娩时为阿片样物质阴性的参与者， 保持在OAT中，并且在分娩时阿片类药物呈阴性。公共卫生影响。这项研究将提供科学- 基于证据，解决妊娠期间OUD治疗的重大差距， 政府、医学会、医疗服务提供者和患者向母亲和新生儿提供治疗信息。

PROJECT SUMMARY/ABSTRACT Background. Recommendations for opioid agonist treatment (OAT) and against medically-supervised withdrawal (MSW) were based on early reports associating withdrawal with maternal relapse and fetal demise. While our recent systematic review did not support an association between MSW and fetal demise, relapse remains a significant concern with rates ranging from 0% to 100%. A retrospective report also suggests more delivery complications at delivery with MSW as compared to OAT. Neonatal outcomes after maternal MSW, however, are more positive, with retrospective reports suggesting MSW decreases the incidence of neonatal abstinence syndrome (NAS), reduces the amount of medication needed to treat NAS, and shortens neonatal length of hospital stay as compared to OAT. Given the literature’s mixed findings and methodological weaknesses, controlled prospective studies are needed. Study Design. The proposed study will be a four site, controlled, prospective, longitudinal, matched cohort study in which pregnant women with OUD who choose MSW at treatment entry (n=120) will be propensity- score matched with pregnant women with OUD who choose OAT at treatment entry (n=240) using maternal demographic, social, personal, and substance use history data collected at study entry. Women choosing MSW will undergo a 5-7 day withdrawal using buprenorphine; those choosing OAT will be inducted onto buprenorphine. All will receive comprehensive clinical care (obstetrical visits, group and individual counseling, case management, psychiatry services, and urine drug screening) and complete monthly research assessments with study staff. There will be a full assessment of maternal and neonatal health and well-being at birth, a minimum 4-day assessment of NAS, and a maternal postpartum assessment. Aim 1: (Exploratory) To determine the extent to which pregnant women with OUD seeking MSW differ from those seeking OAT in terms of demographic, social, personal, and substance use history characteristics. Aim 2: (Inferential) To examine the extent to which pregnant women with OUD seeking MSW differ from those seeking OAT in terms of maternal and neonatal outcomes. Aim 3. (Descriptive) To assess the ability of participant treatment entry characteristics to discriminate between (a) MSW participants who successfully complete their withdrawal protocol from MSW participants who do not; (b) MSW participants who successfully complete MSW and are opioid-negative at delivery from MSW participants who successfully complete their withdrawal protocol but discontinue treatment and are opioid-positive at delivery; and (c) participants who successfully complete MSW and are opioid-negative at delivery from participants who remain in OAT and are opioid-negative at delivery. Public Health Impact. This study will provide science- based evidence that addresses significant gaps in the treatment of OUD during pregnancy to be used by government, medical societies, providers and patients to inform treatment of mothers and neonates.