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

治疗患有阿片类药物使用障碍的孕妇的医学监督戒断与激动剂维持治疗：孕产妇、胎儿和新生儿结局

• 批准号: 9903275
• 负责人: Sarah H Heil
• 金额: $ 65.8万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9903275
• 关键词: Abruptio Placentae; Academic Medical Centers; Address; Agonist; Alcohol or Other Drugs use; Birth; Body Size; Buprenorphine; Case Management; Characteristics; Clinic; Cohort Studies; Comprehensive Health Care; Counseling; Data; Discipline of obstetrics; Drug Metabolic Detoxication; Drug Screening; Exposure to; Family; Government; Health; Health Services; Incidence; Individual; Length; Length of Stay; Literature; Maintenance; Medical; Medical Societies; Methodology; Morphine; Mothers; Neonatal; Neonatal Abstinence Syndrome; Opioid; Outcome; Participant; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pharmacological Treatment; Policies; Population; Postpartum Period; Pregnancy; Pregnant Women; Premature Birth; Prospective Studies; Protocols documentation; Provider; Psychiatry; Public Health; Recommendation; Recording of previous events; Relapse; Reporting; Research; Research Design; Safety; Science; Services; Site; Social Work; Supervision; Urine; Visit; Withdrawal; Woman; base; clinical care; common treatment; delivery complications; disorder later incidence prevention; evidence base; fetal; follow-up; high risk population; innovation; intraamniotic infection; maternal outcome; neonatal outcome; neonate; opioid agonist therapy; opioid use disorder; opioid withdrawal; preference; prenatal exposure; pressure; prospective; recruit; response; social; social factors; standard of care; systematic review; treatment comparison; treatment group

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.

项目摘要/摘要 背景资料。对阿片类激动剂治疗(OAT)和反对医疗监督的建议 戒断(MSW)是基于早期报告，将戒断与母亲复发和胎儿 死亡。虽然我们最近的系统回顾并不支持城市生活垃圾和胎儿死亡之间的联系， 复发仍然是一个令人严重担忧的问题，发病率从0%到100%不等。一份回顾报告也 提示与燕麦片相比，使用MSW分娩时出现更多的分娩并发症。术后新生儿结局 然而，母亲的MSW更积极，回顾报告表明，MSW降低了 新生儿禁欲综合征(NAS)的发生率，减少了治疗NAS所需的药量， 与燕麦片相比，可缩短新生儿住院时间。鉴于文献中各种不同的发现， 方法上的缺陷，需要有对照的前瞻性研究。 研究设计。拟议的研究将是一项四点对照、前瞻性、纵向、配对队列研究 在这项研究中，患有城市生活垃圾的孕妇在治疗开始时选择城市生活垃圾(n=120)的倾向将是- 与在治疗开始时选择燕麦片的患有OUD的孕妇相匹配的分数(n=240) 在研究开始时收集的人口、社会、个人和物质使用历史数据。女性选择 MSW将使用丁丙诺啡进行5-7天的停药；选择燕麦片的人将被诱导到 丁丙诺啡。所有人都将接受全面的临床护理(产科探视、团体和个人 咨询、病例管理、精神科服务和尿液药物筛查)，每月完成 与研究人员一起进行研究评估。将对孕产妇和新生儿健康进行全面评估，并 出生时的幸福感，NAS的最低4天评估，以及产妇产后评估。 目标1：(探索性)确定寻求城市生活垃圾的孕妇与 那些在人口、社会、个人和物质方面寻求燕麦片的人使用历史特征。 目标2：(推论)检查患有城市生活垃圾的孕妇在多大程度上与 那些寻求燕麦片治疗的孕妇和新生儿的结局。目标3.(描述性)评估能力 参与者治疗进入特征，以区分(A)成功地 完成没有退出的MSW参与者的退出方案；(B)MSW参与者 成功完成MSW，且MSW参与者在分娩时阿片类药物阴性 完成他们的戒断方案，但停止治疗，并且在分娩时阿片类药物呈阳性；和(C) 成功完成MSW并在分娩时阿片类药物阴性的参与者 留在燕麦片中，在分娩时是阿片类药物阴性。公共卫生影响。这项研究将提供科学- 基于证据，解决了妊娠期OUD治疗中的重大差距，供 向政府、医学会、提供者和病人通报母亲和新生儿的治疗情况。