Pharmacokinetics and modeling of betamethasone therapy in threatened preterm birth

先兆早产倍他米松治疗的药代动力学和模型

• 批准号: 10174278
• 负责人: DAVID M. HAAS
• 金额: $ 26.53万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-03-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10174278
• 关键词: Administrative Supplement; Adverse drug effect; Adverse event; Area; Betamethasone; Blood; Blood specimen; Breast Feeding; Breastfed infant; Cesarean section; Childhood; Clinical; Complement; Consent; Data; Drowsiness; Drug Kinetics; Drug Modelings; Drug Utilization; Ensure; Future; Goals; Health; Hospitals; Human Milk; Infant; Institution; Institutional Review Boards; Lactation; Life; Link; Literature; Measurement; Measures; Modeling; Mothers; Multiple Pregnancy; National Institute of Child Health and Human Development; Newborn Infant; Obstetric pharmacology; Operative Surgical Procedures; Opioid; Outcome; Pain management; Parents; Participant; Pathway interactions; Patients; Pharmaceutical Preparations; Pharmacotherapy; Population; Positioning Attribute; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Premature Birth; Procedures; Protocols documentation; Public Health; Recovery; Regimen; Reporting; Research; Safety; Specific qualifier value; Study models; Surveys; Symptoms; Therapeutic; Time; TimeLine; Umbilical Cord Blood; United States; Woman; Work; base; clinical care; cohort; experience; gabapentin; improved; medication safety; multimodality; opioid epidemic; opioid use; pediatric pharmacology; pharmacokinetic characteristic; pharmacokinetic model; postcesarean section; postoperative recovery; recruit; shared decision making; surgical pain

PROJECT SUMMARY The primary objective of this project is to characterize the pharmacokinetic distribution and safety of gabapentin in lactating women after a cesarean delivery. Given that cesarean delivery is the most common surgical procedure in the United States and that pain management after surgery is crucial to recovery, finding ways to safely and effectively manage pain and reduce opioid use is important. As many centers are now using Enhanced Recovery After Surgery protocols for women undergoing a cesarean delivery which include gabapentin as part of their multimodal pain control strategy, this project is timely and needed. Reports, including our preliminary data, indicate that gabapentin can reduce opioid use in women after cesarean delivery. While LactMed considers gabapentin to be “compatible with breastfeeding,” the data are sparse and based on few cases. A more comprehensive pharmacokinetic modeling study is needed. In addition, this proposal will add to the current literature by asking participants about side effects of the drug on their baby, notably somnolence, and will characterize postpartum opioid use at the same time, adding more safety and efficacy data for women who breastfeed. We will accomplish this proposal in the short time for the supplement because our busy labor unit is already using gabapentin for all women undergoing a cesarean delivery. We will recruit women undergoing a cesarean delivery who plan to breastfeed. Our team is experienced in consenting lactating women for pharmacokinetic studies and able to collect linked maternal blood, breast milk, and infant blood samples successfully. They also have a track record of successfully retaining cohorts of recruited women after delivery. Our analytical core lab is experienced in drug measurement for our pharmacokinetic studies in pregnant women. Our therapeutic modeling team have been creating and reporting multiple pregnancy drug models over the last several years. The team is perfectly positioned to be able to accomplish the work in this administrative supplement proposal within the time specified. This proposal complements the work of the parent R01, which also studies pharmacokinetics and individualized pharmacotherapy in pregnancy. As nearly thirty-percent of institutions using Enhanced Recovery protocols after cesarean delivery are using gabapentin, this proposal is greatly needed to ensure that as the drug is added to more pain control regimens it is safe to do so. The proposed work will fill an important gap in the literature and can serve as a cohort to follow for other childhood outcomes in the future.

项目摘要 本项目的主要目的是表征以下药物的药代动力学分布和安全性： 加巴喷丁在剖宫产术后哺乳期妇女中的应用。鉴于剖腹产是最常见的 在美国常见的外科手术，手术后的疼痛管理对于 恢复，找到安全有效地管理疼痛和减少阿片类药物使用的方法是重要的。作为 许多中心现在正在为接受手术的妇女使用增强术后恢复方案， 包括加巴喷丁作为其多模式疼痛控制策略的一部分的剖腹产，该项目 是及时的和必要的。报告，包括我们的初步数据，表明加巴喷丁可以减少 阿片类药物在剖宫产后的妇女使用。虽然LactMed认为加巴喷丁是“相容的”， 关于母乳喂养，”数据很少，而且基于很少的案例。更全面 需要进行药代动力学建模研究。此外，这项建议将增加目前的文献， 询问参与者药物对婴儿的副作用，特别是嗜睡， 同时描述产后阿片类药物的使用，为女性增加更多的安全性和有效性数据 母乳喂养的人我们会在很短的时间内完成这项建议，因为我们的 忙碌的劳动单位已经使用加巴喷丁为所有妇女进行剖腹产。我们将 招募计划进行母乳喂养的剖腹产妇女。我们的团队经验丰富， 同意进行药代动力学研究的哺乳期女性，并能够收集相关的母体血液， 母乳和婴儿血液样本他们也有一个成功的跟踪记录， 在分娩后保留招募的妇女群体。我们的分析核心实验室在药物 用于我们在孕妇中的药代动力学研究。我们的治疗模特团队 在过去的几年里，我们一直在创建和报告多胎妊娠药物模型。该团队正在 完全有能力完成本行政补充提案中的工作， 指定的时间。本建议书补充了父R01的工作，该父R01还研究 妊娠期的药代动力学和个体化药物治疗。近30%的 使用加强恢复协议的机构在剖宫产后使用加巴喷丁， 非常需要一个提案来确保这种药物在更多的疼痛控制方案中的安全性 这样做.拟议的工作将填补文献中的一个重要空白，可以作为一个队列， 在未来的其他童年成果。

项目成果

Are newborn outcomes different for term babies who were exposed to antenatal corticosteroids?

• DOI: 10.1016/j.ajog.2021.04.251
• 发表时间: 2021-11
• 期刊: American journal of obstetrics and gynecology
• 影响因子: 9.8
• 作者: McKinzie AH;Yang Z;Teal E;Daggy JK;Tepper RS;Quinney SK;Rhoads E;Haneline LS;Haas DM
• 通讯作者: Haas DM