Pharmacokinetics and modeling of betamethasone therapy in threatened preterm birth

项目总结

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.