An Observational Study to Determine Immune and Physical Recovery Following Elective Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of immune changes from preoperative to day 1 postoperative
研究概览
简要总结
Pregnancy results in an altered immune state compared to the nonpregnant population. A significant proportion of women undergoing cesarean delivery recover poorly. The first step to determining whether this is an immune driven / associated process is to characterise what effects this surgery has on maternal immune function. "Normal" changes will be evaluated in maternal immune function and activity precipitated by surgery and delivery of the neonate. Immune response to surgery will be compared to historical immune data from patients undergoing non-obstetric surgery (orthopaedic patients).
详细描述
Variations will be evaluated in baseline and postpartum leukocyte subset distribution and singling pathways within leukocyte subsets (including response to surgery) in women undergoing elective cesarean delivery compare to patients undergoing nonobstetric surgery (orthopaedic data from a completed study). This will help to determine whether baseline immune function and response to trauma (surgery) is the same in the pregnant and non-pregnant states. Women will also be evaluated for clinical recovery parameters using validated scoring measures and objective measurement of physical activity through use of a smartwatch (actigraph) around the peripartum period. This information is of significant importance as it brings us one step closer to identifying immune mechanisms that may be involved in or associated with poorer postpartum recovery.
Aim- to determine whether perioperative immune function can predict women who are likely to have delayed physical recovery or recover poorly as demonstrated by lower scores on subjective clinical questionnaires and collected via watch actigraphy. This will help to determine whether a pre-existing deficient immune state is responsible for a worse recovery profile, which could be identified preoperatively. Similarly whether an impairment in response to surgery is demonstrable, which predisposes women to worse recovery profiles will be evaluated.
Ultimately, earlier identification of at-risk parturients (for example, through a preoperative bedside test) may lead to earlier interventions / patient centred care, in an attempt to improve their recovery trajectory and patient experience.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective cesarean delivery at Lucile Packard Hospital
- •age >20 to <50 years old,
- •single pregnancy term
- •gestational age 37-41 weeks pregnancy,
- •elective cesarean delivery,
- •spinal or combined spinal-epidural anesthesia as primary anesthesia mode,
- •multimodal analgesia regimen (including intrathecal morphine and regular acetaminophen and NSAIDs), single center at Stanford.
- •ASA grade 1 or
- •gestational diabetes (not requiring insulin or diabetes medications and pre-eclampsia (without severe features) will be included.
- •ethnic background: all ethnic backgrounds will be included gender: pregnant women only
排除标准
- •refusal to participate
结局指标
主要结局
Incidence of immune changes from preoperative to day 1 postoperative
时间窗: immediately prior to surgery versus morning following surgery (approximately 24 hrs apart)
immune changes include: leukocyte subset distribution, intracellular signaling pathway activity within leukocyte subsets and cytokine-induced responses to ex-vivo stimulation in leukocyte subsets
change in activity (measured by actigraphy) before and after cesarean
时间窗: 2 weeks pre to 6 weeks postoperative
Actigraph smartwatch data will be used to assess how activity changes around the time of delivery and determine physical recovery profiles following elective cesarean delivery. Time to baseline and time to plateau of maximal physical activity will be assessed in the postpartum period up to 6 weeks postoperatively.
次要结局
- perioperative response to cytokine stimulation(preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2))
- Change in ObsQoR-10(postoperatively on day 1 and day 2)
- Change in PROMIS-29 score(postoperatively on week 3 and 6 and 3 months)
- Change in EQ5D3L(preoperatively, postoperatively on day 1 and day 2, week 3 and 6 and 3 months)
- ex-vivo leucocyte response(preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2))
- Change in Pittsburgh sleep quality index(postoperatively on day 2, week 3 and 6 and 3 months)
- immune predictors of delayed physical recovery(preoperative to 6 weeks postoperative)
- Change in Edinburgh postnatal depression score (EPDS)(postoperatively on day 2, week 3 and 6 and 3 months)
研究者
PSultan
Associate Professor
Stanford University
