An observational study in Cesarean Delivery, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Stanford University · Observational
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).
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.
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women delivering via scheduled cesarean delivery
Exclusion Criteria:
participants undergoing elective cesarean will have measures of recovery assessed (patient-reported outcome measures and activity data from watch)
Procedure: Elective cesarean delivery
scheduled cesarean delivery for maternal / obstetric indications
Incidence of immune changes from preoperative to day 1 postoperative
immune changes include: leukocyte subset distribution, intracellular signaling pathway activity within leukocyte subsets and cytokine-induced responses to ex-vivo stimulation in leukocyte subsets
Time frame: immediately prior to surgery versus morning following surgery (approximately 24 hrs apart)
change in activity (measured by actigraphy) before and after cesarean
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.
Time frame: 2 weeks pre to 6 weeks postoperative
perioperative response to cytokine stimulation
cytokine stimulation of leucocytes from parturients will be assessed using mass cytometry. blood samples will be taken from all participants preoperatively and on morning following surgery. 10 women will also have: postanesthetic care unit blood, umbilical vein blood and day 2 blood samples taken
Time frame: preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2)
ex-vivo leucocyte response
Leucocytes will be chemically stimulated ex-vivo for each leukocyte subset, plot stimulated and unstimulated levels and delta (change) in levels at each time point 10 women will also have: postanesthetic care unit blood, umbilical vein blood and day 2 blood samples taken
Time frame: preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2)
immune predictors of delayed physical recovery
phenotype (immune profile) associated with delayed physical recovery. determine whether any preoperative immune phenotype (preoperative changes in immune response to chemical stressors) can predict worse activity profiles analysed using actigraph data.
Time frame: preoperative to 6 weeks postoperative
Change in ObsQoR-10
relationship between immune markers, actigraphy data using ObsQoR-10 (obstetric quality of recovery -10 item score- validated overall quality of recovery measure)
Time frame: postoperatively on day 1 and day 2
Change in PROMIS-29 score
relationship between immune markers, actigraphy data using PROMIS-29 (validated overall global health measure; patient-reported outcome measure instrument - 29 item survey)
Time frame: postoperatively on week 3 and 6 and 3 months
Change in EQ5D3L
relationship between immune markers, actigraphy data using a validated measure of global health state (EQ5D3L)
Time frame: preoperatively, postoperatively on day 1 and day 2, week 3 and 6 and 3 months
Change in Edinburgh postnatal depression score (EPDS)
relationship between immune markers, actigraphy data using a validated measure of depression (EPDS)
Time frame: postoperatively on day 2, week 3 and 6 and 3 months
Change in Pittsburgh sleep quality index
relationship between immune markers, actigraphy data using a validated measure of sleep (Pittsburgh sleep index)
Time frame: postoperatively on day 2, week 3 and 6 and 3 months
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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