Clinical trial NCT04358757: Immune and Physical Recovery Following Cesarean Delivery
Official title: An Observational Study to Determine Immune and Physical Recovery Following Elective Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Delivery
Keywords: elective cesarean delivery
predictors
recovery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women delivering via scheduled cesarean delivery

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 2.
* 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

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Incidence of immune changes from preoperative to day 1 postoperative
timeFrame: immediately prior to surgery versus morning following surgery (approximately 24 hrs apart)
measure: change in activity (measured by actigraphy) before and after cesarean
timeFrame: 2 weeks pre to 6 weeks postoperative
Secondary outcomes:
measure: perioperative response to cytokine stimulation
timeFrame: preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2)
measure: ex-vivo leucocyte response
timeFrame: preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2)
measure: immune predictors of delayed physical recovery
timeFrame: preoperative to 6 weeks postoperative
measure: Change in ObsQoR-10
timeFrame: postoperatively on day 1 and day 2
measure: Change in PROMIS-29 score
timeFrame: postoperatively on week 3 and 6 and 3 months
measure: Change in EQ5D3L
timeFrame: preoperatively, postoperatively on day 1 and day 2, week 3 and 6 and 3 months
measure: Change in Edinburgh postnatal depression score (EPDS)
timeFrame: postoperatively on day 2, week 3 and 6 and 3 months
measure: Change in Pittsburgh sleep quality index
timeFrame: postoperatively on day 2, week 3 and 6 and 3 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Pervez Sultan, MBChB, FRCA, MD(Res)
role: PRINCIPAL_INVESTIGATOR
References: