Immune and Physical Recovery Following Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-22

Study Completion Date

2023-12-23

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cesarean Delivery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cesarean patients

participants undergoing elective cesarean will have measures of recovery assessed (patient-reported outcome measures and activity data from watch)

Elective cesarean delivery

Intervention Type PROCEDURE

scheduled cesarean delivery for maternal / obstetric indications

Interventions

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Elective cesarean delivery

scheduled cesarean delivery for maternal / obstetric indications

Intervention Type PROCEDURE

Eligibility Criteria

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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