Skip to main content
OpenTrials
Completed

NCT Number: NCT04358757

Immune and Physical Recovery Following Cesarean Delivery

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Delivery

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Stanford University

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elective cesarean delivery

Procedure

scheduled cesarean delivery for maternal / obstetric indications

Primary outcomes

  1. Incidence of immune changes from preoperative to day 1 postoperative

    Time frame: 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

  2. change in activity (measured by actigraphy) before and after cesarean

    Time frame: 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.

Secondary outcomes

  1. perioperative response to cytokine stimulation

    Time frame: preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2)

    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

  2. ex-vivo leucocyte response

    Time frame: preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2)

    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

  3. immune predictors of delayed physical recovery

    Time frame: preoperative to 6 weeks postoperative

    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.

  4. Change in ObsQoR-10

    Time frame: postoperatively on day 1 and day 2

    relationship between immune markers, actigraphy data using ObsQoR-10 (obstetric quality of recovery -10 item score- validated overall quality of recovery measure)

  5. Change in PROMIS-29 score

    Time frame: postoperatively on week 3 and 6 and 3 months

    relationship between immune markers, actigraphy data using PROMIS-29 (validated overall global health measure; patient-reported outcome measure instrument - 29 item survey)

  6. Change in EQ5D3L

    Time frame: preoperatively, postoperatively on day 1 and day 2, week 3 and 6 and 3 months

    relationship between immune markers, actigraphy data using a validated measure of global health state (EQ5D3L)

  7. Change in Edinburgh postnatal depression score (EPDS)

    Time frame: postoperatively on day 2, week 3 and 6 and 3 months

    relationship between immune markers, actigraphy data using a validated measure of depression (EPDS)

  8. Change in Pittsburgh sleep quality index

    Time frame: postoperatively on day 2, week 3 and 6 and 3 months

    relationship between immune markers, actigraphy data using a validated measure of sleep (Pittsburgh sleep index)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

An Observational Study to Determine Immune and Physical Recovery Following Elective Cesarean Delivery

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2020
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.