NCT04358757

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2023

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3.8 years

First QC Date

April 20, 2020

Last Update Submit

March 19, 2024

Conditions

Cesarean Delivery

Keywords

elective cesarean deliverypredictorsrecovery

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    2 weeks pre to 6 weeks postoperative

Secondary Outcomes (8)

  • perioperative response to cytokine stimulation

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

  • ex-vivo leucocyte response

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

  • immune predictors of delayed physical recovery

    preoperative to 6 weeks postoperative

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Cesarean patients

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

Procedure: Elective cesarean delivery

Interventions

Elective cesarean deliveryPROCEDURE

scheduled cesarean delivery for maternal / obstetric indications

Cesarean patients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsElective cesarean delivery
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women delivering via scheduled cesarean delivery

You may qualify if:

  • 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

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Leucocytes collected will be batch stored and then analysed once al samples collated after study recruitment completed.

Study Officials

  • Pervez Sultan, MBChB, FRCA, MD(Res)

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

November 22, 2019

Primary Completion

September 23, 2023

Study Completion

December 23, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)