Cesarean DeliveryNCT04358757
Immune and Physical Recovery Following Cesarean Delivery
An observational study of Cesarean Delivery, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- Elective cesarean delivery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 23 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: women delivering via scheduled cesarean delivery
Who may be able to join
- 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,
Show all 10Show fewer
- 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
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study to Determine Immune and Physical Recovery Following Elective 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).
Read the 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.
- Conditions
- Cesarean Delivery
- Being tested
- Elective cesarean delivery
- Keywords
- elective cesarean delivery, predictors, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective cesarean deliveryProcedure or surgery
scheduled cesarean delivery for maternal / obstetric indications
| Study group | Role | What they receive |
|---|---|---|
| Cesarean patients | participants undergoing elective cesarean will have measures of recovery assessed (patient-reported outcome measures and activity data from watch) Receives: Procedure: Elective cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 weeks pre to 6 weeks postoperative
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: postoperatively on day 2, week 3 and 6 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start22 Nov 2019
- Primary completion23 Sep 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PSultan, Stanford University
- Investigators
- Pervez Sultan, MBChB, FRCA, MD(Res), Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358757
- Sponsor's protocol ID
- 51414
- Status last verified
- Mar 2024
- First submitted
- 20 Apr 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine Immune and Physical Recovery Following Elective Cesarean Delivery
- ClinicalTrials.gov ID
- NCT04358757
- Acronym / sponsor ID
- 51414
- Conditions
- Cesarean Delivery
- Keywords
- elective cesarean delivery, predictors, recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean patients | – | Procedure: Elective cesarean deliveryparticipants undergoing elective cesarean will have measures of recovery assessed (patient-reported outcome measures and activity data from watch) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women delivering via scheduled cesarean delivery
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective cesarean deliveryscheduled cesarean delivery for maternal / obstetric indications | Procedure or surgery | Cesarean patients |
Primary outcome
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
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.
8 secondary outcomes
perioperative response to cytokine stimulation
Time frame: preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2)
ex-vivo leucocyte response
Time frame: preoperative, day 1 (and in a subset PACU, umbilical vein, and day 2)
immune predictors of delayed physical recovery
Time frame: preoperative to 6 weeks postoperative
Change in ObsQoR-10
Time frame: postoperatively on day 1 and day 2
Change in PROMIS-29 score
Time frame: postoperatively on week 3 and 6 and 3 months
Change in 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)
Time frame: postoperatively on day 2, week 3 and 6 and 3 months
Change in Pittsburgh sleep quality index
Time frame: postoperatively on day 2, week 3 and 6 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Cesarean Delivery
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pervez Sultan, MBChB, FRCA, MD(Res) principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Delivery, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of immune changes from preoperative to day 1 postoperative (time frame: immediately prior to surgery versus morning following surgery (approximately 24 hrs apart)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.