Clinical Trials Logo

Clinical 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 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04358757
Study type Observational
Source Stanford University
Contact
Status Completed
Phase
Start date November 22, 2019
Completion date December 23, 2023

See also
  Status Clinical Trial Phase
Completed NCT03236324 - Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery Phase 2
Recruiting NCT04058444 - The First ERAS Protocol for Cesarean Delivery in Serbia at the University Hospital N/A
Completed NCT03150641 - Delayed Cord Clamping at Term Cesarean N/A
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT02846129 - Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery N/A
Completed NCT00799955 - Comparing 2 Types of Pain Relief After Cesarean Delivery: Spinal Morphine and TAP Block N/A
Completed NCT03336541 - Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression Phase 4
Completed NCT01755026 - Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery Phase 4
Recruiting NCT03746678 - Patient-Centred Perioperative Mobile Application
Completed NCT03349151 - Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery N/A
Completed NCT03729076 - Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia N/A
Completed NCT04799587 - Accupressure of P6 to Reduce Nausea During Cesarean Section N/A
Not yet recruiting NCT05758012 - Carbetocin Compared To Oxytocin During Cesarean Delivery
Completed NCT03781388 - ED90 for Hyperbaric Bupivacaine in Super Obese Parturients Phase 4
Completed NCT04349215 - Validation of the Chinese ObsQoR-11
Completed NCT04812223 - Timing of Umbilical Cord Clamping in Term Cesarean Deliveries N/A
Recruiting NCT05279703 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery Phase 4
Completed NCT01550640 - Pharmacogenetics of Remifentanil in Patients With Hypertension Undergoing Cesarean Delivery Under General Anesthesia N/A
Completed NCT00884026 - Can Augmentation Index (AIx) be Used to Predict Hypotension After Spinal Anesthesia? N/A
Completed NCT03830307 - NSS-Bridge Device for Post-Cesarean Delivery Pain N/A