Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05514431 |
| Other study ID # |
20-004677 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2017 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
August 2023 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
As the dural puncture epidural (DPE) is increasing in popularity for labor analgesia, it is
important to understand how it impacts outcomes in parturients. Prior studies have found
epidural catheters placed via the combined-spinal epidural technique have greater success at
surgical conversion for cesarean delivery than catheters placed via traditional techniques.
The investigators aim to determine if epidural catheters placed by a DPE technique will also
have an increased successful conversion for surgical anesthesia by conducting a retrospective
review of all CD during the study period. If an association is found, this could be another
benefit of DPE for labor analgesia.
Description:
Electronic medical records will be searched for all intrapartum cesarean deliveries performed
from February 1, 2017 through May 30, 2021 (Mayo Clinic) and from January 1, 2022 to December
31, 2022 (BC Women's Hospital).
From this list, patients that had cesarean delivery with an epidural catheter will be
identified and split into three groups based on the type of neuraxial block listed in the
block document of the patient's medical record:
Group 1 - Dural puncture epidural Group 2 - Epidural Group 3 - Combined spinal-epidural
Failure of epidural catheter conversion to surgical anesthesia at cesarean delivery will be
defined by requirement of a second anesthetic at the time of surgery, including spinal or
repeat epidural techniques or general anesthesia at the time of cesarean delivery
Data Collection: All data will be collected retrospectively from the electronic medical
record.
1. Type of neuraxial block
2. Size of needle used for DPE or CSE: 25 g or 27 g
3. Duration of time from epidural placement until CD (Time of epidural placement; time of
delivery)
4. Number of epidural top-ups
5. Type and amount of medication used for conversion to surgical anesthesia
6. Urgency of cesarean delivery
7. Airway documentation indicative of general anesthesia (if applicable)
8. Length (time) of surgical procedure
Other data collected from patient electronic records will include:
1. Maternal demographics: Parity, number of prior cesarean deliveries, weight, height, BMI
2. Fetal characteristics (birthweight, Apgar scores)
3. Indication for cesarean delivery
1. Fetal distress (NRFHT, fetal intolerance of labor)
2. Failure of labor (Failure to dilate, failure to descend)
3. Failed operative vaginal delivery
4. Maternal comorbidity
5. Emergency (cord prolapse, abruption, uterine rupture)
4. Anesthesiologist (Fellowship trained: Y/N) at time of cesarean delivery
