- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05514431
Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: DPE v CSE v Epidural
Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: Dural Puncture Epidural vs Combined Spinal Epidural vs Epidural
Study Overview
Status
Conditions
Detailed 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.
- Type of neuraxial block
- Size of needle used for DPE or CSE: 25 g or 27 g
- Duration of time from epidural placement until CD (Time of epidural placement; time of delivery)
- Number of epidural top-ups
- Type and amount of medication used for conversion to surgical anesthesia
- Urgency of cesarean delivery
- Airway documentation indicative of general anesthesia (if applicable)
- Length (time) of surgical procedure
Other data collected from patient electronic records will include:
- Maternal demographics: Parity, number of prior cesarean deliveries, weight, height, BMI
- Fetal characteristics (birthweight, Apgar scores)
Indication for cesarean delivery
- Fetal distress (NRFHT, fetal intolerance of labor)
- Failure of labor (Failure to dilate, failure to descend)
- Failed operative vaginal delivery
- Maternal comorbidity
- Emergency (cord prolapse, abruption, uterine rupture)
- Anesthesiologist (Fellowship trained: Y/N) at time of cesarean delivery
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- BC Women's Hospital
-
-
-
-
Minnesota
-
Rochester, Minnesota, United States, 55902
- Mayo Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women with neuraxial labor analgesia (CSE, DPE, or Epidural) who have an intrapartum cesarean delivery
- Singleton gestation
Exclusion Criteria:
- No local anesthetic given in epidural for cesarean delivery (in emergency situation)
- Inadvertent dural puncture
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Dural puncture epidural (DPE)
Subjects that received neuraxial labor analgesia of dural puncture epidural for intrapartum cesarean delivery
|
Epidural catheters placed via DPE technique
|
|
Combined spinal epidural (CSE)
Subjects that received neuraxial labor analgesia of combined spinal epidural for intrapartum cesarean delivery
|
Epidural catheters placed via CSE technique
|
|
Traditional Epidural
Subjects that received neuraxial labor analgesia of epidural for intrapartum cesarean delivery
|
Traditional epidural catheter placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conversion to surgical anesthesia
Time Frame: Baseline
|
Number of subject to have success of conversion to surgical anesthesia for intrapartum cesarean delivery
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Sharpe, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Agnosia
- Investigative Techniques
- Therapeutics
- Drug Administration Routes
- Drug Therapy
- Injections
- Injections, Spinal
- Methods
- Injections, Epidural
Other Study ID Numbers
- 20-004677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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