AnesthesiaNCT05514431
Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: DPE v CSE v Epidural
An observational study of Anesthesia and Analgesia, run by Mayo Clinic at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Analgesia
- What is being tested?
- Epidural, Dural Puncture Epidural (DPE) technique and Combined Spinal-Epidural (CSE) technique
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2017to Jul 2027
- Phase
- Observational
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parturients that undergo intrapartum cesarean delivery with an epidural already in situ.
Who may be able to join
- Women with neuraxial labor analgesia (CSE, DPE, or Epidural) who have an intrapartum cesarean delivery
- Singleton gestation
Who cannot join
- No local anesthetic given in epidural for cesarean delivery (in emergency situation)
- Inadvertent dural puncture
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: Dural Puncture Epidural vs Combined Spinal Epidural vs Epidural
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.
Read the 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
- Conditions
- Anesthesia, Analgesia
- Being tested
- Epidural, Dural Puncture Epidural (DPE) technique, Combined Spinal-Epidural (CSE) technique
- Keywords
- epidural, cesarean, parturient
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiduralProcedure or surgery
Traditional epidural catheter placement
Dural Puncture Epidural (DPE) techniqueProcedure or surgery
Epidural catheters placed via DPE technique
Combined Spinal-Epidural (CSE) techniqueProcedure or surgery
Epidural catheters placed via CSE technique
| Study group | Role | What they receive |
|---|---|---|
| Dural puncture epidural (DPE) | Subjects that received neuraxial labor analgesia of dural puncture epidural for intrapartum cesarean delivery Receives: Procedure: Dural Puncture Epidural (DPE) technique | |
| Combined spinal epidural (CSE) | Subjects that received neuraxial labor analgesia of combined spinal epidural for intrapartum cesarean delivery Receives: Procedure: Combined Spinal-Epidural (CSE) technique | |
| Traditional Epidural | Subjects that received neuraxial labor analgesia of epidural for intrapartum cesarean delivery Receives: Procedure: Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to surgical anesthesia
Number of subject to have success of conversion to surgical anesthesia for intrapartum cesarean delivery
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Feb 2017
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Emily E. Sharpe, M.D., Mayo Clinic
- Investigators
- Emily Sharpe, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514431
- Sponsor's protocol ID
- 20-004677
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No