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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: Dural Puncture Epidural vs Combined Spinal Epidural vs Epidural
- ClinicalTrials.gov ID
- NCT05514431
- Acronym / sponsor ID
- 20-004677
- Conditions
- Anesthesia, Analgesia
- Keywords
- epidural, cesarean, parturient
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Aug 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dural puncture epidural (DPE) | – | Procedure: Dural Puncture Epidural (DPE) techniqueSubjects that received neuraxial labor analgesia of dural puncture epidural for intrapartum cesarean delivery |
| Combined spinal epidural (CSE) | – | Procedure: Combined Spinal-Epidural (CSE) techniqueSubjects that received neuraxial labor analgesia of combined spinal epidural for intrapartum cesarean delivery |
| Traditional Epidural | – | Procedure: EpiduralSubjects that received neuraxial labor analgesia of epidural for intrapartum cesarean delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parturients that undergo intrapartum cesarean delivery with an epidural already in situ.
Key inclusion criteria (2 listed)
- Women with neuraxial labor analgesia (CSE, DPE, or Epidural) who have an intrapartum cesarean delivery
- Singleton gestation
Key exclusion criteria (2 listed)
- No local anesthetic given in epidural for cesarean delivery (in emergency situation)
- Inadvertent dural puncture
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 |
|---|---|---|
| EpiduralTraditional epidural catheter placement | Procedure or surgery | Traditional Epidural |
| Dural Puncture Epidural (DPE) techniqueEpidural catheters placed via DPE technique | Procedure or surgery | Dural puncture epidural (DPE) |
| Combined Spinal-Epidural (CSE) techniqueEpidural catheters placed via CSE technique | Procedure or surgery | Combined spinal epidural (CSE) |
Primary outcome
Conversion to surgical anesthesia
Time frame: Baseline
Number of subject to have success of conversion to surgical anesthesia for intrapartum cesarean delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Emily Sharpe, MD principal investigator
Mayo Clinic
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Analgesia, run by Mayo Clinic at 2 sites in 2 countries.
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Conversion to surgical anesthesia (time frame: Baseline). 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 2 Sep 2026.