NCT05514431

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Feb 2017Jul 2026

Study Start

First participant enrolled

February 1, 2017

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

9.4 years

First QC Date

August 22, 2022

Last Update Submit

August 13, 2025

Conditions

Keywords

epiduralcesareanparturient

Outcome Measures

Primary Outcomes (1)

  • Conversion to surgical anesthesia

    Number of subject to have success of conversion to surgical anesthesia for intrapartum cesarean delivery

    Baseline

Study Arms (3)

Dural puncture epidural (DPE)

Subjects that received neuraxial labor analgesia of dural puncture epidural for intrapartum cesarean delivery

Procedure: Dural Puncture Epidural (DPE) technique

Combined spinal epidural (CSE)

Subjects that received neuraxial labor analgesia of combined spinal epidural for intrapartum cesarean delivery

Procedure: Combined Spinal-Epidural (CSE) technique

Traditional Epidural

Subjects that received neuraxial labor analgesia of epidural for intrapartum cesarean delivery

Procedure: Epidural

Interventions

EpiduralPROCEDURE

Traditional epidural catheter placement

Traditional Epidural

Epidural catheters placed via DPE technique

Dural puncture epidural (DPE)

Epidural catheters placed via CSE technique

Combined spinal epidural (CSE)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parturients that undergo intrapartum cesarean delivery with an epidural already in situ.

You may qualify if:

  • Women with neuraxial labor analgesia (CSE, DPE, or Epidural) who have an intrapartum cesarean delivery
  • Singleton gestation

You may not qualify if:

  • No local anesthetic given in epidural for cesarean delivery (in emergency situation)
  • Inadvertent dural puncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

BC Women's Hospital

Vancouver, British Columbia, Canada

Location

Related Links

MeSH Terms

Conditions

Agnosia

Interventions

Injections, EpiduralMethods

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeuticsInvestigative Techniques

Study Officials

  • Emily Sharpe, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

February 1, 2017

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations