Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: DPE v CSE v Epidural

NCT ID: NCT05514431

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dural puncture epidural (DPE)

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

Dural Puncture Epidural (DPE) technique

Intervention Type PROCEDURE

Epidural catheters placed via DPE technique

Combined spinal epidural (CSE)

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

Combined Spinal-Epidural (CSE) technique

Intervention Type PROCEDURE

Epidural catheters placed via CSE technique

Traditional Epidural

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

Epidural

Intervention Type PROCEDURE

Traditional epidural catheter placement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Epidural

Traditional epidural catheter placement

Intervention Type PROCEDURE

Dural Puncture Epidural (DPE) technique

Epidural catheters placed via DPE technique

Intervention Type PROCEDURE

Combined Spinal-Epidural (CSE) technique

Epidural catheters placed via CSE technique

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. No local anesthetic given in epidural for cesarean delivery (in emergency situation)
2. Inadvertent dural puncture
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of British Columbia

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emily E. Sharpe, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emily Sharpe, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

BC Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-004677

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Epidural Analgesia on Electrophysiological Function
NCT02334150 COMPLETED PHASE2/PHASE3