Management of Indwelling Labor Epidural Catheters for Ces... | NCT07366307

Studies
Management of Indwelling Labor Epidural Catheters for Cesarean Delivery

NCT07366307

Sponsor

Baylor Research Institute

Status

Not yet recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Intraoperative Pain

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 2, 2026

First Submission Date that Met QC Criteria

Jan 16, 2026

First Posted Date

Jan 26, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2026

Last Update Posted Date

Jan 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective observational study that will survey patients who had an indwelling labor epidural catheter and subsequently underwent cesarean delivery. We hypothesize that patients who had removal of indwelling labor epidural catheters and had a new neuraxial anesthetic technique attempted will have a lower incidence of self-reported pain during cesarean delivery compared to patients who had top up of their indwelling labor epidural catheters.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Cesarean delivery patients		Patients who had an indwelling labor epidural catheter and subsequently underwent cesarean delivery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain during cesarean delivery	Patients will answer "yes" or "no" to whether they experienced pain during their cesarean delivery.	Patients will be asked this question once 24-72 hours after their cesarean delivery.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ages 18-50 years
had cesarean delivery at Baylor Scott & White Medical Center from January 1, 2026 through December 31, 2026
Fluent in the English language (our catastrophizing survey is validated in English language only)
Can provide their own consent
Identifies as Black or African American only, Hispanic, or White or Caucasian only
had administration of local anesthetic through indwelling labor epidural or removal of indwelling labor epidural followed by single injection spinal or combined spinal epidural

Exclusion Criteria:

less than 18 years old, older than 50 years old
had cesarean delivery at Baylor Scott & White Medical Center before January 1, 2026 or after December 31, 2026
Employee of Baylor Scott & White Health labor and delivery unit
Student of a school that performs clinical rotations at Baylor Scott & White Medical Center-Temple
Incarcerated at the time of study enrollment
Underwent scheduled cesarean hysterectomy
Underwent cesarean delivery with general anesthesia as either the primary anesthetic technique or had conversion to general anesthesia because of failure of neuraxial anesthesia
Admitted to the intensive care unit immediately following cesarean delivery
Did not have intrathecal morphine or intrathecal fentanyl if receiving spinal anesthesia
Had anesthesia for an attempted external cephalic version within 24 hours of cesarean delivery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Patients will be identified as potential study participants if they have a cesarean delivery at Baylor Scott & White Medical Center-Temple from January 1, 2026 through December 31, 2025.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Michael P Hofkamp, M.D.	Contact	254-724-3370		Michael.Hofkamp@bswhealth.org

Name	Affiliation	Role
Michael P Hofkamp, M.D.	Baylor Scott & White Medical Center-Temple	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39827661	Background	Litman J, Bates R, Lindheim SR, Sharpe EE, Ehrig JC, Hofkamp MP. Patient and clinical characteristics associated with pain during cesarean delivery: a prospective single-center patient-reported outcome study. Int J Obstet Anesth. 2025 Feb;61:104324. doi: 10.1016/j.ijoa.2024.104324. Epub 2025 Jan 10.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 16, 2025	Jan 16, 2026	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Dec 15, 2025	Jan 16, 2026	ICF_001.pdf

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms