Recruiting

CompuFlo® CathCheck™

Sponsor:

Ohio State University

Code:

NCT07720908

Conditions

Anesthesia, Epidural

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CompuFlo® CathCheck™ System Assessment

Study Details

Brief summary:

This pilot study evaluates the use of the CompuFlo® CathCheck™ System to assess labor epidural catheter function before reactivation for postpartum tubal ligation. The study aims to determine whether this technology can accurately identify functional versus dysfunctional epidural catheters compared with standard clinical assessment methods. Improving catheter assessment may reduce failed epidural reactivation, the need for additional anesthesia techniques, and improve patient safety.

Conditions

Anesthesia, Epidural

Study ID

NCT07720908

Start date

Dec 19, 2024

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Age ≥ 18 years
  • Postpartum women electing to undergo tubal ligation with an indwelling labor epidural catheter
  • Ability to provide informed consent in English
  • Vaginal delivery

Exclusion Criteria

  • Parturients not receiving labor epidural analgesia or receiving an alternative anesthetic technique during labor and delivery
  • Epidural catheter located >2 cm from the documented insertion depth at initial placement
  • Planned elective cesarean delivery
  • Chronic pain conditions (e.g., chronic low back pain, sickle cell disease)
  • Chronic opioid use disorder
  • Chronic gabapentin use
  • Uncontrolled mood disorders that, in the investigator's judgment, may interfere with study participation or interpretation of study outcomes
  • Prisoners or incarcerated individuals

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Labor Epidural Reactivation Cohort

Postpartum women undergoing elective tubal ligation after vaginal delivery with an indwelling labor epidural catheter. Participants will undergo standard epidural catheter assessment and reactivation, including evaluation with the CompuFlo® CathCheck™ System to determine catheter functionality and predict successful epidural anesthesia for the tubal ligation procedure.

Interventions

CompuFlo® CathCheck™ System Assessment

Evaluation of labor epidural catheter functionality using the CompuFlo® CathCheck™ System following standard epidural test-dose administration and prior to epidural reactivation for postpartum tubal ligation.

Primary outcome measure

  • Rate of Successful Labor Epidural Catheter Reactivation [ Time Frame: Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure) ]

Central Contacts and Locations

Central contacts

Ling-Qun Hu, MD

6142933559LingQun.Hu@osumc.edu

Alberto Uribe Vega

6142933559alberto.uribe@osumc.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Ohio State University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Labor epidural catheter
  • Epidural catheter dysfunction
  • CompuFlo CathCheck System
  • Tubal ligation in parturients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-22.