Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06284421

Conditions

Uterine Tone Disorders

Cesarean Section Complications

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Shore durometer

Study Details

Brief summary:

This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery.

Conditions

Uterine Tone Disorders

Cesarean Section Complications

Study ID

NCT06284421

Start date

Feb 8, 2024

Status verified date

May, 2025

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Mar 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Non-emergent (scheduled) cesarean delivery at University of Chicago Family Birth Center
  • Patients ages 18-50

Exclusion Criteria:

  • Patients undergoing unscheduled (intrapartum) cesarean delivery
  • Ages <18 or >50 years old
  • Intrapartum cesarean hysterectomy
  • Inability to provide independent, informed consent due to impairment or intellectual disability
  • Non-English speaking patients

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Durometer

This is a single-arm trial in which a Shore durometer will be used to measure the hardness of the uterus after placental delivery during cesarean section.

Interventions

Shore durometer

The durometer will be held on the exterior of the lower uterine segment and fundus to measure the hardness reading at each location.

Primary outcome measure

  • feasibility of a durometer [ Time Frame: within 10 minutes after placental delivery ]

Central Contacts and Locations

Central contacts

Al McAuley

(773) 834-3274amcauley1@dacc.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Naida M Cole, MD

773-702-6700nmcole@bsd.uchicago.edu

Somayeh Mohammadi

17738343274mohammadis@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

May 6, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-05-06.