IC-CS Risk: Patient Outcomes

NCT06488092 | Active Not Recruiting

• 1 other identifier: 854955
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 14

Brief Summary

This study is looking at the impact of the implementation of a cesarean risk calculator on cesarean delivery and maternal morbidity rates.

Conditions

Cesarean Delivery

Outcome Measures

Primary Outcomes (2)

• Cesarean delivery rate (for any indication)

  at time of delivery

• Maternal morbidity

  one or more of the following: endometritis, postpartum hemorrhage greater than or equal to one liter, wound infection requiring antibiotics, venous thromboembolism, hysterectomy, intensive care unit admission, readmission within 30 days, and death

  from delivery to 30 days postpartum

Secondary Outcomes (1)

• Neonatal morbidity

  delivery admission

Study Arms (2)

Pre-utilization of cesarean risk calculator

NO INTERVENTION

The time prior to the implementation of the cesarean risk calculator at the labor and delivery unit.

Implementation of cesarean risk calculator

ACTIVE COMPARATOR

The cesarean risk calculator will be incorporated into routine care at the site

Other: Cesarean Risk Calculator

Interventions

Cesarean Risk Calculator OTHER

The cesarean risk calculator will be incorporated into routine care at the site

Implementation of cesarean risk calculator

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All postpartum patients who were eligible for cesarean risk calculator utilization:
• delivery of a full-term (greater than or equal to 37 weeks) singleton gestation after presenting
• with intact membranes
• undergoing an induction of labor from cervical dilation less than or equal to 2cm

You may not qualify if:

• Postpartum patient who had a prior pregnancy resulting in Cesarean delivery

Sponsors & Collaborators

• University of Pennsylvania: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (14)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Macomb Hospital

Clinton Township, Michigan, 48038, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

E.W. Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Princeton Medical Center

Plainsboro, New Jersey, 08536, United States

Location

Akron General

Akron, Ohio, 44307, United States

Location

Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

Location

Chester County Hosptial

West Chester, Pennsylvania, 19380, United States

Location

Logan Regional Hospital-Intermountain Healthcare

Logan, Utah, 84341, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Riverton Hospital-Intermountain Healthcare

Riverton, Utah, 84065, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Study Officials

• Rebecca Hamm, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a quality improvement randomized roll-out pre-implementation and post-implementation study

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 5, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

US (14)