IC-CS Risk: Patient Outcomes

Implementation of Calculated Cesarean Section Risk Study: Patient-focused Outcomes

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cesarean Delivery
• Intervention / Treatment: Other: Cesarean Risk Calculator

Detailed Description

In this study a cesarean risk calculator will be instituted as a part of standard of care in a randomized rollout at 14 labor and delivery clinical sites across 4 institutions. The leadership at all of the sites have planned to implement this intervention for routine use at both sites. This study will evaluate cesarean delivery rates and maternal morbidity before and after implementation at each site.

• Study Type: Interventional
• Enrollment (Estimated): 20000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Clinton Township, Michigan, United States, 48038
      • Henry Ford Macomb Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Lansing, Michigan, United States, 48912
      • E.W. Sparrow Hospital
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Princeton Medical Center
  • Ohio
    • Akron, Ohio, United States, 44307
      • Akron General
    • Cleveland, Ohio, United States, 44111
      • Fairview Hospital
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Health
    • West Chester, Pennsylvania, United States, 19380
      • Chester County Hosptial
  • Utah
    • Logan, Utah, United States, 84341
      • Logan Regional Hospital-Intermountain Healthcare
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital
    • Riverton, Utah, United States, 84065
      • Riverton Hospital-Intermountain Healthcare
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

See eligibility criteria above.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Postpartum patient who had a prior pregnancy resulting in Cesarean delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-utilization of cesarean risk calculator; The time prior to the implementation of the cesarean risk calculator at the labor and delivery unit.
Active Comparator: Implementation of cesarean risk calculator; The cesarean risk calculator will be incorporated into routine care at the site	Other: Cesarean Risk Calculator; The cesarean risk calculator will be incorporated into routine care at the site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal morbidity	one or more of the following: severe respiratory distress, neonatal resuscitation outside of delivery room, and sepsis	delivery admission

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Rebecca Hamm, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 854955

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No