IC-CS Risk: Patient Outcomes

Active, not recruiting

• Conditions: Cesarean Delivery

• Registration Number: NCT06488092
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-05
• Study Start: 2024-09-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal morbidity	from delivery to 30 days postpartum	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
Cesarean delivery rate (for any indication)	at time of delivery

Secondary Outcome Measures

Name	Time	Method
Neonatal morbidity	delivery admission	one or more of the following: severe respiratory distress, neonatal resuscitation outside of delivery room, and sepsis

Trial Locations

Locations (14)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Macomb Hospital; 🇺🇸 Clinton Township, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

E.W. Sparrow Hospital; 🇺🇸 Lansing, Michigan, United States

Princeton Medical Center; 🇺🇸 Plainsboro, New Jersey, United States

Akron General; 🇺🇸 Akron, Ohio, United States

Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States

Hillcrest Hospital; 🇺🇸 Mayfield Heights, Ohio, United States

Lancaster General Health; 🇺🇸 Lancaster, Pennsylvania, United States

Chester County Hosptial; 🇺🇸 West Chester, Pennsylvania, United States

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