IC-CS Risk: Patient Outcomes

NCT ID: NCT06488092

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cesarean Delivery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This is a quality improvement randomized roll-out pre-implementation and post-implementation study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pre-utilization of cesarean risk calculator

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Implementation of cesarean risk calculator

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

Group Type ACTIVE_COMPARATOR

Cesarean Risk Calculator

Intervention Type OTHER

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

Interventions

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Cesarean Risk Calculator

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Feldman Hamm

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Hamm, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Henry Ford Macomb Hospital

Clinton Township, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

E.W. Sparrow Hospital

Lansing, Michigan, United States

Site Status

Princeton Medical Center

Plainsboro, New Jersey, United States

Site Status

Akron General

Akron, Ohio, United States

Site Status

Fairview Hospital

Cleveland, Ohio, United States

Site Status

Hillcrest Hospital

Mayfield Heights, Ohio, United States

Site Status

Lancaster General Health

Lancaster, Pennsylvania, United States

Site Status

Chester County Hosptial

West Chester, Pennsylvania, United States

Site Status

Logan Regional Hospital-Intermountain Healthcare

Logan, Utah, United States

Site Status

McKay-Dee Hospital

Ogden, Utah, United States

Site Status

Riverton Hospital-Intermountain Healthcare

Riverton, Utah, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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854955

Identifier Type: -

Identifier Source: org_study_id

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