Clinical trial NCT06488092: IC-CS Risk: Patient Outcomes
Official title: Implementation of Calculated Cesarean Section Risk Study: Patient-focused Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cesarean Delivery
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Developement
First posted: 2024-07-05
Enrollment: 20000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See eligibility criteria above.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cesarean delivery rate (for any indication)
timeFrame: at time of delivery
measure: Maternal morbidity
timeFrame: from delivery to 30 days postpartum
Secondary outcomes:
measure: Neonatal morbidity
timeFrame: delivery admission
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Clinton Township
country: United States
facility: Henry Ford Macomb Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lansing
country: United States
facility: E.W. Sparrow Hospital
state: Michigan
city: Plainsboro
country: United States
facility: Princeton Medical Center
state: New Jersey
city: Akron
country: United States
facility: Akron General
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hosptial
state: Pennsylvania
city: Logan
country: United States
facility: Logan Regional Hospital-Intermountain Healthcare
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Riverton
country: United States
facility: Riverton Hospital-Intermountain Healthcare
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: University of Pennsylvania
name: Rebecca Hamm, MD
role: PRINCIPAL_INVESTIGATOR
References: