IC-CS Risk: Patient Outcomes

N/AActive Not RecruitingNCT06488092

University of Pennsylvania20,000 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

20,000

Conditions

Cesarean Delivery

Interventions

Cesarean Risk CalculatorOTHER

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

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Cesarean delivery rate (for any indication)

Time frame: 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

Time frame: from delivery to 30 days postpartum

Secondary Outcomes

Neonatal morbidity

one or more of the following: severe respiratory distress, neonatal resuscitation outside of delivery room, and sepsis

Time frame: delivery admission

Data from ClinicalTrials.gov

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