Implementation of Calculated Cesarean Section Risk Study: Patient-focused Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Pennsylvania
- Enrollment
- 20,000
- Locations
- 14
- Primary Endpoint
- Cesarean delivery rate (for any indication)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Pre-utilization of cesarean risk calculator
The time prior to the implementation of the cesarean risk calculator at the labor and delivery unit.
Implementation of cesarean risk calculator
The cesarean risk calculator will be incorporated into routine care at the site
Intervention: Cesarean Risk Calculator (Other)
Outcomes
Primary Outcomes
Cesarean delivery rate (for any indication)
Time Frame: at time of delivery
Maternal morbidity
Time Frame: 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
Secondary Outcomes
- Neonatal morbidity(delivery admission)
Investigators
Rebecca Feldman Hamm
Assistant Professor
University of Pennsylvania