IC-CS Risk: Patient Outcomes

Implementation of Calculated Cesarean Section Risk Study: Patient-focused Outcomes

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06488092

Enrollment

20000

Registered

2024-07-05

Start date

2024-09-01

Completion date

2027-09-30

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery

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.

Interventions

OTHERCesarean Risk Calculator

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
Cesarean delivery rate (for any indication)	at time of delivery	—
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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026