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OpenTrials
Active, Not Recruiting

NCT Number: NCT06488092

IC-CS Risk: Patient Outcomes

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cesarean Delivery

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cesarean Risk Calculator

Other

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

Primary outcomes

  1. Cesarean delivery rate (for any indication)

    Time frame: at time of delivery

  2. 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

  1. Neonatal morbidity

    Time frame: delivery admission

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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