Cesarean DeliveryNCT06488092
IC-CS Risk: Patient Outcomes
A study testing Cesarean Risk Calculator in people with Cesarean Delivery, run by University of Pennsylvania at 14 sites in United States.
Trial summary
This study is looking at the impact of the implementation of a cesarean risk calculator on cesarean delivery and maternal morbidity rates. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- Cesarean Risk Calculator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Sep 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Postpartum patient who had a prior pregnancy resulting in Cesarean delivery
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Akron General
Akron, Ohio, 44307
University of Michigan
Ann Arbor, Michigan, 48109
Fairview Hospital
Cleveland, Ohio, 44111
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038
Henry Ford Hospital
Detroit, Michigan, 48202
Lancaster General Health
Lancaster, Pennsylvania, 17602
E.W. Sparrow Hospital
Lansing, Michigan, 48912
Logan Regional Hospital-Intermountain Healthcare
Logan, Utah, 84341
Hillcrest Hospital
Mayfield Heights, Ohio, 44124
McKay-Dee Hospital
Ogden, Utah, 84403
Princeton Medical Center
Plainsboro, New Jersey, 08536
Riverton Hospital-Intermountain Healthcare
Riverton, Utah, 84065
University of Utah Hospital
Salt Lake City, Utah, 84132
Chester County Hosptial
West Chester, Pennsylvania, 19380
About this study
Official title: Implementation of Calculated Cesarean Section Risk Study: Patient-focused Outcomes
This study is looking at the impact of the implementation of a cesarean risk calculator on cesarean delivery and maternal morbidity rates.
Read the 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.
- Conditions
- Cesarean Delivery
- Being tested
- Cesarean Risk Calculator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean Risk CalculatorOther
The cesarean risk calculator will be incorporated into routine care at the site
| Study group | Role | What they receive |
|---|---|---|
| Pre-utilization of cesarean risk calculator | No intervention | The time prior to the implementation of the cesarean risk calculator at the labor and delivery unit. |
| Implementation of cesarean risk calculator | Active comparator | The cesarean risk calculator will be incorporated into routine care at the site Receives: Other: Cesarean Risk Calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean delivery rate (for any indication)
Measured: 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
Measured: from delivery to 30 days postpartum
Secondary outcomes (1)
Neonatal morbidity
one or more of the following: severe respiratory distress, neonatal resuscitation outside of delivery room, and sepsis
Measured: delivery admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a quality improvement randomized roll-out pre-implementation and post-implementation study
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Rebecca Feldman Hamm, University of Pennsylvania
- Investigators
- Rebecca Hamm, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488092
- Sponsor's protocol ID
- 854955
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Calculated Cesarean Section Risk Study: Patient-focused Outcomes
- ClinicalTrials.gov ID
- NCT06488092
- Acronym / sponsor ID
- 854955
- Conditions
- Cesarean Delivery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quality improvement randomized roll-out pre-implementation and post-implementation study
| Arm | Type | Receives |
|---|---|---|
| Pre-utilization of cesarean risk calculator | No intervention | –The time prior to the implementation of the cesarean risk calculator at the labor and delivery unit. |
| Implementation of cesarean risk calculator | Active comparator | Other: Cesarean Risk CalculatorThe cesarean risk calculator will be incorporated into routine care at the site |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Postpartum patient who had a prior pregnancy resulting in Cesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesarean Risk CalculatorThe cesarean risk calculator will be incorporated into routine care at the site | Other | Implementation of cesarean risk calculator |
Primary outcome
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
1 secondary outcome
Neonatal morbidity
Time frame: delivery admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Hamm, MD principal investigator
University of Pennsylvania
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesarean Risk Calculator in people with Cesarean Delivery, run by University of Pennsylvania at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean delivery rate (for any indication) (time frame: at time of delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.