- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07756424
Implementation of a Disparities in Labor Outcomes Dashboard
August 6, 2026 updated by: University of Pennsylvania
This proposal will determine if a Disparities in Labor Outcomes dashboard can be used as an implementation strategy to increase compliance to an evidence-based set of interventions for labor induction in a two-site difference-in-differences study design.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
2300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rebecca Hamm, MD MSCE
- Phone Number: 2156626400
- Email: rebecca.feldmanhamm@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Hospital of the University of Pennsylvania; Pennsylvania Hospital
-
Contact:
- Rebecca Hamm
- Phone Number: 215-662-6400
- Email: rebecca.feldmanhamm@pennmedicine.upenn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- full term (greater than or equal to 37 weeks gestation)
- singleton gestations
- intact membranes
- undergoing an induction of labor requiring cervical ripening
Exclusion criteria:
- prior cesarean
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre period
|
|
|
Other: Post period
|
This Dashboard, a method of audit and feedback, will detail use of evidence-based practices and clinical outcomes on labor and delivery as attributed to individual clinicians on labor and delivery, stratified by race and ethnicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fidelity to a labor induction protocol recommendation to perform all cervical exams performed in latent labor were performed less than or equal to 4.5 hours apart
Time Frame: from first cervical exam after admission for labor induction until the patient's cervical exam reaches 6cm dilation
|
Reported as binary - compliant or noncompliant; Time between cervical exams from first exam at admission for labor induction to reaching 6cm dilation will be calculated.
If any time between exams is >=4.5 hours, the outcome will be considered "non-compliant".
If all are <4.5 hours, the outcome will be "compliant."
|
from first cervical exam after admission for labor induction until the patient's cervical exam reaches 6cm dilation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cesarean delivery
Time Frame: single time point, at the time of delivery
|
Reported as binary (yes cesarean or no cesarean); mode of delivery (cesarean or vaginal) will be determined at the time of delivery
|
single time point, at the time of delivery
|
|
Maternal morbidity
Time Frame: from delivery until 30 days postpartum
|
greater than or equal to 1 of the following: endometritis, postpartum hemorrhage, blood transfusion, wound infection, venous thromboembolism, hysterectomy, intensive care unit admission, readmission within 30 days, and death
|
from delivery until 30 days postpartum
|
|
Time to delivery
Time Frame: as time from start of induction to delivery in hours
|
as time from start of induction to delivery in hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
July 21, 2026
First Submitted That Met QC Criteria
August 6, 2026
First Posted (Actual)
August 10, 2026
Study Record Updates
Last Update Posted (Actual)
August 10, 2026
Last Update Submitted That Met QC Criteria
August 6, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 858750
- R21HD114902-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.