- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07223775
Kangaroo Care in the Operating Room
June 4, 2026 updated by: University of Kansas Medical Center
The study was done to learn how kangaroo care in the operating room help mothers and infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
158
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 Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- The University of Kansas Medical Center
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Singleton pregnancy
- Scheduled Cesarean Sections at KUMC
- Term delivery
Exclusion Criteria:
- Priority, urgent and emergent Cesarean sections
- Planned general anesthesia
- Fetal anomalies
- Fetal aneuploidy/genetic syndrome
- Abnormal fetal dopplers
- Placental previa/accreta
- Multiple gestations
- Preeclampsia with severe features
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kangaroo Care
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
|
Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
|
No Intervention: Standard OR care
This group received standard care post delivery via Cesarean section.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal C-section Satisfaction
Time Frame: Delivery
|
Assess maternal Cesarean section (C-section) satisfaction using Likert-scale surveys.
Survey scale was one to five, a higher score is better as it indicates the participants were satisfied/content about the procedure; response legend is the following: 1 = Very Unsatisfied, 2 = Unsatisfied, 3 = neutral, 4 Satisfied, and 5 = Very Satisfied.
Maximum potential score for the survey is 5 and 1 is the minimum score.
Reporting Likert's median score per participants' scores at delivery.
|
Delivery
|
|
Maternal Pain Level
Time Frame: Delivery
|
Assess maternal pain using Likert-scale surveys.
Survey scale was one to five, a lower score is better as it indicates the participant experienced no pain to mild, annoying pain; responses legend is the following: 1 = No pain, 2 = Mild, annoying pain, 3 = Nagging pain, 4 = intense pain, and 5 = Unbearable pain.
Maximum potential score for the survey is 5 and 1 is the minimum score.
Reporting Likert's median score per participants' scores at delivery.
|
Delivery
|
|
Maternal Pain Medication Need
Time Frame: Delivery
|
Assess maternal need for additional pain medication for their cesarean section delivery by collecting pain medication provided during their labor and delivery from the patients' chart.
|
Delivery
|
|
Cesarean Section Blood Loss
Time Frame: Delivery
|
Assess quantitative blood loss (QBL) of the cesarean section by collecting QBL in milliliters (mL) from the patients' chart delivery note.
|
Delivery
|
|
Neonatal Morbidity APGAR Test
Time Frame: Delivery
|
Assess neonatal morbidity by collecting neonatal 5-minute Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) test scores from the patients' chart.
Each of the five criteria can be scored 0-2 with a possible total test score ranging from 0-10 with three subcategories; reassuring: score 7-10, moderately abnormal: 4-6 and low: 0-3.
A higher score indicates better neonatal outcomes.
|
Delivery
|
|
Neonatal Morbidity
Time Frame: Delivery
|
Assess neonatal morbidity by collecting neonatal ICU (NICU) admissions rate from the patients' chart.
|
Delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Meredith Gray, MD, University of Kansas Medical Center
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 (Actual)
May 16, 2022
Primary Completion (Actual)
October 24, 2024
Study Completion (Actual)
October 24, 2024
Study Registration Dates
First Submitted
October 10, 2025
First Submitted That Met QC Criteria
October 29, 2025
First Posted (Actual)
November 3, 2025
Study Record Updates
Last Update Posted (Actual)
June 8, 2026
Last Update Submitted That Met QC Criteria
June 4, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00148361
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.
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