Cesarean SectionNCT07223775
Kangaroo Care in the Operating Room
A study testing Kangaroo Care in people with Cesarean Section and Skin to Skin, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The study was done to learn how kangaroo care in the operating room help mothers and infants. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Skin to Skin, Kangaroo Care
- What is being tested?
- Kangaroo Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 24 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy
- Scheduled Cesarean Sections at KUMC
- Term delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The study was done to learn how kangaroo care in the operating room help mothers and infants.
- Conditions
- Cesarean Section, Skin to Skin, Kangaroo Care
- Being tested
- Kangaroo Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareProcedure or surgery
Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Care | Experimental | This group received immediate post delivery via Cesarean section skin-to-skin interaction. Receives: Procedure: Kangaroo Care |
| Standard OR care | No intervention | This group received standard care post delivery via Cesarean section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal C-section Satisfaction
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.
Measured: Delivery
Maternal Pain Level
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.
Measured: Delivery
Maternal Pain Medication Need
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.
Measured: Delivery
Cesarean Section Blood Loss
Assess quantitative blood loss (QBL) of the cesarean section by collecting QBL in milliliters (mL) from the patients' chart delivery note.
Measured: Delivery
Neonatal Morbidity APGAR Test
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.
Measured: Delivery
Neonatal Morbidity
Assess neonatal morbidity by collecting neonatal ICU (NICU) admissions rate from the patients' chart.
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start16 May 2022
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meredith Gray, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223775
- Sponsor's protocol ID
- STUDY00148361
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2025
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kangaroo Care in the Operating Room
- ClinicalTrials.gov ID
- NCT07223775
- Acronym / sponsor ID
- STUDY00148361
- Conditions
- Cesarean Section, Skin to Skin, Kangaroo Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 3 Nov 2025 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was done to learn how kangaroo care in the operating room help mothers and infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Care | Experimental | Procedure: Kangaroo CareThis group received immediate post delivery via Cesarean section skin-to-skin interaction. |
| Standard OR care | No intervention | –This group received standard care post delivery via Cesarean section. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Scheduled Cesarean Sections at KUMC
- Term delivery
Key exclusion criteria (8 listed)
- Priority, urgent and emergent Cesarean sections
- Planned general anesthesia
- Fetal anomalies
- Fetal aneuploidy/genetic syndrome
- Abnormal fetal dopplers
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 |
|---|---|---|
| Kangaroo CarePatients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery. | Procedure or surgery | Kangaroo Care |
Primary outcome
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.
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.
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.
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.
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.
Neonatal Morbidity
Time frame: Delivery
Assess neonatal morbidity by collecting neonatal ICU (NICU) admissions rate from the patients' chart.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cesarean Section
Not yet recruitingObservational study
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Cesarean Section (MeSH: D002585), Anesthesia
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Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
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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.
Meredith Gray, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Care in people with Cesarean Section and Skin to Skin, run by University of Kansas Medical Center at 1 site 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maternal C-section Satisfaction (time frame: Delivery). The study lists 6 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 8 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.