NCT07223775

Brief Summary

The study was done to learn how kangaroo care in the operating room help mothers and infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 3, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

2.4 years

First QC Date

October 10, 2025

Results QC Date

May 1, 2026

Last Update Submit

June 4, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    Delivery

  • Neonatal Morbidity

    Assess neonatal morbidity by collecting neonatal ICU (NICU) admissions rate from the patients' chart.

    Delivery

Study Arms (2)

Kangaroo Care

EXPERIMENTAL

This group received immediate post delivery via Cesarean section skin-to-skin interaction.

Procedure: Kangaroo Care

Standard OR care

NO INTERVENTION

This group received standard care post delivery via Cesarean section.

Interventions

Kangaroo CarePROCEDURE

Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.

Kangaroo Care

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy
  • Scheduled Cesarean Sections at KUMC
  • Term delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Meredith Gray, MD
Organization
The University of Kansas Medical Center

Study Officials

  • Meredith Gray, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2025

First Posted

November 3, 2025

Study Start

May 16, 2022

Primary Completion

October 24, 2024

Study Completion

October 24, 2024

Last Updated

June 8, 2026

Results First Posted

June 8, 2026

Record last verified: 2026-06

Locations