Trial Outcomes & Findings for Kangaroo Care in the Operating Room (NCT NCT07223775)
NCT ID: NCT07223775
Last Updated: 2026-06-08
Results Overview
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.
COMPLETED
NA
158 participants
Delivery
2026-06-08
Participant Flow
Participant milestones
| Measure |
Kangaroo Care
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
Kangaroo Care: Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
Standard OR Care
This group received standard care post delivery via Cesarean section.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
81
|
|
Overall Study
COMPLETED
|
77
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Kangaroo Care in the Operating Room
Baseline characteristics by cohort
| Measure |
Kangaroo Care
n=77 Participants
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
Kangaroo Care: Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
Standard OR Care
n=81 Participants
This group received standard care post delivery via Cesarean section.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=9 Participants
|
81 Participants
n=27 Participants
|
158 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 5.28 • n=9 Participants
|
32.1 years
STANDARD_DEVIATION 5.53 • n=27 Participants
|
31.7 years
STANDARD_DEVIATION 5.41 • n=267 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=9 Participants
|
81 Participants
n=27 Participants
|
158 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
38 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
68 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Black, Non-Hispanic
|
12 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
23 Participants
n=9 Participants
|
32 Participants
n=27 Participants
|
55 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=9 Participants
|
81 participants
n=27 Participants
|
158 participants
n=267 Participants
|
|
Nulliparous
|
14 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
26 Participants
n=267 Participants
|
|
Repeat Cesarean-section
|
51 Participants
n=9 Participants
|
57 Participants
n=27 Participants
|
108 Participants
n=267 Participants
|
|
Gestational age at delivery
|
38.1 weeks
STANDARD_DEVIATION 0.98 • n=9 Participants
|
38.8 weeks
STANDARD_DEVIATION 0.91 • n=27 Participants
|
38.2 weeks
STANDARD_DEVIATION 0.95 • n=267 Participants
|
PRIMARY outcome
Timeframe: DeliveryAssess 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.
Outcome measures
| Measure |
Standard OR Care
n=81 Participants
This group received standard care post delivery via Cesarean section.
|
Kangaroo Care
n=77 Participants
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
Kangaroo Care: Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
|---|---|---|
|
Maternal C-section Satisfaction
|
5 score on a scale
Interval 4.0 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
PRIMARY outcome
Timeframe: DeliveryAssess 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.
Outcome measures
| Measure |
Standard OR Care
n=81 Participants
This group received standard care post delivery via Cesarean section.
|
Kangaroo Care
n=77 Participants
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
Kangaroo Care: Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
|---|---|---|
|
Maternal Pain Level
|
1 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: DeliveryAssess 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.
Outcome measures
| Measure |
Standard OR Care
n=81 Participants
This group received standard care post delivery via Cesarean section.
|
Kangaroo Care
n=77 Participants
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
Kangaroo Care: Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
|---|---|---|
|
Maternal Pain Medication Need
|
1.5 Number of additional medications
Standard Deviation 0.9
|
1.9 Number of additional medications
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: DeliveryAssess quantitative blood loss (QBL) of the cesarean section by collecting QBL in milliliters (mL) from the patients' chart delivery note.
Outcome measures
| Measure |
Standard OR Care
n=81 Participants
This group received standard care post delivery via Cesarean section.
|
Kangaroo Care
n=77 Participants
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
Kangaroo Care: Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
|---|---|---|
|
Cesarean Section Blood Loss
|
700 mL
Interval 500.0 to 974.0
|
695 mL
Interval 462.0 to 800.0
|
PRIMARY outcome
Timeframe: DeliveryAssess 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.
Outcome measures
| Measure |
Standard OR Care
n=81 Participants
This group received standard care post delivery via Cesarean section.
|
Kangaroo Care
n=77 Participants
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
Kangaroo Care: Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
|---|---|---|
|
Neonatal Morbidity APGAR Test
|
9 score on a scale
Interval 8.0 to 9.0
|
9 score on a scale
Interval 8.0 to 9.0
|
PRIMARY outcome
Timeframe: DeliveryAssess neonatal morbidity by collecting neonatal ICU (NICU) admissions rate from the patients' chart.
Outcome measures
| Measure |
Standard OR Care
n=81 Participants
This group received standard care post delivery via Cesarean section.
|
Kangaroo Care
n=77 Participants
This group received immediate post delivery via Cesarean section skin-to-skin interaction.
Kangaroo Care: Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery.
|
|---|---|---|
|
Neonatal Morbidity
|
10 Participants
|
7 Participants
|
Adverse Events
Kangaroo Care
Standard OR Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Meredith Gray, MD
The University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place