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The study was done to learn how kangaroo care in the operating room help mothers and infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kangaroo Care | Experimental | This 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kangaroo Care | Procedure | Patients undergoing a planned cesarean section and assigned to the intervention group would get to hold their infant skin to skin immediately after delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meredith Gray, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard OR Care | This group received standard care post delivery via Cesarean section. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Delivery |
|
Delivery around 38 weeks gestation to discharge (24-72 hours postpartum).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Gray, MD | The University of Kansas Medical Center | 913-588-6200 | mgray6@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2023 | Jan 27, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2022 | Jan 27, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060127 | Kangaroo-Mother Care Method |
| ID | Term |
|---|---|
| D056888 | Patient Positioning |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D007224 | Infant Care |
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| Delivery |
| Neonatal Morbidity | Assess neonatal morbidity by collecting neonatal ICU (NICU) admissions rate from the patients' chart. | Delivery |
| Standard OR Care |
This group received standard care post delivery via Cesarean section. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nulliparous | Count of Participants | Participants |
|
| Repeat Cesarean-section | Count of Participants | Participants |
|
| Gestational age at delivery | Mean | Standard Deviation | weeks |
|
| OG001 |
| Standard OR Care |
This group received standard care post delivery via Cesarean section. |
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Delivery |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Number of additional medications | Delivery |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | mL | Delivery |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Delivery |
|
|
|
| Primary | Neonatal Morbidity | Assess neonatal morbidity by collecting neonatal ICU (NICU) admissions rate from the patients' chart. | Posted | Count of Participants | Participants | Delivery |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Standard OR Care | This group received standard care post delivery via Cesarean section. | 0 | 81 | 0 | 81 | 0 | 81 |
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| D002654 |
| Child Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |