Cesarean Section, Kangaroo Care, Skin to Skin
Conditions
Brief summary
The study was done to learn how kangaroo care in the operating room help mothers and infants.
Interventions
PROCEDUREKangaroo 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.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 47 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal C-section Satisfaction | 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 | 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 | 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 | 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 | 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 | Delivery | Assess neonatal morbidity by collecting neonatal ICU (NICU) admissions rate from the patients' chart. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMeredith Gray, MD
University of Kansas Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 158 Participants |
| Age, Continuous | 31.7 years STANDARD_DEVIATION 5.41 |
| Gestational age at delivery | 38.1 weeks STANDARD_DEVIATION 0.98 |
| Nulliparous | 14 Participants |
| Race/Ethnicity, Customized Black, Non-Hispanic | 12 Participants |
| Race/Ethnicity, Customized Hispanic | 32 Participants |
| Race/Ethnicity, Customized Other | 12 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 38 Participants |
| Region of Enrollment United States | 158 participants |
| Repeat Cesarean-section | 51 Participants |
| Sex: Female, Male Female | 158 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 81 |
| other Total, other adverse events | 0 / 77 | 0 / 81 |
| serious Total, serious adverse events | 0 / 77 | 0 / 81 |
Outcome results
None listed