Earlier Family Bond Initiation, Maternal and Neonatal Outcomes, Patient Satisfaction
Conditions
Keywords
Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes
Brief summary
The purpose of this study is to determine if patient birthing experiences differ between the family-centered and traditional cesarean methods. We hypothesize that the family-centered cesarean method will lead to more unique and personalized cesarean birthing experiences without increasing the risks of adverse neonatal and maternal outcomes from those documented with the traditional cesarean.
Detailed description
Patients will be consented and randomized to one of two delivery methods by the research coordinator, resident physician, charge nurse or nurse on the day of their planned cesarean section. Several variables of interest will be collected via the electronic medical record and within the OR. Additionally, assessment of patient satisfaction will be conducted following delivery. Questions from an 11-item questionnaire will be asked of the patient by the study coordinator, resident physician, nurse or charge nurses.
Interventions
PROCEDURETraditional Cesarean
Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request.
PROCEDUREFamily-Centered Cesarean
Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women ≥18 years of age * Women with planned cesarean section * ≥38 weeks of gestation * Singleton fetus * Reassuring fetal status (status of scheduled, green and some yellow
Exclusion criteria
* Women with an urgent or emergency clinical situation in which the medical staff caring for the patient determines that obtaining consent would interfere with the patient's clinical care * Patients that decline to consent to participate (an opt out log including the consenters initials, time of day, and reason is kept) * Patients with anticipated heavy intraoperative bleeding (bleeding disorders, placenta previa, suspected placenta abruption, etc.) * Known maternal co-morbidities that could impact neonatal well-being (e.g., uncontrolled diabetes, etc.) * Chorioamnionitis or prolonged rupture of membranes (≥18 hours in duration) * Known fetal anomalies * BMI ≥45 kg/m2 * Estimated fetal weight \<2000 grams
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 11-item Patient Satisfaction Questionnaire | Assessed at time of discharge from the hospital (typically 3-5 days post-delivery) | The primary objective of this study was to compare satisfaction with birthing experiences between women who underwent either a family-centered or traditional cesarean delivery, using a modified Likert scale, ranging from 1 (lowest) to 5 (highest). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timing of Initiation of Family Bond Following Delivery | Assessed in Operating Room | The secondary objective of this study is to determine if there is a difference in time-to-initiation of family bond between the family-centered cesarean delivery method and traditional cesarean delivery method. |
| Number (Percent) of Patients Planning to Breastfeeding After Discharge | Assessed at time of discharge from the hospital (typically 3-5 days post-delivery) | The tertiary objective of this study is to determine if breastfeeding was more likely to occur between the family-centered cesarean delivery method and traditional cesarean delivery method. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Method 1 (Family Centered Cesarean) Delivery through the Family-Centered Cesarean.
Family-Centered Cesarean: Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed. | 68 |
| Method 2 (Traditional Cesarean) Delivery through the Traditional Cesarean.
Traditional Cesarean: Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request. | 61 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded by IRB | 0 | 2 |
| Overall Study | Excluded from analyses for no OR worksheet or questionnaire completed | 5 | 8 |
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Method 1 (Family Centered Cesarean) | Method 2 (Traditional Cesarean) | Total |
|---|---|---|---|
| Age, Continuous | 28.9 years STANDARD_DEVIATION 5.6 | 29.5 years STANDARD_DEVIATION 5.2 | 29.2 years STANDARD_DEVIATION 5.4 |
| Race/Ethnicity, Customized Black non-Hispanic | 27 Participants | 24 Participants | 51 Participants |
| Race/Ethnicity, Customized Hispanic | 12 Participants | 15 Participants | 27 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 26 Participants | 20 Participants | 46 Participants |
| Sex: Female, Male Female | 68 Participants | 61 Participants | 129 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 76 |
| other Total, other adverse events | 0 / 73 | 0 / 76 |
| serious Total, serious adverse events | 0 / 73 | 0 / 76 |
Outcome results
Primary
11-item Patient Satisfaction Questionnaire
The primary objective of this study was to compare satisfaction with birthing experiences between women who underwent either a family-centered or traditional cesarean delivery, using a modified Likert scale, ranging from 1 (lowest) to 5 (highest).
Time frame: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Method 1 (Family-Centered Cesarean) | 11-item Patient Satisfaction Questionnaire | How satisfied were you with your involvement with the delivery of the baby? | 4.6 units on a scale | Standard Deviation 0.8 |
| Method 1 (Family-Centered Cesarean) | 11-item Patient Satisfaction Questionnaire | Did the method for delivery meet your expectations? | 4.6 units on a scale | Standard Deviation 0.7 |
| Method 1 (Family-Centered Cesarean) | 11-item Patient Satisfaction Questionnaire | Based on previous cesarean delivery how satisfied are you with the method of delivery of your baby? | 4.9 units on a scale | Standard Deviation 0.7 |
| Method 2 (Traditional Cesarean) | 11-item Patient Satisfaction Questionnaire | How satisfied were you with your involvement with the delivery of the baby? | 4.4 units on a scale | Standard Deviation 0.9 |
| Method 2 (Traditional Cesarean) | 11-item Patient Satisfaction Questionnaire | Did the method for delivery meet your expectations? | 4.3 units on a scale | Standard Deviation 1 |
| Method 2 (Traditional Cesarean) | 11-item Patient Satisfaction Questionnaire | Based on previous cesarean delivery how satisfied are you with the method of delivery of your baby? | 4.7 units on a scale | Standard Deviation 1 |
Secondary
Number (Percent) of Patients Planning to Breastfeeding After Discharge
The tertiary objective of this study is to determine if breastfeeding was more likely to occur between the family-centered cesarean delivery method and traditional cesarean delivery method.
Time frame: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Method 1 (Family-Centered Cesarean) | Number (Percent) of Patients Planning to Breastfeeding After Discharge | 47 Participants |
| Method 2 (Traditional Cesarean) | Number (Percent) of Patients Planning to Breastfeeding After Discharge | 33 Participants |
Secondary
Timing of Initiation of Family Bond Following Delivery
The secondary objective of this study is to determine if there is a difference in time-to-initiation of family bond between the family-centered cesarean delivery method and traditional cesarean delivery method.
Time frame: Assessed in Operating Room
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Method 1 (Family-Centered Cesarean) | Timing of Initiation of Family Bond Following Delivery | 5.1 minutes | Standard Deviation 17.2 |
| Method 2 (Traditional Cesarean) | Timing of Initiation of Family Bond Following Delivery | 16.3 minutes | Standard Deviation 13.9 |