An interventional study of Family-Centered Cesarean and Traditional Cesarean in Patient Satisfaction, Earlier Family Bond Initiation and Maternal and Neonatal Outcomes, sponsored by Wake Forest University Health Sciences. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research
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.
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.
278 studies on the registry are indexed under Patient Satisfaction; 130 are open to participants now.
This study's enrollment of 149 is above the median of 93 across 212 interventional studies indexed under Patient Satisfaction.
Browse Patient Satisfaction studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
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Exclusion Criteria:
Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference.
Procedure: Family-Centered Cesarean
Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference.
Procedure: Family-Centered Cesarean
Delivery through the Traditional Cesarean for patients with known Family-Centered preference.
Procedure: Traditional Cesarean
Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference.
Procedure: Traditional 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.
Also known as: Gentle 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.
Also known as: Cesarean Section
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)
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
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)
| Milestone | Method 1 (Family-Centered Cesarean) | Method 2 (Traditional Cesarean) |
|---|---|---|
| Started | 73 | 76 |
| Completed | 68 | 61 |
| Not completed | 5 | 15 |
| Withdrew: Excluded from analyses for no or worksheet or questionnaire completed | 5 | 8 |
| Withdrew: Withdrawal by subject | 0 | 5 |
| Withdrew: Excluded by irb | 0 | 2 |
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).
| units on a scale | Method 1 (Family-Centered Cesarean) | Method 2 (Traditional Cesarean) |
|---|---|---|
| How satisfied were you with your involvement with the delivery of the baby? | 4.6 ± 0.8 | 4.4 ± 0.9 |
| Did the method for delivery meet your expectations? | 4.6 ± 0.7 | 4.3 ± 1.0 |
| Based on previous cesarean delivery how satisfied are you with the method of delivery of your baby? | 4.9 ± 0.7 | 4.7 ± 1.0 |
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.
| minutes | Method 1 (Family-Centered Cesarean) | Method 2 (Traditional Cesarean) |
|---|---|---|
| Timing of Initiation of Family Bond Following Delivery | 5.1 ± 17.2 | 16.3 ± 13.9 |
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.
| Participants | Method 1 (Family-Centered Cesarean) | Method 2 (Traditional Cesarean) |
|---|---|---|
| Number (Percent) of Patients Planning to Breastfeeding After Discharge | 47 | 33 |
Collected over 2 years, 1 month (participants were followed through discharge).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Method 1 (Family Centered Cesarean) | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
| Method 2 (Traditional Cesarean) | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Age, Continuous(years) | Method 1 (Family Centered Cesarean) | Method 2 (Traditional Cesarean) | Total |
|---|---|---|---|
| Mean | 28.9 ± 5.6 | 29.5 ± 5.2 | 29.2 ± 5.4 |
| Sex: Female, Male(Participants) | Method 1 (Family Centered Cesarean) | Method 2 (Traditional Cesarean) | Total |
|---|---|---|---|
| Female | 68 | 61 | 129 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Method 1 (Family Centered Cesarean) | Method 2 (Traditional Cesarean) | Total |
|---|---|---|---|
| White non-Hispanic | 26 | 20 | 46 |
| Black non-Hispanic | 27 | 24 | 51 |
| Hispanic | 12 | 15 | 27 |
| Other | 3 | 2 | 5 |
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