N/A
N=149
Family-Centered Cesarean Delivery
Patient Satisfaction · Earlier Family Bond Initiation · Maternal and Neonatal Outcomes
Bottom Line
View on ClinicalTrials.gov: NCT02690077 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: 11-item Patient Satisfaction Questionnaire — 4.6; 4.4; 4.6; 4.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Family-Centered Cesarean (Procedure); Traditional Cesarean (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 11-item Patient Satisfaction Questionnaire |
4.6; 4.4; 4.6; 4.3; 4.9; 4.7 | — |
| SECONDARY Timing of Initiation of Family Bond Following Delivery |
5.1; 16.3 | — |
| SECONDARY Number (Percent) of Patients Planning to Breastfeeding After Discharge |
47; 33 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02690077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.