Family-Centered Cesarean: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 149
- Locations
- 4
- Primary Endpoint
- 11-item Patient Satisfaction Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
11-item Patient Satisfaction Questionnaire
Time Frame: 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 Outcomes
- Number (Percent) of Patients Planning to Breastfeeding After Discharge(Assessed at time of discharge from the hospital (typically 3-5 days post-delivery))
- Timing of Initiation of Family Bond Following Delivery(Assessed in Operating Room)