Trials / Completed
CompletedNCT02690077
Family-Centered Cesarean Delivery
Family-Centered Cesarean: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
| PROCEDURE | 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. |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2018-08-01
- Completion
- 2021-10-29
- First posted
- 2016-02-24
- Last updated
- 2024-10-03
- Results posted
- 2023-03-31
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02690077. Inclusion in this directory is not an endorsement.