Family-Centered Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Family-Centered Cesarean: A Randomized Controlled Trial

Conditions
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Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes

Intervention / Treatment
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* Procedure: Family-Centered Cesarean
* Procedure: Traditional Cesarean


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Method 1 by Preference 1<br>Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference. | Procedure: Family-Centered Cesarean<br>* 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.<br>* Other names: Gentle Cesarean;|
| Active Comparator: Method 1 by Preference 2<br>Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference. | Procedure: Family-Centered Cesarean<br>* 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.<br>* Other names: Gentle Cesarean;|
| Active Comparator: Method 2 by Preference 1<br>Delivery through the Traditional Cesarean for patients with known Family-Centered preference. | Procedure: Traditional Cesarean<br>* 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.<br>* Other names: Cesarean Section;|
| Active Comparator: Method 2 by Preference 2<br>Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference. | Procedure: Traditional Cesarean<br>* 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.<br>* Other names: Cesarean Section;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Assessed at time of discharge from the hospital (typically 3-5 days post-delivery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Assessed at time of discharge from the hospital (typically 3-5 days post-delivery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes