Family-Centered Cesarean Delivery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2021-10-29

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.

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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.

Conditions

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Patient Satisfaction Earlier Family Bond Initiation Maternal and Neonatal Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Method 1 by Preference 1

Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference.

Group Type ACTIVE_COMPARATOR

Family-Centered Cesarean

Intervention Type PROCEDURE

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.

Method 1 by Preference 2

Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference.

Group Type ACTIVE_COMPARATOR

Family-Centered Cesarean

Intervention Type PROCEDURE

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.

Method 2 by Preference 1

Delivery through the Traditional Cesarean for patients with known Family-Centered preference.

Group Type ACTIVE_COMPARATOR

Traditional Cesarean

Intervention Type PROCEDURE

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.

Method 2 by Preference 2

Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference.

Group Type ACTIVE_COMPARATOR

Traditional Cesarean

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Gentle Cesarean Cesarean Section

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes