Family-Centered Cesarean Delivery (FCC)

April 2, 2024 updated by: Aurora Health Care

Family-Centered Cesarean: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Method 1 by Preference 1
Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference.
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.
Other Names:
  • Gentle Cesarean
Active Comparator: Method 1 by Preference 2
Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference.
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.
Other Names:
  • Gentle Cesarean
Active Comparator: Method 2 by Preference 1
Delivery through the Traditional Cesarean for patients with known Family-Centered preference.
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.
Other Names:
  • Cesarean Section
Active Comparator: Method 2 by Preference 2
Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference.
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.
Other Names:
  • Cesarean Section

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurora Health Care

Investigators

  • Principal Investigator: Marie M Forgie, DO, Aurora Health Care, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

October 29, 2021

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimated)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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