Family-Centered Cesarean Delivery (FCC)

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Advocate Aurora Health

Status

Completed

Conditions

Patient Satisfaction
Earlier Family Bond Initiation
Maternal and Neonatal Outcomes

Treatments

Procedure: Family-Centered Cesarean
Procedure: Traditional Cesarean

Study type

Interventional

Funder types

Other

Identifiers

NCT02690077
02-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

149 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

149 participants in 4 patient groups

Method 1 by Preference 1
Active Comparator group
Description:
Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference.
Treatment:
Procedure: Family-Centered Cesarean
Method 1 by Preference 2
Active Comparator group
Description:
Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference.
Treatment:
Procedure: Family-Centered Cesarean
Method 2 by Preference 1
Active Comparator group
Description:
Delivery through the Traditional Cesarean for patients with known Family-Centered preference.
Treatment:
Procedure: Traditional Cesarean
Method 2 by Preference 2
Active Comparator group
Description:
Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference.
Treatment:
Procedure: Traditional Cesarean

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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