Family-Centered Cesarean Delivery

Not Applicable

Completed

• Conditions: Maternal and Neonatal Outcomes; Earlier Family Bond Initiation; Patient Satisfaction
• Interventions: Procedure: Traditional Cesarean; Procedure: Family-Centered Cesarean

• Registration Number: NCT02690077
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Study Start: 2016-06-01
• Primary Completion: 2018-08-01
• Study Completion: 2021-10-29
• Results First Submitted: 2022-02-02
• Results First Submitted QC: 2022-06-20
• Results First Posted: 2023-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Method 2 by Preference 1	Traditional Cesarean	Delivery through the Traditional Cesarean for patients with known Family-Centered preference.
Method 1 by Preference 2	Family-Centered Cesarean	Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference.
Method 1 by Preference 1	Family-Centered Cesarean	Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference.
Method 2 by Preference 2	Traditional Cesarean	Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference.

Primary Outcome Measures

Name	Time	Method
11-item Patient Satisfaction Questionnaire	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).

Secondary Outcome Measures

Name	Time	Method
Number (Percent) of Patients Planning to Breastfeeding After Discharge	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.
Timing of Initiation of Family Bond Following Delivery	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.

Trial Locations

Locations (2)

Aurora BayCare Medical Center; 🇺🇸 Green Bay, Wisconsin, United States

Aurora Sinai Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States