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Completed

NCT Number: NCT02690077

Family-Centered Cesarean Delivery

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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Key information

Conditions

Patient Satisfaction Behavior Earlier Family Bond Initiation Health Behavior Maternal and Neonatal Outcomes Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aurora BayCare Medical Center, Green Bay, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family-Centered Cesarean

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.

Other names: Gentle Cesarean

Traditional Cesarean

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.

Other names: Cesarean Section

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Family-Centered Cesarean: A Randomized Controlled Trial

Acronym: FCC

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Feb 24, 2016
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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