Family-Centered Cesarean Delivery

Patient Satisfaction Clinical Trial

— FCC  

Official title:

Family-Centered Cesarean: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690077
• Other study ID #: 02-16
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: October 29, 2021

Study information

• Verified date: April 2024
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: October 29, 2021
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Earlier Family Bond Initiation
• Maternal and Neonatal Outcomes
• Patient Satisfaction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

References & Publications (6)

Armbrust R, Hinkson L, von Weizsacker K, Henrich W. The Charite cesarean birth: a family orientated approach of cesarean section. J Matern Fetal Neonatal Med. 2016;29(1):163-8. doi: 10.3109/14767058.2014.991917. Epub 2015 Jan 9. — View Citation

de Alba-Romero C, Camano-Gutierrez I, Lopez-Hernandez P, de Castro-Fernandez J, Barbero-Casado P, Salcedo-Vazquez ML, Sanchez-Lopez D, Cantero-Arribas P, Moral-Pumarega MT, Pallas-Alonso CR. Postcesarean Section Skin-to-Skin Contact of Mother and Child. J Hum Lact. 2014 Aug;30(3):283-286. doi: 10.1177/0890334414535506. Epub 2014 May 20. — View Citation

Kram JJF, Montgomery MO, Moreno ACP, Romdenne TA, Forgie MM. Family-centered cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Nov;3(6):100472. doi: 10.1016/j.ajogmf.2021.100472. Epub 2021 Aug 26. — View Citation

Magee SR, Battle C, Morton J, Nothnagle M. Promotion of family-centered birth with gentle cesarean delivery. J Am Board Fam Med. 2014 Sep-Oct;27(5):690-3. doi: 10.3122/jabfm.2014.05.140014. — View Citation

Moran-Peters JA, Zauderer CR, Goldman S, Baierlein J, Smith AE. A quality improvement project focused on women's perceptions of skin-to-skin contact after cesarean birth. Nurs Womens Health. 2014 Aug-Sep;18(4):294-303. doi: 10.1111/1751-486X.12135. — View Citation

Smith J, Plaat F, Fisk NM. The natural caesarean: a woman-centred technique. BJOG. 2008 Jul;115(8):1037-42; discussion 1042. doi: 10.1111/j.1471-0528.2008.01777.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11-item Patient Satisfaction Questionnaire	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	Timing of Initiation of Family Bond Following Delivery	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
Secondary	Number (Percent) of Patients Planning to Breastfeeding After Discharge	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)