Family-Centered Cesarean: A Randomized Controlled Trial
Phase: NA
Conditions: Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes
Sponsor: Wake Forest University Health Sciences

 
 
                         Page 1 
Protocol Title:  
Family-Centered Cesarean: A Randomized Controlled Trial 
 
Protocol Version: 
 
11 
 
Protocol Date:  
 
3/15/2019 
 
Locations: 
 
 
Aurora Sinai Medical Center, Milwaukee, Wisconsin 
 
 
 
 
Aurora BayCare Medical Center, Green Bay, Wisconsin 
 
 

 
 
                         Page 2 
I. 
BACKGROUND AND SIGNIFICANCE 
 
Cesarean sections are one of the most common surgical procedures performed world-wide. They 
are performed for both maternal and neonatal indications.  Today, cesarean sections account for 
20% of all births globally.1 From 1996-2009, the rates of cesarean sections in the United States 
rose approximately 60%; these rates have remained unchanged since 2010. The national rate of 
cesarean deliveries in 2012 was 32.8%.2 
 
As the number of cesarean sections increase and vaginal deliveries decrease, women report that 
they are less satisfied with their overall child birthing experience.1, 3-6 Mother and partner 
experiences differ between cesarean and vaginal delivery; the biggest difference is that, during 
vaginal delivery, the newborn is more often directly given to mom immediately after birth, which 
initiates early mother-newborn interactions through skin-to-skin contact and breastfeeding. 
Additionally, a mother and her support people are able to see their child enter the world without 
a barrier between them.  Cesarean sections create a delay in the mother-newborn interaction, as 
the newborn is routinely separated from the mother. Such separation leads to later skin-to-skin 
contact and makes it harder for mothers to initiate breastfeeding.1, 4 This separation also leads to 
greater dissatisfaction with the birthing process and a mother is more likely to feel she was 
unable to participate in the birth of her child.3  
 
 
To improve the overall child birthing experience, the family-centered/gentle cesarean delivery 
method mimics a vaginal birthing experience. Similar to a vaginal delivery, a mother can watch 
the birth, and the newborn is immediately placed on the mother’s chest following cesarean 
delivery. Studies have shown that immediate mother-newborn interactions and skin-to-skin 
contact is advantageous in promoting the bond between mother and newborn, breastfeeding, and 
overall patient satisfaction with the birthing process.1, 5 The family-centered/gentle cesarean 
method is relatively new. Limited information is available in regards to differences in maternal 
and neonatal outcomes when comparing traditional cesarean methods to that of the family-
centered/gentle cesarean. Additionally, available information often refers to this methodology as 
either family-centered cesarean or gentle cesarean; we will refer to this method as the family-
centered cesarean from here on out. 
 
One European study conducted in Germany compared family-centered and traditional cesarean 
delivery methods, and determined that no additional complications arose for mother or newborn 
when using the family-centered cesarean method.6 Although the Memorial Hospital of Rhode 
Island has implemented the family-centered cesarean method as the standard of care during 
cesarean delivery, to our knowledge, no studies have been conducted in the United States that 
compare the family-centered cesarean method to traditional methods of cesarean delivery.4 
Magee et al. further supports that the techniques used in their hospital have not been evaluated 
and that the hospital’s approach to family-centered cesarean deliveries should be further 
examined as it relates to maternal and neonatal outcomes, as well as overall patient satisfaction.4  
 
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 

 
 
                         Page 3 
with the traditional cesarean.  
 
II. 
SPECIFIC AIMS 
 
Primary Objective 
 
The primary objective of this study is to compare patient satisfaction of the family-centered 
cesarean birthing experience with that of the traditional cesarean experience.  
 
Secondary Objective 
 
The secondary objective of this study is to determine if skin-to-skin contact (i.e., family bond 
initiation) occurs earlier and in-hospital breastfeeding initiation is more likely with the family-
centered cesarean delivery method than traditional cesarean delivery method. 
 
Tertiary Objective 
 
The tertiary objective of this study is to determine if differences in maternal and neonatal 
outcomes exist between cesarean delivery methods (family-centered versus traditional cesarean). 
 
III. 
STUDY DESIGN 
 
Subject Enrollment  
Women undergoing a scheduled cesarean delivery at ≥38 weeks of gestation who present at 
Aurora Sinai Medical Center and Aurora BayCare Medical Center and have their babies 
delivered by obstetrics and gynecology physicians during June 1, 2016 through May 31, 2019 
will be enrolled in this study. Patients who meet the study criteria will be recruited via obstetrics 
and gynecology physicians on the day of their scheduled cesarean section. Patients who agree to 
participate in this study will be formally consented. The study will be described to the patient 
using the following script, containing objective language so as to minimize bias or influence 
when the patient is later asked to identify her preference of the 2 cesarean delivery methods. 
Note that Method 1 below describes the family-centered delivery method, while Method 2 
describes the traditional delivery method. 
 
“We are conducting a patient satisfaction study on two methods of cesarean 
section.  Both of these methods are used throughout the United States, and neither 
has been proven to be better than the other. Method 1 involves lowering part of 
the surgical drape exposing a transparent window through which you can watch 
the birth of your baby; the baby will be placed on your chest immediately after the 
delivery. Cleaning and evaluation of your baby will be done by a nurse who is 
standing next to you at the head of the bed. Method 2 involves keeping the 
surgical drape up throughout the entire surgery so that the birthing process will 
not be visible, and your baby will be taken to the warmer to be evaluated and 
cleaned after birth but is available to be laid on your chest at any point upon 
request.” 
 

 
 
                         Page 4 
Randomization to Method 
Eligible patients will be formally consented on the day of their scheduled cesarean sections by 
the research coordinator, resident physician(s), charge nurse or nurse. Following enrollment, 
each patient will be asked to state which method of cesarean delivery she would prefer, if given 
the option to choose. Preference represents a potential factor influencing patient satisfaction that 
will be later incorporated into the statistical analysis, based on a 2 x 2 factorial (Method x 
Preference) design. Documentation of preference at this time (versus following random 
assignment to cesarean delivery method) is important for minimizing the bias or influence of the 
random assignment upon the patient’s declared preference.  
 
The patient will be randomized to 1 of the 2 delivery methods by the research coordinator, 
resident physician(s), charge nurse or nurse, who will present the patient with a sealed envelope. 
The envelope will contain a slip of paper identifying the patient’s random assignment to either 
the family-centered cesarean delivery method (Method 1) or the traditional delivery method 
(Method 2). Fifty percent of all envelopes preassembled for patients will contain paper slips 
stating “Family-centered”, while the remaining 50% will contain slips stating “Traditional,” 
allowing for a 1:1 allocation of delivery methods. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subject Recruitment & 
Enrollment 
Method 1: Family-centered 
Cesarean Delivery 
Method 2: Traditional Cesarean 
Delivery  
Preference: 
Traditional 
 
(comprising Y% 
of women in 
Method 2)  
Preference: 
Family-
centered  
(comprising X% 
of women in 
Method 2)  
Preference: 
Traditional  
 
(comprising Y% 
of women in 
Method 1)  
Preference: 
Family-
centered  
(comprising X% 
of women in 
Method 1)  
Subjects Randomized 1:1 to 
Family-centered and Traditional 
Cesarean Delivery Groups 

 
 
                         Page 5 
Assessment of patient satisfaction following delivery 
The primary objective of this study is to compare levels of patient satisfaction with the birthing 
experience between the two cesarean delivery methods. To assess patient satisfaction, each 
patient will be verbally surveyed by the study coordinator using an 11-item questionnaire. 
Similar to the questionnaire used by Armbrust and his colleagues6, items on our questionnaire 
will relate specifically to the mother’s birthing experience and answers available per item will be 
in the form of a modified Likert scale, ranging from 1, the lowest level of agreement or degree of 
satisfaction, to 5, the highest level of agreement or degree of satisfaction. The survey questions 
will be asked before discharge (approximately within 48 hours after the delivery), to allow 
sufficient opportunity for the mother and newborn to bond before discharge. 
 
IV. 
STUDY POPULATION 
 
Pregnant patients who plan to deliver at Aurora Sinai Medical Center (ASMC) and Aurora 
BayCare Medical Center (ABMC) will be enrolled in this study. ASMC is a 177-bed, urban 
community-based hospital located in Milwaukee, Wisconsin. In 2014, 2,479 deliveries were 
performed at this facility with 26.4% of births delivered via cesarean sections. ABMC is a 167-
bed, urban community-based hospital, located in Green Bay, Wisconsin. In 2014, 1,623 
deliveries were performed at this facility with 26.4% of births delivered via cesarean section. 
These numbers reflect all cesarean deliveries, but do not necessarily reflect deliveries that are 
planned, which may total less than ½ of all cesarean deliveries. 
Inclusion 
• 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 
• 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 
 
V. 
SAMPLE SIZE  
 
No randomized controlled trials have focused on outcomes associated with the family-centered 

 
 
                         Page 6 
cesarean method in the United States. Furthermore, the only randomized controlled trial 
published in the obstetrics literature was a study conducted in Berlin, Germany by Armbrust and 
his colleagues, who assessed the eligibility of 250 women with indication for planned cesarean 
section. From this initial population, 205 total women were randomized to the study groups of 
Charité (family-centered) cesarean delivery and traditional cesarean delivery.6  
 
In our study, a factorial design with 2 design variables (Cesarean Delivery Method [Gentle, 
Traditional] and Preference of Method [Gentle, Traditional]) will be used. A sample size of 508 
total patients (127 patients in each of the 4 Method x Preference combinations) has been 
determined necessary to detect a 0.5-point difference in mean satisfaction scores (on a 5-point 
scale) and a 15-minute difference in time-to-initiation of family bond between the 2 groups of 
each design variable, given 2-factor generalized linear modeling with normally-distributed (or 
log-transformed) responses, standard deviation of 2 points (for satisfaction score) and 1-hour (for 
family bond initiation), alpha of 0.05, and power of 0.80. Moreover, to detect a 15% difference 
in probability of breastfeeding prior to discharge between the 2 groups of each design variable 
using logistic regression, a sample size of 432 total patients (108 patients in each of the 4 Method 
x Preference combinations) would be necessary. To detect clinically-relevant differences for all 
outcomes (responses) of interest in the Primary and Secondary Objectives, we will target 508 
total patients. 
 
VI. 
DESCRIPTION OF DELIVERY METHODS 
 
Method 1: Family-centered cesarean 
Standard preoperative preparation will be performed in the patient’s room, including surgical site 
hair clipping, chlorhexidine wash (at ASMC only), IV placement, completion of pre-procedure 
operating room checklist, and administration of prophylactic antibiotics, antiemetics (at ASMC 
only), and fluids. The patient will then be taken to the operating room. The pulse oximeter will 
be placed on the mother, and the electrocardiogram leads will be placed away from anterior chest 
wall or via an EKG back-patch to allow space for newborn and mom skin contact. Regional 
spinal anesthesia will be administered in normal fashion. The mother will lie down on the bed 
and, once sufficient anesthesia block is obtained, her gown will be removed and a blanket will be 
provided for her to cover her chest, allowing for easier skin-to-skin contact after delivery. Prior 
to the lowering of the drape, the mother’s head will be elevated. Fetal heart tracing will be 
monitored until adequate block is obtained to confirm fetal well-being. 
 
Preoperative preparation will continue with abdomen preparation. We will then wait 3 minutes 
from wash to dry before placing the blue drape on the mother’s abdomen and attaching it to the 
IV poles, thereby screening the mother from the first part of the surgery. After the fetal head 
enters the uterine incision, the opaque layer of the drape will be lowered, exposing a transparent 
drape layer that will enable the mother and her support person to watch the birth. The drape will 
only be lowered and the rest of the family-centered technique carried out if no complications 
occur during the operation. In the event of unexpected complications, such as heavy bleeding or 
problems with delivery of the newborn’s head, the surgical drape will not be lowered. Provided 
that the technique is continued, the newborn’s head, followed by the rest of the body, will be 
delivered by the surgeon in full view of the mother. The umbilical cord will be clamped and cut 
by the surgeon, and the newborn will then be handed off to the nurse waiting by the mother’s 

 
 
                         Page 7 
head. The nurse will be holding a sterile drape to receive the newborn and prevent contamination 
of the surgeon’s hands. The nurse will then immediately place the newborn on the mother’s bare 
chest skin, or be given to the mother’s support person, where the newborn will be dried and 
warmed with fresh towels. The opaque layer the drape will then be raised back up, screening the 
mother from the remaining surgery.  
 
While on the mother’s chest, the newborn’s well-being will be initially evaluated by the nurse 
and respiratory therapist per hospital cesarean section protocol. APGAR scores will be obtained, 
and the pulse oximeter will be applied to the newborn’s right hand. Suctioning needed at that 
time will be performed using a bulb or mechanical suction. The nurse will remain near the 
patient’s head, as long as needed to ensure maternal and neonatal well-being. Should the mother 
develop complications that prevent her from being able to comfortably hold the newborn, such as 
nausea/vomiting, fatigue, or drowsiness from medications, the nurse will be available to help 
with the newborn. As long as the patient remains stable, the newborn will be laid on mother’s 
chest in a way that allows suckling. The newborn vitamin K administration and erythromycin 
ointment can be applied per hospital protocol, either while she is holding the newborn or after 
she is in recovery. The newborn will be weighed following surgery, while the mother is 
transferred to her bed, unless she requests it be done earlier.  
 
Method 2: Traditional cesarean 
Standard preoperative preparation will be performed in the patient’s room, including surgical site 
hair clipping, chlorhexidine wash (at ASMC only), IV placement, completion of pre-procedure 
operating room checklist, and administration of prophylactic antibiotics, antiemetics (at ASMC 
only), and fluids. The patient will then be taken to the operating room. The pulse oximeter will 
be placed on the mother’s finger, and electrocardiogram leads will be placed in the usual fashion 
on the chest. Regional spinal anesthesia will be administered in normal fashion. The mother will 
lie down on the bed, and fetal heart tracing will be monitored until adequate block is obtained to 
confirm fetal well-being. 
 
Preoperative preparation will continue with abdomen preparation. We will then wait 3 minutes 
from wash to dry before placing the blue drape on the mother’s abdomen and attaching it to the 
IV poles, thereby screening the mother from the entire surgery. After delivery, the newborn will 
be handed off to a nurse waiting at the side of the mother who will take the newborn to the 
warmer on the opposite side of the operating room. The newborn will be dried and warmed with 
fresh towels on the warmer, while being evaluated by the nurse and respiratory therapist per 
hospital cesarean section protocol. The nurse will then proceed with newborn measurements, 
weight, bath, and administration of vitamin K and erythromycin ointment. The newborn will be 
swaddled and kept in the warmer until the mom requests that the newborn be brought to her or 
until the surgery has been completed and the mom is ready to be transferred to the recovery 
room.  
 
VII. 
DATA COLLECTION 
 
Patients will be followed throughout their hospital stay. The following variables of interest will 
be retrospectively collected from EPIC or recorded during the surgery on the OR Worksheet (* - 
Note, the OR Worksheet was updated on 2/16/2018.):  

 
 
                         Page 8 
 
Maternal Variables of Interest 
• Medical record number 
• Date of birth 
• Delivery Hospital (0=ASMC; 1=ABMC) 
• Date of consent for scheduled cesarean section 
• Date of procedure 
• Calculated maternal age 
• Race 
• Ethnicity 
• Gravidity (Gx) 
• Parity (Pxxxx) 
• Gestational Age (XwXd) 
• Height (inches) 
• Weight (lbs) 
• Calculated BMI (kg/m2) 
• History of previous vaginal delivery (0=No; 1=Yes) 
• History of previous cesarean delivery (0=No; 1=Yes)  
• Reason for previous cesarean delivery 
• History of previous abdominal/pelvic surgery (0=No; 1=Yes) 
• Reason for planned cesarean delivery 
• Type of cesarean delivery technique (0=Family-centered; 1=Traditional) 
• Identified mother preference (0=Family-centered; 1=Traditional) 
• Type of cesarean delivery (0=NA; 1=Classical; 2=Low Transverse) 
• Type of skin incision (0=NA; 1=Pfannenstiel; 2=vertical) 
• Operative start time (00:00:00) 
• Operative stop time (00:00:00) 
• Duration of operation (minutes) 
• Estimated blood loss (mL) 
• Hemorrhage EBL >1000mL (0=No; 1=Yes) 
• Complications occurred (0=No; 1=Yes) 
• Type(s) of complication(s) that occurred 
• If the mother’s delivery technique was family-centered, was she switched to a 
traditional cesarean? (0=No; 1=Yes)* 
• Was mom offered to view the birth of her baby? (0=No; 1=Yes)* 
• If offered to view the birth of her baby, was the drape dropped? (0=No; 1=Yes)* 
• Was mom/other support person offered baby right away? (0=No; 1=Yes)* 
• Physician Name 
• Did family bond occur in the OR? (0=No; 1=Yes)* 
• Time from birth to initiation of family bond (minutes)* 
• Person who initiated family bond (0=Mother; 1=Father; 2=Other Support Person)* 
• Family bond interrupted in the OR (0=No; 1=Yes)* 
• Reason family bond interrupted in the OR* 
• If the family bond DID NOT occur, why not?* 

 
 
                         Page 9 
• Surgical site infection associated with this surgery (0=No; 1=Yes) 
• Time to skin-to-skin contact & all other related skin-to-skin variables identified  
• Breastfeeding status flowsheet data (3=Unknown; 2=No; 1=Yes) 
 
Neonatal Variables of Interest 
• Birth weight 
• 1-min APGAR 
• 5-min APGAR 
• Documented neonatal  infection (0=No, 1=Yes) 
• Newborn heart rate at 10 minutes* 
• Newborn respiratory rate at 10 minutes* 
• Newborn temperature at 10 minutes* 
• Time taken for newborn to reach oxygen saturation >90%* 
 
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, Jessica Kram, or one of 
the resident physicians or the nurses/charge nurses at ASMC and study coordinator, Taylor 
Romdenne, or one of the nurses or charge nurses at ABMC. Please see the questionnaire 
displayed in a separate document. 
 
Please note, that while we aim to obtain the OR worksheet and patient satisfaction survey from 
all patients enrolled in the study, there may be circumstances in which one or the other were not 
completed. If a patient has either the OR worksheet or the patient satisfaction survey completed, 
we will not exclude them from the study/analyses, but it will be adjusted for.  
 
We will perform interim analyses throughout the study. In order to identify those individuals 
who may not have been asked to participate within our study or who did not participate within 
our study (we will not know specifically who declined or who was not asked to participate), we 
are requesting data from our Quality Teams, within our labor and delivery units, and Research 
Analytics. Individuals who were classified as scheduled or planned non-emergent (green or 
yellow) cesarean deliveries will be identified, as planned emergent (those deemed red) cesarean 
deliveries are not eligible for the study. Additionally, all variables of interest identified above 
may be requested in addition to variables of interest that would allow us to further determine 
whether a patient was ever eligible for the study (see study inclusion and exclusion criteria).   
 
Please note, the OR Worksheet and patient satisfaction surveys were updated on 2/16/2018. 
Based on our interium analyses, we have decided to change  the OR worksheet and patient 
satisfaction surveys to further clarify how we want data to be collected/recorded. Our 
biostatistician carefully reviewed the changes to make sure that we are acquiring the same 
information, but in a clearer manner (i.e., there is less room for interpretation). Furthermore, 
changes on the translated patient satisfaction survey were reviewed by a certified Aurora 
Translator, who verified that the document was clear/the changes made are appropriate. 
 
VIII. STATISTICAL PLAN 
 

 
 
                         Page 10 
To describe our study population and assess equivalency in characteristics among patients in the 
4 Method x Preference combinations, we will compute frequencies, means with 95% confidence 
intervals, and medians with interquartile ranges, as appropriate per variable type. Differences 
among the groups will be tested using the Pearson chi-squared test of independence, Student’s t-
test, or Wilcoxon’s rank sum test, respectively. To generally describe the outcomes (responses) 
corresponding to each of our 3 study objectives, both within and across the 4 Method x 
Preference combinations, we will again compute frequencies, means with 95% confidence 
intervals, and medians with interquartile ranges, as appropriate per variable type. 
 
For each outcome of interest, we will also develop a mixed regression model to examine the 
fixed main and interaction effects of Method and Preference. All models will be structured with 
appropriate response distributions, likely including the lognormal (normal distribution with 
natural log-transformed response) for continuous responses (e.g., time, weight, vitals), 
multinomial for survey questions of satisfaction, and binomial for 2-category outcomes (e.g., 
breastfeeding). Following back-transformation or exponentiation of parameter estimates, model 
results will be interpreted, respectively, as the percentage difference between groups, ratio of 
odds of a lower value, and ratio of odds of an outcome occurring. Unobserved outcome 
heterogeneity will be captured by the delivering physician nested within hospital, each 
combination of which will define a separate random variable and model intercept. 
 
IX. 
POTENTIAL RISKS AND BENEFITS 
 
Risks associated with Method 1 (family-centered cesarean delivery) include unforeseen patient 
and/or family discomfort with viewing the surgical field. Patients will be made aware of the 
potential risk of such discomfort prior to consenting to participating in the study. Notably, risks 
of this nature are a normal component of any cesarean delivery. Therefore, we will discuss the 
risk of viewing discomfort with all patients regardless of study participation. An additional risk 
associated with participating in either method could be loss of confidentiality due to obtaining 
limited protected health information. However, to minimize risk, all data will be stored on a 
password protected computer. 
 
A potential benefit of our study is that we may be able gather level-1 evidence to support local, 
regional, and possibly broader use of a novel method of cesarean delivery, currently being 
explored nationally and internationally. We hypothesize that there will be improved maternal 
satisfaction using the family-centered method. We also hypothesize that neonatal morbidity will 
not be increased and benefits may include earlier skin-skin contact and greater likelihood of 
breastfeeding.  
 
X. 
REFERENCES 
1. Alba-Romero C, Camaño-Gutiérrz I, López-Hernández P, et al. Postcesarean Section 
Skin-to-Skin Contact of Mother and Child. Journal of Human Lactation. 2014; 30(3): 
283-286. 
2. Martin JA, Hamilton BE, Osterman MJK, et al. National Vital Statistics Report - 
Births: Final Data for 2012.  Centers for Disease Control and Prevention. 2013; 62(9). 
3. Smith J, Platt F, Fisk NM. The natural cesarean: a woman-centred technique.  BJOG. 
2008; 115:1037-1042.  

 
 
                         Page 11 
4. Magee SR, Battle C, Morton J, Nothnagle M. Promotion of Family-Centered Birth 
with Gentle Cesarean Delivery. Journal of American Board of Family Medicine. 
2014; 27(5): 690-693. 
5. Moran-Peters JA, Zauderer CR, Goldman S, et al. A Quality Improvement Project 
Focused on Women’s Perceptions of Skin-to-Skin Contact After Cesarean Birth. 
Nursing for Women’s Health. 2014; 18(4): 296-303. 
6. Armbrust R, Hinkson L, Von Weizsäcker K, Henrich W. The Charité cesarean birth: 
a family orientated approach of cesarean section. The Journal of Maternal-Fetal & 
Neonatal Medicine. 2015; 1-6.