Effect of Mother's Active Pushing at Cesarean Delivery
Phase: NA
Conditions: Caesarean Section, Mother-Child Relations, Post Operative Pain, Postpartum Depression
Sponsor: Hannover Medical School

Study protcol for ( Effect of the mother´s active pushing at cesarean delivery) Frauenklinik , MHH . 
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Study protocol 
 
 
„Effect of The mother’s active pushing                                                 
at cesarean delivery “ 
 
 
 
 
 
 
 
 
 
 
 
The target and the reasons for the study 

Study protcol for ( Effect of the mother´s active pushing at cesarean delivery) Frauenklinik , MHH . 
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Caesarean section (C-section) is one of the most commonly performed 
operations for women all over the world. Currently around every 3rd baby (31.3 % 
on average) born in German hospitals is delivered by C-section(1)(2). Women 
who deliver by C-section have been reported to express less satisfaction with 
their birth experience than women delivering vaginally (3). Some women also 
express strong feelings of loss, failure, and anger during C-section(4). These 
feelings are likely related to stress, pain, and fatigue associated with major 
surgery and the psychological status of the patient and a stressor or trigger in 
the development of postnatal depression (4). Also, some studies suggested that 
the mother-infant bonding is affected by the mode of the delivery being worse 
with C-section.  
In this study, we will evaluate how the participation of patients in the delivery 
process during the C-section by pushing will affect the patients’ experience. This 
is done in anticipation that this participation will alleviate the severity of the 
intraoperative discomfort, the postoperative pain, and improve the 
breastfeeding and patient’s satisfaction by granting the patient a higher feeling 
of control.  
There are different techniques for performing C-Section of which some 
Techniques are performed with the participation of the mother and others 
without. Currently, there is no consensus on a standardised technique with 
convincing evidence of its superiority. The first approach of this modification of 
the C-section was described in 2008 by Smith et al. and was termed the 
‘‘natural caesarean’’ (5).   
In 2016, a prospective randomised controlled trial was conducted at the Charity 
Berlin Hospital, aiming to evaluate the safety of patient’s delivery experience of 
the modified C-section (participation of the mother during C-section) and early 
skin-to-skin contact(STS). Parameters of perinatal outcome for both mother and 
infant were assessed using modified Likert-Scales and a standardized 
questionnaire. Primary outcome measures were birth experience and 
satisfaction for both parents. Parameters of breastfeeding, consecutive 
problems, APGAR Scores, blood loss and perioperative complications were 
secondary outcome measures. The trial concluded that birth experiences and  
breastfeeding was rated significantly higher in the modified C-section group 
with the active participation of the mother compared to a classical C-section (p 
< 0.05). However, there were no significant differences regarding the neonatal 
outcome, intraoperative and postoperative complications. Major critics against 

Study protcol for ( Effect of the mother´s active pushing at cesarean delivery) Frauenklinik , MHH . 
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this study are that the authors did not analyse one factor but a combination of 
several factors which hinders clear evaluation. In addition, by creating a whole 
construct called “the charity birth”, several scientists criticize that this will 
promote C-section in cases where vaginal birth would be the suggested option. 
(6) 
Therefore, we decided to only evaluate the effects of one technique during C-
section. This does not promote C-section, however, might improve outcomes 
for patients who have to undergo C-section and alleviate postoperative negative 
effects caused by this procedure. 
 
Characterisation of the subjects 
Patients, who are getting a scheduled C-Section and having no contraindication 
for valsalva manoeuvres are eligible for this study. The gestational week should 
be between 37 and 42 weeks. Patients have to provide informed consent to this 
study. Patients must have epidural anaesthesia. They must understand the 
German language in order to understand information during C-section and 
correctly fill-out the questionnaires. Emergent C-sections or pregnant women 
known with chronic pain, severe preeclampsia or HELLP-Syndrome will be 
excluded 
 
Inclusion criteria 
- Minimum age of 18 years 
- Written consent 
- Pregnant women between 37 – 42 weeks  
- No fetal abnormalities. 
- Scheduled primary C-Section (category 3&4 NICE guidelines) with 
epidural anaesthesia  
Excluding criteria  
- Emergent C-section 
- Contraindication for epidural anaesthesia.  
- Multiple pregnancies 
- Scheduled C-section with placenta previa, accreta, increta or percreta.  
- Secondary C-section 
- Contraindication for Valsalva manoeuvre  

Study protcol for ( Effect of the mother´s active pushing at cesarean delivery) Frauenklinik , MHH . 
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- Known psychiatric illnesses  
- Known chronic Pain, taking Pain killers regularly 
 
Studientyp 
Prospective randomized single-centre study  
 
Measurements, findings and observations 
During the C-section, the patient will be guided to push after the uterotomy, 
aiming to participate in the process of delivery during the surgery. Patients will 
fill out a survey designed to assess pain severity and satisfaction level.   
1. Intraoperative and Postoperative pain at different time points ( day 0,1,2 
postoperatively) depending on validated numerical pain Scale (7). 
2. Psychological status and the satisfaction of the patient postoperatively 
using the validated Edinburgh Postnatal Depression Scale (EPDS)(8). 
3. Neonatal outcome according to APGAR score and pH Level from the 
umbilical cord. 
4. the breastfeeding depending on Breastfeeding Self-Efficacy Scale, Short 
Form (BSES-SF) (9)(10). 
5. The duration of the surgery and its complications (intraoperative 
haemorrhage, wound complication, postpartum haemorrhage (PPH) and 
surgical injury). 
6. A surgeon questionnaire evaluating the actual performance of the 
procedure. 
 
A detailed description of the course of study 
Antenatally, pregnant women will be evaluated for their eligibility for this study. 
Patients planned for primary C-section will be informed on preoperative visits. 
(category 3&4 NICE guidelines). If so, written informed consent will be collected 
from the patients prior to their participation in this study. Patients will be 
informed about the postoperative assessment in order to evaluate the effects 
of C-section techniques. As described in the patient information, there will be 
general information about the procedure and that communication and 
maternal participation will be evaluated. An explanation of pushing or not-
pushing, which both represent standard-techniques, will not be provided in 

Study protcol for ( Effect of the mother´s active pushing at cesarean delivery) Frauenklinik , MHH . 
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detail, to avoid expectation bias. Patients will be randomized by the study 
assistant using a 1:1 strategy. Patients will be assigned an identifier number 
upon their enrolment to the study. The allocation of participants, to either the 
control or the test group, will be randomly allocated using R software. This is to 
eliminate any human interference or bias in patients allocation.  
All participating surgeons will attend specialized training during which the study 
principles and the variations in C-section technique will be explained. Directly 
before surgery, surgeons will be informed about the randomization results.  
Control group: non-pushing 
This method describes the standard technique routinely performed by about 70% 
of all C-sections. After uterotomy the child will be delivered by the doctor 
without special information given to the patient. Patients will be informed 
about the feeling of abdominal pressure. The assistant will perform abdominal 
pressure to help deliver the baby. The umbilical cord will be clamped and the 
baby will be handed over to the midwife. The midwife will try to enable early 
skin-to-skin contact and perform routine care for mother and child. 
Intervention group: pushing 
This method describes the standard technique routinely performed by about 30% 
of all C-sections. After uterotomy the patient is informed that the child will be 
delivered soon. The surgeon explains and encourages the mother to push when 
she is asked to deliver the baby. The assistant will help the mother with 
abdominal pressure. During delivery, which routinely happens with three 
pushes, the surgeon informs the mother about the progress (head, shoulders, 
belly). After delivery, the surgeon directly shows the baby to the mother and 
praises the mother for her efforts. The umbilical cord will be clamped and the 
early skin-to-skin contact will be enabled if medically accepted.  
 
Methods 
Since there is currently no standardized questionnaire for the assessment of the 
patient’s well-being after the C-section, that’s why we created the 
questionnaire in accordance of previous studies consisting of the following: 
- validated numerical pain Scale for assessment of the intraoperative and 
postoperative pain. 

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Preoperative 
preparations 
 At 0,1 and 2 day 
postoperative 
Collection 
and 
analysis of 
the data  
Inclusion of 
the patients 
according to 
the 
inclusion/exc
lusion 
criteria   
Consent of the 
patient , 
explanation to 
the patient of 
the possibility 
to be selected 
for the test or 
control group  
Control 
group 
Filling out 
the survey 
Test 
group 
 Using SPSS 
Directly before surgery the 
surgeon will be informed 
about randomization result 
- validated Edinburgh Postnatal Depression Scale (EPDS) for assessment 
of the Psychological status and the satisfaction of the patient 
postoperatively. 
- Self-Efficacy Scale, Short Form (BSES-SF) for assessment of the 
breastfeeding at day 1-2 postoperative. Since the (BSES-SF) not 
validated in the German language, we will translate the questionnaire in 
Germany and validate it as a part of this study.  
- We added extra questions on the questionnaire using a Likert scale for 
assessment of the patient’s feelings during and after the surgery. 
 
After 
surgery 
objective 
assessments 
will 
be 
documented 
including 
postoperative complications, blood loss, fetal outcome. The surgeon will fill out 
a survey investigating the surgeons’ impression. Directly after child delivery 
patients will be first asked about the pain sensation durcing the delivery 
accordingt to a VAS scale. Postoperatively at4-6 hours after the surgery, 
patients will fill out the first survey. At day 1 and day 2 postoperatively, patients 
will fill out the following surveys. Data, which is collected from the surveys, will 
be encoded pseudo-anonymous. Recording of the complications will be 
performed in the first 3 days after delivery, as the usual hospital stay ranges 
between 3-5 days. This period covers all usual postoperative complications.  
Recording postpartum pain medications is essential as we cannot predict who 
will require which level of pain relivers (mild analgesics without opioids, weak 
opioids and strong opioids).  
 
 
 
 
 
 
 
 
The aim of the study: 
1:1 

Study protcol for ( Effect of the mother´s active pushing at cesarean delivery) Frauenklinik , MHH . 
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The aim of this study is to evaluate if the mother’s active pushing during the C-
section reduces pain during child delivery  
 
Primary endpoints 
- The severity of the intraoperative pain 
Secondary endpoints: 
- The severity of the postoperative pain 
- Patient’s satisfaction with the operation and her participation 
- Patient’s psychological status postoperatively  
- Breastfeeding after early Skin to Skin contact (SSC) 
- Neonatal Outcome 
- Duration of the hospital stay, duration of the surgery and its 
complications (intraoperative Haemorrhage, wound complication, PPH 
and surgical injury) 
- Surgeon’s satisfaction with the procedure 
 
The data collection and documentation  
Data will be collected after taking the patient’s written informed consent. 
Patients will be given pseudonyms. Only the study leader will have access to the 
files.  
 
Data privacy: 
Before a patient is enrolled in the study, written informed consent will be 
collected with the patient’s verbal acceptance and signature to join the study. 
No personal or identifiable data will be published or passed on to third parties. 
The approval of the participants can be cancelled at any time. This cancellation 
will not influence further medical care. In the event of a dropout, the patient’s 
data will be deleted and will not be included in the analysis. The data will only 
be used for scientific purposes. The results will be published in research reports, 
posters and scientific publications in accordance with the Data protection and 
privacy policy. The collected data will be archived for 10 years. 
 

Study protcol for ( Effect of the mother´s active pushing at cesarean delivery) Frauenklinik , MHH . 
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Unwanted events 
There are no expected specific complications regarding this technique since 
both techniques are routinely used. However, potential surgical complications 
associated with cesarean section are:  
- Maternal complication (Endometritis, wound complication, haemorrhage, 
infection, surgical injury of the urinary bladder, the small intestine and 
rarely 
the 
ureter), 
thromboembolism, 
Ileus, 
septic 
pelvic 
thrombophlebitis and rarely hysterectomy 
- Fetal and neonatal risks (iatrogenic prematurity, Iatrogenic birth trauma, 
transient tachypnoea of the newborn and neonatal adaption syndrome) 
- Anaesthetic complications. 
- Complications regarding the Valsalva manoeuvre are only described for 
prolonged pushing during vaginal delivery. These complications are very 
unlikely during C-section. (11) 
Only patients with indicated C-section will be included. Thereby, patients will 
not be exposed to additional risk as described above compared to vaginal 
delivery.  
 
Evaluation /Biometrics 
Descriptive statistics will be used to assess patients characteristics. Student T-
test or Mann Whitney U test will be used to for continuous data to compare 
parametric or nonparametric data sets, respectively and the chi-square test will 
be applied for categorical data.  
The primary evaluation should be based on the intention-to-treat population, 
i.e. all patients who were randomized will be included in the evaluation. With 
regard to the primary end point, a very timely recording will take place, so that 
only a negligible number of missing values can be assumed.  
In case of doubt or missing values, it will be replaced by the maximum observed 
VAS values in the study, which is a relatively simple elimination procedure and is 
easy to implement. As sensitivity analyses other imputation methods will be 
performed. 
We will conduct ANCOVA analyses to see how postoperative pain medication 
influences the study outcome. The WHO pain medication scale will be used to 
group the patients. 

Study protcol for ( Effect of the mother´s active pushing at cesarean delivery) Frauenklinik , MHH . 
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Power calculations  
Biometric Analysis was performed with the kind assistance of Dr. Theodor 
Framke, Institut für Biometrie ,MHH. Please see the attached document. 
There is a study from Berlin (6) on the subject, but this analysed a self-created 
composite variable on satisfaction and did not evaluate the sensation of pain 
seperately. There are no known studies which assessed the intraoperative pain 
during child delivery. The best approximation remains the direct postoperative 
pain. An older study (12) was a randomized four-therapy-arm study (placebo, 
diclofenac, propacetamol or diclofenac and paracetamol directly after delivery) 
which assessed postoperative pain after caesarean section at several time 
points. This study reflects the routine pain medication used in our clinics and 
was therefore selected.  
In the study analysing postoperative pain after caesarean section the mean VAS 
scores at 6 hours ranged between 3.4 and 3.9 with a standard deviation of 1.7-
2.0. Since we want to evaluate intraoperative pain, we exspect higher mean VAS 
scores between 6-7. We will calculate with a standard deviation of 2.0. Based on 
the findings of Armbrust et al and our clinical experience we expect a 
therapeutic effect of 15-20% which results in a mean VAS reduction of 0.8. 
Applying a two-sided T-Test for independent samples at a significance level of 
0.05, a mean difference iof 0.8 between the groups and a standard deviation of 
2, we will need 100 patients per treatment arm to detect a difference between 
both treatment groups with a power of 80%.  
There is currently no prognostic factor that is known in advance to influence 
outcome in a certain direction. Thus, stratification is not planned. 
 
 
+ 
 
 
 
 

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MR DiMatteo. Cesarean childbirth and psychosocial outcomes: a meta-
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12. Diclofenac and/or propacetamol for postoperative pain management after 
cesarean delivery in patients receiving patient controlled analgesia 

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morphine, Sahar M. Siddik M.D., F.R.C.A., Marie T. Aouad M.D., 2001 
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