Effectiveness of a Breathing and Relaxation Technique in Antenatal Education (BreLax Study): a Randomised Controlled Trial
Phase: NA
Conditions: Pregnancy
Sponsor: Zurich University of Applied Sciences

 
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Evaluation of an antenatal education class including a breathing and relaxation technique (BreLax study)  
Study ID 2023 - 000183124 
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Evaluation of an antenatal education class including a breathing and 
relaxation technique (BreLax study)  
 
 
 
Study Type: 
Other Clinical Trial according to ClinO, Chapter 4 
 
Risk Categorisation:  
Category A 
 
Study Registration: 
1. The study will be registered in the clinicaltrial.gov registry. The 
registration will be finished after the Ethical approval (Nr. ) 
2. The study will be registered in the FOPH portal SNCTP (Swiss 
National Clinical Trial Portal) after ethical approval 
 
Sponsor-Investigator: 
Vanessa Leutenegger, RM, MScN, PhD Student, Research Unit 
for Midwifery, Institute of Midwifery and Reproductive Health, 
School of Health Professions, ZHAW Zurich University of Applied 
Sciences, Winterthur 
 
Principal Investigator 
Vanessa Leutenegger, RM, MScN, PhD Student, Research Unit 
for Midwifery, Institute of Midwifery and Reproductive Health, 
School of Health Professions, ZHAW Zurich University of Applied 
Sciences, Winterthur 
 
Investigated Intervention: 
Evaluation of an antenatal education class including a breathing 
and relaxation technique.  
 
Protocol ID 
 
 
2023 - 000183124 
 
Version and Date: 
 
Version 2.0 10/10/23 
 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document is confidential and the property of Vanessa 
Leutenegger, MScN, PhD Student. The information may not - in full or in part - be transmitted, 
reproduced, published, or disclosed to others than the applicable Competent Ethics Committee(s) 
and Regulatory Authority(ies) without prior written authorisation from the sponsor except to the 
extent necessary to obtain informed consent from those who will participate in the study. 
 

 
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TABLE OF CONTENTS 
GLOSSARY OF ABBREVATIONS 
3 
1 BACKGROUND AND RATIONALE 
4 
1.1 
Introduction 
4 
1.2 
Background 
4 
2 STUDY OBJECTIVES AND DESIGN 
5 
2.1 
Hypothesis and primary objective 
5 
2.2 
Primary and secondary endpoints 
5 
2.3 
Study design 
5 
2.4 
Study intervention 
6 
2.4.1 
Breath awareness (BA) 
7 
2.4.2 
Informational component 
8 
3 STUDY POPULATION AND STUDY PROCEDURES 
8 
3.1 
Inclusion and exclusion criteria, justification of study population 
8 
3.2 
Recruitment, screening and informed consent procedure 
9 
3.3 
Study procedures 
9 
3.3.1 
Potential bias and measures, to reduce them: 
11 
3.4 
Withdrawal and discontinuation 
12 
4 STATISTICS AND METHODOLOGY 
12 
4.1 
Statistical analysis plan and sample size calculation 
12 
4.2 
Handling of missing data and drop-outs 
13 
5 REGULATORY ASPECTS AND SAFETY 
13 
5.1 
Local regulations / Declaration of Helsinki 
13 
5.2 
(Serious) Adverse Events and notification of safety and protective measures 
13 
5.3 
(Periodic) safety reporting 
14 
5.4 
Radiation 
14 
5.5 
Pregnancy 
14 
5.6 
Amendments 
15 
5.7 
Notification and reporting upon completion, discontinuation or interruption of the 
study 
15 
5.8 
Insurance 
15 
6 FURTHER ASPECTS 
15 
6.1 
Overall ethical considerations 
15 
6.2 
Risk-benefit assessment 
16 
7 QUALITY CONTROL AND DATA PROTECTION 
16 
7.1 
Quality measures 
16 
7.2 
Data recording and source data 
17 
7.3 
Confidentiality and coding 
17 
7.4 
Retention and destruction of study data and biological material 
18 
8 MONITORING AND REGISTRATION 
18 
9 FUNDING / PUBLICATION / DECLARATION OF INTEREST 
18 
11. REFERENCES 
19 
Appendix 1: Schedule of assessments 
21 

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GLOSSARY OF ABBREVATIONS 
 
AE 
Adverse Event 
ASR 
Annual Safety Repot 
BASEC 
Business Administration System for Ethical Committees 
CRF 
Case Report Form 
CTCAE 
Common Terminology Criteria for Adverse Events 
FADP 
Federal Act on Data Protection (in German: DSG, in French: LPD, in Italian: LPD) 
eCRF 
electronic Case Report Form 
FOPH 
Federal Office of Public Health 
GCP 
Good Clinical Practice 
HRA 
Human Research Act (in German: HFG, in French: LRH, in Italian: LRUm) 
ICH 
International Conference on Harmonisation  
ClinO 
Ordinance on Clinical Trials in Human Research (in German: KlinV, in French: 
OClin, in Italian: OSRUm) 
SAE 
Serious Adverse Event 
 
 

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1 
BACKGROUND AND RATIONALE  
1.1 
Introduction 
Antenatal education classes were developed to inform expectant mothers about pregnancy, 
labour and birth as well as the postpartum period with the aim of improving the pregnancy and 
childbirth experience (Ahldén et al., 2012; Ip et al., 2009). Conceptually, they were based, for 
example, on the pioneering work of Lamaze (1956) and Grantly Dick-Read (1944) (Svensson et 
al., 2009). Studies indicate positive emotional effects of antenatal education classes on labour 
and birth outcomes. This includes lower levels of fear of childbirth, lower rates of caesarean birth 
at the women`s request, a higher rate of spontaneous births, a stronger involvement of the 
partner, better chances of initiating breastfeeding, and a lower likelihood of developing depression 
symptoms during the postpartum period (Ip et al., 2009; Rouhe et al., 2013; Svensson et al., 
2008). However, a standardized, evidence-based education program is missing. There is limited 
evidence on the link between birth preparation and neonatal outcomes (Shand et al., 2022).  
1.2 
Background 
Today, women and their partners are offered antenatal education classes during pregnancy, 
which in Switzerland are partly financed by the health insurance. In most cases, the courses are 
offered by midwives and consist of a series of sessions starting in the second trimester of 
pregnancy. They are usually weekly courses over 6-10 evenings or weekend courses over two to 
three days. However, the content of antenatal classes vary widely, as does the focus and the start 
and duration of the program. The goal of the classes offered today is to increase knowledge and 
confidence in relation to pregnancy, labour and birth as well as the postpartum period (Ricchi et 
al., 2019), especially through information and preparation in managing labour pain through skilled 
techniques (Shand et al., 2022). Therefore, antenatal education classes, which focus on breathing 
and relaxation techniques, offer an optimal opportunity to prepare for labour and birth and the 
pain management. 
Exercising breathing and relaxation techniques frequently and intensively before childbirth 
improves the feasibility of using them during birth. This leads to beneficial effects such as 
increased coping with labour pain and increased self-efficacy (Byrne et al., 2014). Women felt 
more in control as they were able to use the trained skills appropriate to their individual needs, 
which consequently increased their ability to feel in control, as well as being able to manage their 
own labour and birth (Howarth & Swain, 2019a). Self-efficacy is an important concept in labour 
and birth management when women want to feel confident that they will be able to maintain 
control during labour by managing their labour pain (Ip et al., 2009).  
In maternity care, practices around birth preparation are based on experience, but they have 
hardly been systematically developed, implemented, and evaluated (Nolan, 2009). Although 
several studies have shown positive effects on self-efficacy, lower rates of epidural anaesthesia 
and the memory of labour pain (Abbasi et al., 2018; Bergström et al., 2009; Duncan et al., 2017; 
Howarth & Swain, 2019b; Levett et al., 2016; Miquelutti et al., 2013; Pan et al., 2019) the important 
role of self-efficacy in women's ability to cope with labour and birth has hardly been integrated 
into the development of antenatal education classes (Ip et al., 2009). Moreover, evidence of a 
potential relation between antenatal education classes and neonatal outcomes has been hard to 
identify so far (Gluck et al., 2020; Shand et al., 2022; Vanderlaan et al., 2022; Yohai et al., 2018).  
The best available evidence for the impact of antenatal classes is from research with women who 
fear childbirth. For this group of women, a group psychoeducation course paired with skilled 
breathing and relaxation techniques had a positive effect on the women's pregnancy outcomes 
and childbirth experience (Ryding et al., 2018). Antenatal education classes focusing on breathing 
and relaxation techniques is thereby assumed to strengthen the resources of women with 
increased fear of childbirth and enable them to act competently and proactively during childbirth. 
In line with this argument, studies have shown that women who fear childbirth, especially first-
time mothers, benefit from the relieving effects of breathing and relaxation on labour pain and 

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anxiety, (Salmela-Aro et al., 2012). Building on this recent evidence, we assume that antenatal 
education classes may also positively influence maternal and neonatal birth outcomes in women 
without heightened fear of childbirth. We therefore intend to conduct an antenatal education class 
focusing on a breathing and relaxation technique and assess the impact of such a class on self-
efficacy, as well as other maternal and neonatal birth outcomes.  
2 
STUDY OBJECTIVES AND DESIGN  
2.1 
Hypothesis and primary objective 
The following hypothesis was formed for the BreLax study:  
• 
Women who attend an antenatal education class that include training in breathing and 
relaxation techniques show significantly higher self-efficacy rates than women in a 
standard antenatal education class that does not include training in breathing and 
relaxation techniques. 
 
The main objective of the study is therefore to evaluate the effectiveness of antenatal education 
classes that include a breathing and relaxation technique, in relation to maternal and neonatal 
outcomes.  
2.2 
Primary and secondary endpoints 
The primary objective is to compare the effects of antenatal education that includes a breathing 
and relaxation technique on self-efficacy before, during, and after birth to a standard antenatal 
education class without a focus on breathing and relaxation techniques and after birth. 
In this study, self-efficacy is defined as follows. Self-efficacy is a person's own belief that he or 
she is able to cope with difficult situations and challenges on his or her own (Bandura, 1977). This 
means women are confident and believe that they can cope with birth by themselves. 
 
The secondary objectives are:  
(2) To identify the impact of BreLax on maternal outcomes: women`s satisfaction with their 
childbirth experience, self-control, pain management, mobility during labour, duration of 
labour and fetal attachment. 
(3) To analyse the effects of BreLax on neonatal outcomes: 5-minute Apgar-Score and 
arterial umbilical cord pH.  
(4) To determine women's perceptions of the acceptability and applicability of the learned 
breathing and relaxation techniques before and during labour. 
(5) To assess the feasibility and effectiveness perceptions of the birth attending midwives 
regarding the intervention. 
 
As background variables and potential covariates factors such as mother’s sociodemographic 
data (e.g., age, family type, education, and occupation), the presence of chronic diseases as well 
as perinatal factors will be assessed. Correspondingly, relevant newborn indicators such as 
gestational age or birth weight will be measured. 
 
 

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2.3 
Study design  
The study will be conducted as a population-based randomised controlled trial (RCT) with a pre-
post design and two parallel-arms: The intervention arm is an antenatal education class that 
includes a breathing and relaxation technique. The control arm is an antenatal education class 
that is like the one in the intervention arm but does not include a breathing and relaxation 
technique.  
As quantitative pre-post outcome measures, mothers will fill in two validated questionnaires 
before and after birth:  
• 
German version of the Childbirth Self-Efficacy Inventory (CBSEI-32) (Schmidt et al., 
2016)  
• 
German version of the Childbirth Experience Questionnaire (CEQ-2) (Pedersen et al., 
2021). 
Complementary, using a qualitative method approach, birth attendant midwives’ perceptions on 
the feasibility and practicability of including the breathing and relaxation intervention in antenatal 
education classes will be assessed in semi-structured interviews.  
2.4 
Study intervention 
It is recommended to start attending antenatal education in the second trimester. This applies to 
both the intervention and the control group. The women and their partners will be randomly 
assigned to one of two groups. One group serves as control group (standard care) and will receive 
a standard antenatal education class without a breathing and relaxation technique and exercises 
while the other group will receive antenatal education plus the designed intervention of a 
breathing and relaxation technique and exercises (BreLax: intervention group). Both groups 
receive information on labour and birth and the postpartum period. 
The developed multicomponent intervention is based on the theoretical concept of Bandura `s 
self-efficacy theory (1977). According to Bandura (1977), self-efficacy is considered to be the 
expectation of whether an individual is capable of performing a particular behaviour in a given 
situation, which can be divided into outcome expectation and self-efficacy expectation. Outcome 
expectations refer to the individual's prediction of the possible outcomes of a set of behaviours. If 
someone predicts that a certain behaviour would lead to a certain outcome, that behaviour may 
be activated and chosen. Self-efficacy is primarily influenced by four sources of information, 
namely performance, vicarious experience, verbal persuasion and physiological and emotional 
states (Bandura, 1977).   
According to Bandura (1997), a strong belief in one's own ability to exercise some control over 
one's physical condition can serve as a psychological prognostic indicator of the likely level of 
health functioning (Ip et al., 2009). In line with these assumptions, self-efficacy has been shown 
to have an important influence on how labour is perceived and physically endured (Leutenegger 
et al., 2022). Therefore, we assume that any strategy that reduces and/or controls distractions 
during birth such as emotional tension, can increase self-efficacy. Consequently, breathing and 
relaxation techniques are predicted to improve women’s self-efficacy beliefs as they contribute to 
the control and reduction of distractions that hinder birth.   
In order to increase women’s self-efficacy beliefs that they trust themselves to be able to manage 
the birth process, the BreLax intervention will use all four sources of self-efficacy improving 
information. Women will experience that they can successfully perform the breathing and 
relaxation techniques and see that similar other can do it, too. They will also perceive reassuring 
comments from the class instructors and will feel less distractive emotions and physical arousal.  
The core of the breathing technique is prolonged exhalation and with a certain number of 
repetitions and amplitudes (Evans, 2014). Such techniques has been taught for many years in 
antenatal education and are actively supported by many midwives during labour and birth. In the 
present study, the focus is on prolonged exhalation with an individual rhythm, which is learned 
and practised by the women during antenatal education. In addition, the women will be 
encouraged to continue practising at home with the help of a manual.  

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The main advantage of this technique is to be prepared for labour and birth, use it actively even 
in stressful situation, to learn an individual breathing pattern and to relax comfortably. Breathing 
technique means breathing with a certain number of repetitions and amplitudes (Evans, 2014).  
2.4.1 Breath awareness (BA) 
Breath awareness provides physical, mental and emotional control. Deep breathing increases 
blood circulation, oxygen flow and reduces stress, which benefits both mother and baby. By 
learning conscious breathing and relaxation techniques, women can learn to control themselves 
when uterine contractions start, control their pain and relax, which boosts their confidence (Irmak 
Vural & Aslan, 2019).  
 
• 
Exercises to learn prolonged exhalation (following the 3-6 breathing technique for 
relaxation) 
• 
Exercises for mental and physical relaxation (4 upright positions, standing, sitting, 4-foot, 
elevated lateral position) 
• 
Optional: visualisation, music 
 
 
Figure 1 Standing Position ©BreLax 
 
Figure 2 4-Feet Position @BreLax 
 
Figure 3 Sitting Position ©BreLax 
 
Figure 4 Lying Position ©BreLax 
 
Women need to learn to use their breathing individually. Breathing and relaxation techniques are 
only useful and practical if women can try them out and apply them in different everyday situations. 
Breathing and relaxation techniques can be used on any day and in any stressful or uncomfortable 
situation (Doriana et al., 2010). For this reason, it is important that women continue to practice at 
home. In the best case, the breathing and relaxation techniques become a kind of routine or 
become so automated that the techniques are remembered during birth and can be used 
accordingly. For a kind of habit to form, it is necessary for women to practice over a period of time 
(Mazar & Wood, 2018). Previous literature shows that an average of 66 days is required to recall 
automated exercises (Gardner et al., 2020). This time period coincides optimally with the 
recommended start of the antenatal education class in the second trimester.  

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2.4.2 Informational component 
The intervention and the standard care aim to inform women about pregnancy, labour and birth 
and the postpartum period. The main difference is that the intervention group focuses on the 
element of a breathing and relaxation technique (See Table 1). Midwives instruct the participants 
on how to do the exercises, how to perform the breathing patterns and how to assume the 
respective positions and movements. In addition, the women receive a manual to practice at 
home. The control group receives the standard care.  
 
Table 1 Content of classes 
 
3 
STUDY POPULATION AND STUDY PROCEDURES 
3.1 
Inclusion and exclusion criteria, justification of study population 
Inclusion and exclusion criteria are defined for the randomized controlled trial as well as the 
individual interviews with midwives after birth.  
 
The quantitative data collection: 
• 
Inclusion criteria: 
o pregnant women with a singleton low-risk pregnancy 
o receiving antenatal care 
o being willing to attend an antenatal education class and planning a vaginal birth at 
the Canton Hospital Winterthur  
o  ≥ 18 years old 
o sufficient oral and written German language knowledge 
Content. 
BreLax-Model (intervention) 
Standard care (control) 
Pregnancy 
Nutrition 
✓ 
✓ 
Infections 
✓ 
✓ 
Being pregnant / Doing pregnancy  
✓ 
✓ 
Labour and birth 
Labour and birth 
✓ 
✓ 
Complications 
✓ 
✓ 
Non-pharmalogical medications 
✓ 
✓ 
Pharmalogical medications 
✓ 
✓ 
BreLax intervention 
✓ 
x 
Partner support 
✓ 
✓ 
BreLax Handout 
✓ 
x 
BreLax web-application 
✓ 
x 
Postpartum 
Baby food 
✓ 
✓ 
Baby care 
✓ 
✓ 
Attachment 
✓ 
✓ 
Sleep 
✓ 
✓ 
New Role as a mom/dad 
✓ 
✓ 

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• 
Exclusion criteria: 
o women, who plan an elective caesarean section 
o pregnant with multiples 
o younger than 18 years old 
o do not have sufficient oral and written German language knowledge 
 
The criteria for the individual interviews with the birth attendant midwives are that the midwife 
must have supported the woman for a minimum of 60 minutes and that she has sufficient written 
and oral German language skills. 
3.2 
Recruitment, screening and informed consent procedure 
Women will be recruited via the Cantonal Hospital Winterthur and midwives in antenatal care at 
the hospital, surrounding gynaecological practices and midwifery practices will be informed about 
the study and will receive flyers for circulation in the institutions. Midwives and doctors will hand 
out a flyer with information about the study and the call for interested women to contact the study 
leader at ZHAW. Contact information of interested women will only be provided to the study leader 
of ZHAW after women explicitly agreed and prefer to be contacted.  
 
The investigator will explain to each participant the nature of the study, its purpose, the 
procedures involved, the expected duration, the potential risks and benefits and any discomfort it 
may entail. Each participant will be informed that the participation in the study is voluntary and 
that she may withdraw from the study at any time and that withdrawal of consent will not affect 
her subsequent medical assistance and treatment. 
The participant will be informed that her medical records about their birth will be examined by 
authorised individuals other than their treating obstetrician. 
All participants for the study will be provided a participant information sheet and a consent form 
describing the study and providing sufficient information for participants to make an informed 
decision about their participation in the study. All potential participants will receive at least 24 
hours to decide whether to participate or not.  
The formal consent of a participant, using the approved consent form, will be obtained before the 
participant is submitted to any study procedure. The consent form will be signed and dated by the 
investigator simultaneously or after participants signature according to possibility. As this is a 
study of the risk category A and not all potential participants have scheduled visits in the hospitals, 
oral information can also be provided by telephone by the investigator. The study information and 
consent form in these cases will be sent by mail post and the participant will sign first and sent 
back the consent form. In order not to put pressure on the women, the investigator will only sign 
after the signed consent form has been returned. A copy of the signed informed consent will be 
given or sent to the study participant. The consent form will be retained as part of the study 
records. The informed consent process will be documented in the patient file and any discrepancy 
to the process described in the protocol will be explained. 
The links with the study information to the online surveys are sent to the women by the investigator 
or the research assistant. The online survey will be programmed in REDCap® (Research 
Electronic Data Capture) and anonymised. It will enable health care providers to consent to or 
decline participation in the online survey itself. 
 
Recruitment for the individual interviews with the birth attendant midwives in the Canton Hospital 
Winterthur will be conducted via the research assistant or the head of midwives.  
3.3 
Study procedures 
The study duration will be one and a half year. The recruitment period will be one year. 
Participants will be recruited in their second or beginning of third trimester of pregnancy. After 

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signing the consent form, participants will register for an antenatal education class. Due to the 
course organisation at the Cantonal Hospital Winterthur, randomisation is conducted at the 
course level. The randomisation is performed by envelopes with the corresponding information 
about the course (intervention yes or no). In the randomisation process the sponsor-investigator 
and local project leader will be excluded.  
Prior to the start of the classes, the participants fill in the online baseline questionnaire, which was 
sent to them by email. After the antenatal class, at around 36 weeks of gestation, the participants 
complete the education online questionnaire. The study assistant transfers the birth data 
anonymously directly from the clinic system to REDCap®. Finally, the postpartum online 
questionnaire is completed within four weeks after the birth (see Figure 1). 
 
 
Figure 5 Study process 
 
 

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The following table provides an overview on the study instruments and the timing of their 
application for data collection:  
 
Table 1 Study instruments and timing of application 
Questionnaires 
/ 
Interview 
Time of application 
Content 
Filled in by 
Baseline 
questionnaire (T0) 
After recruitment before 
the antenatal education 
class started 
Socio-demographic 
data, medical and 
obstetric history, 
German versions of the 
Childbirth-Self-Efficacy 
Inventory 
Participant 
Education 
questionnaire (T1) 
After intervention (around 
36 weeks of gestation) 
Data about the 
antenatal education 
class, German 
versions of the 
Childbirth-Self-Efficacy 
Inventory 
Participant 
Labour and birth 
questionnaire (T2) 
After birth 
Labour and birth 
outcomes for mother 
and child, early 
postpartum period 
Research assistant 
Postnatal 
questionnaire (T3) 
Early postnatal 
questionnaire (within 4 
weeks after birth) 
German version of the 
Childbirth experience 
questionnaire, 
postnatal quality of life, 
Data about the 
antenatal education 
class 
Participant 
Semi-structured 
interview guide 
After birth (within 10 
working days) 
Women's experience 
during birth, feasibility 
of the breathing and 
relaxation technique 
learned, self-efficacy 
and self-confidence 
observed 
Research assistant 
and birth attendant 
midwives  
 
3.3.1 Potential bias and measures, to reduce them: 
Sociodemographic questions as well as the validated questionnaires (German versions of the 
Childbirth-Self-Efficacy Inventory (Schmidt et al., 2016)) used for the validation of the antenatal 
education class will be applied before giving birth. To reduce the workload for the women, the 
study assistant transfers important information about the labour and birth directly from the medical 
birth report into the data entry tool. It is not possible to blind the midwives who conduct the 
antenatal education classes. However, after consent, the women are randomized and assigned 
to a class accordingly. In addition, the collected data will be entered by a research assistant, to 
ensure that data entry and data analysis are carried out by different people.   
Study dropouts and possible loss to follow-up are part of research projects. For this reason, an 
intention-to-treat principle is conducted to minimize attrition bias.  
Women after childbirth might evaluate their birth experience too optimistically. This could bias 
their satisfaction with the skilled breathing and relaxation technique and the attended antenatal 
education class. Beside questions about the antenatal education class, we will use a validated 

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questionnaire to assess labour and birth experience such as the childbirth experience 
questionnaire (Pedersen et al., 2021) to gain a more comprehensive insight. Additionally, we will 
use multivariable regression models to estimate the independent effect of the antenatal education 
class. 
3.4 
Withdrawal and discontinuation 
Participation in the study is voluntary and participants can withdraw from the study without any 
impairment of the quality of care. Potential reasons for not completing the study process or 
withdrawing from the study might be that women will withdraw from the study consent or not 
complete the antenatal education class. We estimate not completing the class will be rare. The 
loss of follow-up was considered in the sample calculation. Sociodemographic and pregnancy-
related characteristics, which were collected before these participants dropped out from the study, 
will be compared with those completing the whole study. This will provide information, if 
systematic patterns of dropping outs can be observed and inform the generalisability of the 
results. The comparison might also give information, if inclusion and exclusion criteria should be 
re-evaluated in follow-up studies. 
Data will be entered into REDCap®. The data base in REDCap® will be programmed at ZHAW 
and will enable data entry in the Canton Hospital Winterthur and data download by the sponsor-
investigator at ZHAW to download it in different formats. Data will then be stored on a secured 
pool at ZHAW. Data is stored on a dedicated, encrypted project file share provided by ZHAW’s 
IT department. Access is limited to project members (restricted access by IT) and requires ZHAW-
managed user accounts. Password policies are enforced, logins are monitored and logged. File 
access is logged and auditing enabled. External access requires two-factor authentication (SMS 
token). Data is physically stored on centralized storage, with data redundancy across ZHAW’s 
two data-centres, daily full backups and anti-ransomware measures in place. A centralized anti-
malware solution continuously scans files for malicious content. Storage capacity is up to 500 GB. 
Individual files/folders can be restored by users from hourly (up to 2 days), daily (up to 9 days) 
and weekly snapshots (up to two months). 
The participant identification list, which links the study numbers to personal details of women will 
be stored in a separate secured pool. If participants will withdraw from the study, their study key 
will be destroyed deleting all personal information from the study list and their anonymised data 
will be used for analyses that are possible with it. 
4 
STATISTICS AND METHODOLOGY 
4.1 
Statistical analysis plan and sample size calculation 
The socio-demographic and obstetric characteristics will be described employing descriptive 
statistics including frequency and percentage, mean and standard deviation, median and 
percentiles. The primary outcomes and secondary maternal and neonatal variables like women`s 
satisfaction with their childbirth experience, self-confidence, pain management, mobility during 
labour, duration of labour, bonding, 5-minute Apgar-Score and umbilical cord pH will be compared 
between the study groups using repeated-measures ANOVAs and generalized estimating 
equations and mixed effects models. Quantitative data is analysed using R. The significance level 
will be two-sided α = 0.05. 
The sample size in the intervention phase was calculated based on the scores for the variable of 
childbirth self-efficacy using G-Power software. Based on the randomised controlled trial of a self-
efﬁcacy enhancing educational programme (SEEEP) by Ip et al., (2009). This study reported an 
effect size of 0.78 in increasing self-efficacy in labour and an attrition rate of around 30.7%. In the 
proposed study, we therefore assume an overall moderate effect size of 0.75. Setting a power at 
80%, a significance level of p < .05, a sample size of 29 per arm is needed for a two-arm repeated 
measures design (GPower, version 3.1). Assuming an attrition rate of 20%, the final sample size 
will be 35 in each arm and 70 participants in total. 

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The qualitative data collected from the attendant birth midwives will be conducted by a semi-
structured interview guide. The data will be transcribed verbatim and analysed using content 
analysis (Kuckartz & Rädiker, 2022). The total target sample size for the individual interviews with 
midwives is 12-15. Variation enriches the results and can be achieved with 12 to 15 interviews. 
This is important to provide a good basis for the evaluation of the antenatal education class and 
the feasibility as well as the practicability of the skilled breathing and relaxation technique. 
Qualitative data will be analysed using MAXQDA. Any deviation from the original statistical plan 
will be described and justified in the final trial report. 
4.2 
Handling of missing data and drop-outs 
The data will be planned and analysed using the intent-to-treat principle (ITT). If missing data is 
>5%, the possibility of multiple imputation will be examined. We intend to minimise missing data 
and will for example design mandatory questions in the questionnaires and send reminders to 
participants to complete the follow-up questionnaires.  
The dropout rate is estimated at about 10 % and was taken into account accordingly in the sample 
size calculation. Recruitment has to take place during pregnancy in order to be able to observe 
the evaluation of the intervention. In obstetrics, it is never possible to predict how the birth will 
proceed and how the childbirth experience will affect the participants. Therefore, loss of follow-up 
for medical reasons cannot be avoided. The research assistants as well as the lead midwife will 
monitor the study process on site and remind the participants to fill in the questionnaires. 
5 
REGULATORY ASPECTS AND SAFETY 
5.1 
Local regulations / Declaration of Helsinki 
This study is conducted in compliance with the protocol, the current version of the Declaration of 
Helsinki, the ICH-GCP the HRA as well as other locally relevant legal and regulatory 
requirements.  
5.2 
(Serious) Adverse Events and notification of safety and protective measures 
An Adverse Event (AE) is any untoward medical occurrence in a patient or a clinical investigation 
subject which does not necessarily have a causal relationship with the trial procedure. An AE can 
therefore be any unfavourable or unintended finding, symptom, or disease temporally associated 
with a trial procedure, whether or not related to it. 
 
A Serious Adverse Event (SAE) (ClinO, Art. 63) is any untoward medical occurrence that 
- 
Results in death or is life-threatening, 
- 
Requires in-patient hospitalisation or prolongation of existing hospitalisation, 
- 
Results in persistent or significant disability or incapacity, or 
- 
Causes a congenital anomaly or birth defect  
 
Both Investigator and Sponsor-Investigator make a causality assessment of the event to the trial 
intervention, (see table below based on the terms given in ICH E2A guidelines). Any event 
assessed as possibly, probably or definitely related is classified as related to the trial intervention. 
 
 

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Relationship 
Description 
Definitely 
Temporal relationship 
Improvement after dechallenge* 
Recurrence after rechallenge 
(or other proof of drug cause) 
Probably 
Temporal relationship 
Improvement after dechallenge 
No other cause evident 
Possibly 
Temporal relationship 
Other cause possible 
Unlikely 
Any assessable reaction that does not fulfil the above conditions 
Not related 
Causal relationship can be ruled out 
*Improvement after dechallenge only taken into consideration, if applicable to reaction 
 
Both Investigator and Sponsor-Investigator make a severity assessment of the event as mild, 
moderate or severe. Mild means the complication is tolerable, moderate means it interferes with 
daily activities and severe means it renders daily activities impossible.  
 
Reporting of SAEs (see ClinO, Art. 63) 
All SAEs are documented and reported immediately (within a maximum of 24 hours) to the 
Sponsor-Investigator of the study. 
If it cannot be excluded that the SAE occurring in Switzerland is attributable to the intervention 
under investigation, the Investigator reports it to the Ethics Committee via BASEC within 15 days. 
 
Follow up of (Serious) Adverse Events 
Participants, who experience an (Serious) Adverse Event during childbirth will be contacted after 
terminating the study to answer questions, to ensure . If necessary, contact details of 
professionals, who could offer additional support, will be provided. 
 
Notification of safety and protective measures (see ClinO, Art 62, b) 
If immediate safety and protective measures have to be taken during the conduct of the study, 
the investigator notifies the Ethics committee of these measures, and of the circumstances 
necessitating them, within 7 days. 
5.3 
(Periodic) safety reporting 
An annual safety report (ASR) is submitted once a year to the local Ethics Committee by the 
Investigator (ClinO, Art. 43 Abs 1). 
5.4 
Radiation 
Not applicable 
5.5 
Pregnancy 
All participants will be pregnant because of the nature of the study. Reporting of pregnancies will 
therefore not be necessary. 

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5.6 
Amendments 
Substantial changes to the study setup and study organization, the protocol and relevant study 
documents are submitted to the Ethics Committee for approval before implementation. Under 
emergency circumstances, deviations from the protocol to protect the rights, safety and well-being 
of human subjects may proceed without prior approval of the Ethics Committee. Such deviations 
shall be documented and reported to the Ethics Committee as soon as possible. 
Substantial amendments are changes that affect the safety, health, rights and obligations of 
participants, changes in the protocol that affect study objective(s) or central research topic, 
changes of study site(s) or of study leader and sponsor (ClinO, Art. 29). 
A list of substantial changes is also available on www.swissethics.ch. 
A list of all non-substantial amendments will be submitted once a year to the competent EC 
together with the ASR. 
5.7 
Notification and reporting upon completion, discontinuation or interruption of the 
study 
The Sponsor-Investigator may terminate the study prematurely according to certain 
circumstances, e.g. 
- 
Ethical concerns, 
- 
Insufficient participant recruitment, 
- 
When the safety of the participants is doubtful or at risk (e.g. when the benefit-risk 
assessment is no longer positive), 
- 
Alterations in accepted clinical practice that make the continuation of the study unwise, or 
- 
Early evidence of harm or benefit of the experimental intervention 
Upon regular study completion, the Ethics Committee is notified via BASEC within 90 days (ClinO, 
Art. 38).  
 
Upon premature study termination or study interruption, the Ethics Committee is notified via 
BASEC within 15 days (ClinO, Art. 38). 
 
A final report is submitted to the Ethics Committee via BASEC within a year after completion or 
discontinuation of the study, unless a longer period is specified in the protocol (ClinO, Art. 38). 
5.8 
Insurance 
In the event of study-related damage or injuries, the liability of Zurich University of Applied 
Sciences provides compensation, except for claims that arise from misconduct or gross 
negligence. ZHAW has a liability insurance with an overall sum insured over CHF ten Mio. With 
one Mio. per participants to cover personal injuries. The study is registered correctly with Zurich 
Insurance.  
6 
FURTHER ASPECTS 
6.1 
Overall ethical considerations 
Health-related data is considered to be sensitive personal data by the Federal Act on Data 
Protection. Thus, procedures must comply with the current GCP standards and the Human 
Research Act of Switzerland. Throughout the research process, we will pay close attention to 
dynamic ethical issues. We consider general ethical issues when designing, implementing, 
and reporting our research (e.g., following publication rules). 
 

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In the study information and the consent form, the study and its purpose will be described, 
and it will be highlighted that participation is entirely voluntary and that participation can be 
refused or withdraw at any stage, with no further consequences. Furthermore, participants 
will be informed about the intended research project and all benefits and risks (principle of 
autonomy). All data will be encoded which makes it impossible to conclude on a specific data 
without the participant identification list. The participant identification list will only be accessible to 
a sub-group of the study personnel and only people with appropriate training in Good Clinical 
Practice (GCP). Data will be threated confidentially. We conclude that our research is in the 
interest of the childbearing women (principle of fairness or justice), and that the women could 
directly benefit from the antenatal education class and therefore from the research (principle 
of beneficence). In order to minimize outside influence and manipulation, we openly account 
for our purposes and methods.  
We will validate an antenatal education class including a breathing and relaxation technique. 
The planned study consists of the validation and evaluation of an antenatal education class to 
increase women`s self-confidence as well as their self-efficacy. The entire project of development, 
evaluation and implementation is thought through and elaborated with the help of the MRC 
Framework (Michie et al., 2008, 2011). 
Finally, we will seek ethical approval for the evaluation of the antenatal education class 
including a breathing and relaxation technique to increase women`s self-efficacy at the Ethics 
Committee of the Canton Zurich.  
6.2 
Risk-benefit assessment  
We do not expect any serious risks for the participants. Antenatal education is part of antenatal 
care and is financed by the obligatory health insurance (OKP). Every woman has the opportunity 
to attend an antenatal education class if she would like to. Women benefit from the information 
provided in the antenatal class as well as the exercises to support them during the labour and 
birth. However, participants will complete questionnaires during pregnancy and after birth. This 
could be an additional challenge and a lager workload for women. In addition, it is possible that 
the childbirth experience will become present through the questionnaires. This is why the 
participants are offered the opportunity to get in touch with the supervising midwife and to have a 
follow-up talk with the birth attendant midwife. If further support is indicated, it is possible to involve 
the relevant specialists at the Cantonal Hospital Winterthur. 
7 
QUALITY CONTROL AND DATA PROTECTION 
7.1 
Quality measures  
Several quality measures will be installed: 
• 
The antenatal midwives in the Canton Hospital Winterthur will be trained before the 
intervention. The investigator organises a 2-hour workshop where the course concept 
as well as the breathing and relaxation technique is discussed and practised together. 
In addition, the investigator is always available to answer questions from the midwives. 
Midwives receive a handout with the background and the breathing and relaxation 
technique. 
• 
Data will be collected using REDCap®. REDCap® is a secure web application for 
building and managing surveys as well as databases compliant to the demands of 
GCP Swiss regulations regarding clinical studies. An audit trail will document all 
changes made to the data. The audit trail contains the person that made the changes, 
the time the change was made, and the data before the change. Automated checks 
implemented in the data entry field further check the data for plausibility and 
completeness as it is saved. The software gives continuous feedback to the users as 

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how to correct the data in order to comply to defined rules. Erroneous and missing 
data are marked for follow up. 
• 
The investigator at ZHAW will be responsible for data checking and data storing using 
REDCap® correctly.  
 
For quality assurance the sponsor, the Ethics Committee or an independent trial monitor may visit 
the research sites. Direct access to the source data and all study related files is granted on such 
occasions. All involved parties keep the participant data strictly confidential.  
7.2 
Data recording and source data 
Quantitative data (questionnaire data, labour and birth data from medical records) will be 
entered by a midwife and a research assistant in the study site to the open source software 
REDCap® (Research Electronic Data Capture). REDCap® is an international commercial 
study software compliant to the demands of the current GCP standards and the Human 
Research Act of Switzerland (https://www.project-redcap.org/software/). REDCap® is a secure 
web application for building and managing surveys as well as databases compliant to the 
demands of GCP Swiss regulations regarding clinical studies. Data can be entered from any 
computer connected to the internet providing current browser software (e.g., Mozilla Firefox). 
Data entry fields in REDCap® are in a specific format that allows only entering data in this 
format (e.g., date fields, number fields). An audit trail will document all changes made to the 
data. The audit trail contains the person that made the changes, the time the change was 
made, and the data before the change. Automated checks implemented in the data entry field 
further check the data for plausibility and completeness as it is saved. The software gives 
continuous feedback to the users as how to correct the data in order to comply to defined 
rules. Erroneous and missing data are marked for follow up. The database will contain a CRF 
for each participant with a unique study ID and the year of birth. It will not contain any further 
personal data such as name or birth date.  
 
We plan to provide a protocol with detailed descriptions on how the data was recorded. The 
metadata will include details about the date and time of data collection, data processing 
methods, analytical steps, units of measurements, and identifier on the person performing 
processing steps. This information will be stored in a README-file for each dataset. 
7.3 
Confidentiality and coding 
Trial and participant data will be handled with uttermost discretion and is only accessible to 
authorised personnel who require the data to fulfil their duties within the scope of the study. On 
the CRFs and other study specific documents, participants are only identified by a unique 
participant number. The participant identification list will be stored on a separate secured pool on 
the server of ZHAW. All data will be encoded which makes it impossible to conclude on a specific 
data without the participant identification list. The participant identification list will only be 
accessible to a sub-group of the study personnel and only people with appropriate training in 
Good Clinical Practice (GCP). 
 
The participant identification list is stored in the study centre in password protected pool or closed 
locker.  
Only non-genetic data is used.  
 
Biological material: not applicable 
 
 

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7.4 
Retention and destruction of study data and biological material 
All data will be stored for a minimum of ten years on restricted servers at ZHAW and made 
available under the respective terms of usage upon request.  
8 
MONITORING AND REGISTRATION 
A researcher from ZHAW with a GCP course, who is not involved in the project, will conduct the 
monitoring visits. Monitoring visits are planned twice during the one-year data collection period. 
During these visits, data entry of labour and birth data will be checked. A total of 10% of labour 
and birth data, including those of the first recruited woman will be checked comparing with medical 
records. If error rates are above 5%, all labour and birth data of this site needs to be checked. 
The study sites will make source data/documents accessible to the monitors and questions are 
answered during monitoring.  
The study will be registered in the International Clinical Trials Registry Platform (ICTRP). 
Additionally, it is registered in the Swiss National Clinical Trial Portal (SNCTP) via BASEC with 
the Ethical proposal. 
9 
FUNDING / PUBLICATION / DECLARATION OF INTEREST 
The study is part of a PhD project and is therefore supported by both the Zurich University of 
Applied Science and the University of Zurich.  
The study is funded by the Amaari Foundation. The Contract was signed with the Canton Hospital 
Winterthur which regulate the collaboration, the rights regarding the data and the publication 
policy of the study. Results of the study will be published in international peer-reviewed scientific 
journals as well as in professional journals and will be presented at national and international 
conferences. We will follow the recommendation of the Academies of Sciences and Humanities 
Switzerland. 
 
 

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Vanderlaan, J., Gatlin, T., & Shen, J. (2022). Outcomes of Childbirth Education in PRAMS, Phase 
8. Maternal and Child Health Journal. https://doi.org/10.1007/s10995-022-03494-3 
Yohai, D., Alharar, D., Cohen, R., Kaltian, Z., Aricha-Tamir, B., Aion, S. B., Yohai, Z., & Weintraub, 
A. Y. (2018). The effect of attending a prenatal childbirth preparedness course on labor duration 
and outcomes. Journal of Perinatal Medicine, 46(1), 47–52. https://doi.org/10.1515/jpm-2016-
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Appendix 1: Schedule of assessments  
 
Time (hour, 
day, week) 
>-1 day 
> 12 weeks of 
gestation 
2nd trimester 
After 
intervention 
(~36 weeks 
gestation) 
Birth 
records 
Postnatal (4 
to 8 weeks 
after birth) 
Visit/Activity 
Information 
(visit or 
telephone) 
Screening 
(face-to-face 
or mail post) 
Baseline 
online 
survey 
Intervention 
online survey 
Maternal 
and 
neonatal 
brith data 
Postnatal 
online 
survey 
Oral and 
written patient 
information 
+ 
 
 
 
 
 
Written 
consent 
 
+ 
 
 
 
 
Inclusion-/ 
exclusion 
criteria 
+ 
+ 
 
 
 
 
Medical history 
 
 
+ 
 
+ 
 
Physical 
examination 
 
 
 
 
 
 
Participant 
characteristics 
 
 
+ 
 
+ 
 
Intervention 
 
 
 
 
+ 
 
Questionnaire 
 
 
+ 
 
+ 
+ 
Sampling 
 
 
 
 
 
 
Safety 
 
+ 
 
 
+