An Exploration of Mother's Experiences of Antenatal Hand Expression of Colostrum, and the Effects Upon Breastfeeding Continuation and Maternal Emotional Health.
Conditions: Feeding; Difficult, Newborn
Sponsor: University of Liverpool

 
 
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An Exploration of Mother’s Experiences of Antenatal Hand Expression of 
Colostrum, and the Effects upon Breastfeeding Continuation and Maternal 
Emotional Health. 
Version 1 June 2018 
Main Sponsor: University of Liverpool 
 
Study Team 
Chief Investigator: Dr Vicky Fallon 
Co‐investigators: Sophie Ellerington and Dr Joanne Harrold 
 
 

 
 
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Study Coordination 
For general queries, supply of Study documentation, and collection of data, please contact:  
Study Coordinator: Dr Vicky Fallon 
School of Psychology, Eleanor Rathbone Building 
Bedford Street South, L69 7ZA 
Tel: 0151 794 1402 
Email: vfallon@liv.ac.uk 
Clinical Queries 
Clinical queries should be directed to Carol Murray (Infant Feeding Coordinator at Liverpool Women’s Hospital) 
at carol.murray2@lwh.nhs.uk who will direct the query to the appropriate person. 
Sponsor 
The University of Liverpool is the research Sponsor for this Study. For further information regarding the 
sponsorship conditions, please contact: 
Alex Astor 
Head of Research Support – Health and Life Sciences 
University of Liverpool 
Research Support Office 
2nd Floor Block D Waterhouse Building 
3 Brownlow Street 
Liverpool L69 3GL 
sponsor@liv.ac.uk mailto:Astor@liv.ac.uk  
Funder 
University of Liverpool, School of Psychology 
 
 

 
 
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STUDY SUMMARY 
This protocol describes the Exploration of Antenatal Hand Expression Study and provides information about 
procedures for entering participants. Every care was taken in its drafting, but corrections or amendments 
may be necessary. These will be circulated to investigators in the Study. Problems relating to this Study should 
be referred, in the first instance, to the Chief Investigator. 
This study will adhere to the principles outlined in the UK Policy Framework for Health and Social Care Research 
(v3.2 10th October 2017). It will be conducted in compliance with the protocol, the Data Protection Act and 
other regulatory requirements as appropriate. 
 
TITLE: An Exploration of Mother’s Experiences of Antenatal Hand Expression of Colostrum, and the Effects 
upon Breastfeeding Continuation and Maternal Emotional Health. (An Exploration of Antenatal Hand 
Expression.) 
DESIGN: Qualitative research 
AIMS: To explore how antenatal hand expression of colostrum impacts on breastfeeding continuation and on 
maternal emotional health. Women’s experiences of antenatal hand expression will be explored during semi-
structured interviews and analysed using modified grounded theory analysis. 
POPULATION ELIGIBILITY: Women over the age of 18; Women who have experience of antenatal hand 
expression within the last three months; Women with a good grasp of the English Language; Women with no 
clinical mental health diagnosis; Women of infants born >37 weeks gestation.  
DURATION: September 2018- May 2019 
 
 
 

 
 
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Table of Contents 
1. INTRODUCTION 
6 
1.1 BACKGROUND 
6 
2. STUDY OBJECTIVES 
7 
3. STUDY DESIGN 
7 
3.1 STUDY OUTCOME MEASURES 
7 
4. PARTICIPANT ENTRY 
7 
4.1 PRE‐REGISTRATION EVALUATIONS 
7 
4.2 INCLUSION CRITERIA 
8 
4.3 EXCLUSION CRITERIA 
8 
4.4 WITHDRAWAL CRITERIA 
8 
5. ADVERSE EVENTS 
8 
5.1 DEFINITIONS 
8 
5.2 REPORTING PROCEDURES 
8 
 
 
6. STATISTICS AND DATA ANALYSIS 
9 
7. REGULATORY ISSUES 
9 
7.1 ETHICS APPROVAL 
9 
7.2 CONSENT 
10 
7.3 CONFIDENTIALITY 
10 
7.4 INDEMNITY 
10 
7.5 SPONSOR 
10 
7.6 FUNDING 
10 

 
 
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7.7 AUDITS AND INSPECTIONS 
10 
8. STUDY MANAGEMENT 
11 
9. END OF STUDY 
11 
10. ARCHIVING 
11 
11. PUBLICATION POLICY 
11 
12. REFERENCES 
11 
 
 
 
 

 
 
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1. INTRODUCTION 
1.1 BACKGROUND 
This study aims to explore mother’s experiences of antenatal hand expression of colostrum and its impact upon 
breastfeeding continuation and maternal emotional health. Antenatal hand expression was initially used with 
diabetic women during the final weeks of pregnancy to collect colostrum prior to their baby’s birth. Babies of 
diabetic mothers sometimes require supplementary feeds during the first few days after birth to maintain 
blood sugar levels. In order to reduce the need to rely on formula for these supplementary feeds this practice 
was developed to build up a store of colostrum. The DAME (Diabetes and Antenatal Milk Expressing) Trial found 
that babies of mothers who hand expressed colostrum during late pregnancy were less likely to receive formula 
in the first 24 hours of life (Forster et al, 2017). 
Due to its efficacy, this intervention was extended at Liverpool Women’s Hospital to include all pregnant 
women. During antenatal classes, women are taught how to hand express and are given syringes to collect 
their colostrum and store in a freezer. Health care professionals have anecdotally found this practice to be 
reassuring to women at Liverpool Women’s Hospital, however there has been no research examining the 
experiences of the women themselves. It is thought that antenatal hand expression increases confidence with 
breastfeeding and supports women to establish breastfeeding. This study will help identify the effects of 
antenatal hand expression on breastfeeding continuation and on maternal emotional health.  
The aim is to recruit 12 women over the age of 18 through Liverpool Women’s Hospital who have recent 
experience of this practice. The study has the support of the Infant Feeding Coordinator at the hospital who will 
identify participants and provide them with information about the study. The study will involve conducting a 
semi-structured interview which will assess participant’s views and experiences of antenatal hand expression. 
These interviews can be conducted at the participant’s homes, at the University of Liverpool Infant Feeding 
Laboratory or via telephone or Skype, as specified as the most convenient by the participant. Interviews will be 
digitally recorded and transcribed by the student researcher, and a Grounded Theory Analysis will be used to 
analyse the data. It is anticipated that the views and experiences of these women will aid future planning of 
maternity care services at Liverpool Women’s Hospital and, if beneficial, the intervention may be extended to 
other trusts.  
1.2 RATIONALE FOR CURRENT STUDY 
To explore how antenatal hand expression impacts of colostrum on breastfeeding continuation and on 
maternal emotional health. Breastfeeding offers numerous health benefits to both mother and infant (Victoria 
et al, 2016) and initiation of breastfeeding within an hour of birth is a key recommendation made by the World 
Health Organisation (WHO, 2017) to avoid early supplementation with formula. Given low breastfeeding rates, 
particularly in Liverpool, and barriers to breastfeeding which some women experience, this can be difficult to 
achieve. Preparing colostrum in advance of the birth helps to avoid early supplementation with formula and 
has been successfully used at Liverpool Women’s Hospital to ensure that infants receive breastmilk after birth. 
The impact of this strategy has not been explored. 

 
 
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2. STUDY OBJECTIVES 
The primary objective is to explore mother’s experiences of antenatal hand expression of colostrum during the 
late stages of pregnancy, including any difficulties or benefits and the mother’s perception of this experience. 
The secondary objective is to explore the impact of antenatal hand expression on breastfeeding continuation 
and maternal emotional health. Other study objectives include; identifying if any further support could be given 
to women hand expressing antenatally, to promote recommended feeding practices and to support their 
emotional health, and; exploring whether antenatal hand expression builds breastfeeding confidence.   
3. STUDY DESIGN 
The study will use a qualitative design. The study will recruit 12 women who have experience of antenatal hand 
expression within the last three months, through an Infant Feeding Coordinator based at Liverpool Women’s 
Hospital, with whom the Chief Investigator has strong links. The research team has a history of successfully 
implementing similar qualitative infant feeding studies. Semi-structured interviews will be carried out by the 
student researcher (accompanied by a member of the staff team) to stimulate thorough responses from the 
participants on their experience of antenatal hand expressing. Interviews will take place wherever it is easiest 
for the participant, either in their home, in the School of Psychology’s Infant Feeding Laboratory or via 
Skype/phone call. Participants choosing to travel to the University will be reimbursed for travel expenses 
incurred. Interviews will be digitally recorded with permission from the participant and the student researcher 
will transcribe and analyse the data using a Grounded Theory Analysis.  
3.1 STUDY OUTCOME MEASURES 
The aim of this this study is to investigate mothers’ experiences of antenatal hand expression of colostrum, the 
effects on maternal emotional state and the impact upon the continuation of breastfeeding, which has not 
previously been explored. It is hoped that this research will provide a better understanding of the experiences 
of mothers who have needed to hand express while pregnant, in order to identify how women can best be 
supported during this time, during the early weeks of motherhood, and in establishing breastfeeding. 
 
4. PARTICIPANT ENTRY 
4.1 PRE‐REGISTRATION EVALUATIONS 
The Infant Feeding Coordinator at Liverpool Women’s Hospital will provide information to potential 
participants about the study and those who express interest in taking part will receive the research team’s 
contact information. Upon contact with the research team, screening questions will be asked via phone or 
email to verify that the potential participant fulfils the inclusion criteria. Potential participants will then be sent 
information on the study and a provisional appointment made for informed consent and the interview. 
Participants will be made aware that they cannot take part in the interview unless informed consent has been 
given. There will be a 48-hour cooling-off period between the provision of the information sheet and the 

 
 
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process of informed consent, to give the participants time to read and digest the information. Participants who 
are being interviewed via Skype or telephone will be emailed the participant information sheet and consent 
form, and must sign and return prior to an interview being scheduled.  
4.2 INCLUSION CRITERIA 
Women over the age of 18 who have experience of antenatal hand expression within the last three months, 
and are available to take part in an interview about their experiences. Women must have a good grasp of the 
English Language, to ensure understanding, as the research team is monolingual.  
4.3 EXCLUSION CRITERIA 
Women with a diagnosed mental health condition and mothers of preterm babies (< 37 weeks), as these 
factors may confound experiences. 
4.4 WITHDRAWAL CRITERIA 
Participants will be made aware from the first contact with the research team, and throughout the process, 
that they are able to withdraw from the study at any time, without explanation and without their rights being 
affected in any way. In the event that a participant becomes distressed during interview, the interview and 
recording will be suspended immediately, and the participant accompanied to comfortable location to recover. 
Participants being interviewed on Skype or phone will be offered immediate support on the line. The 
participant and researcher will collaboratively decide whether to end the interview and for the participant to 
withdraw from the study. 
5. ADVERSE EVENTS 
5.1 DEFINITIONS 
The risk of adverse events in this study involving interviews is very low. 
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject. 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect that: 
• 
Results in death 
• 
Is life‐threatening – refers to an event in which the subject was at risk of death at the time of the 
event; it does not refer to an event which hypothetically might have caused death if it were more severe 
• 
Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
5.2 REPORTING PROCEDURES 
All adverse events will be reported directly to the Chief Investigator. 

 
 
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5.2.1 Non serious AEs 
No serious adverse events are expected; however, some mothers may feel upset by some of the topics 
discussed. The information sheet outlines research activities, ensuring participants are aware of the materials 
and activities involved in the study (for example interview questions about birth experience or negative infant 
feeding experiences) and are able to make an informed decision about participation. A distress protocol has 
been devised to manage distress in the event of this occurring and the Chief Investigator is well trained in 
managing participant distress. In the event that a participant becomes distressed during interview, the interview 
and recording will be suspended immediately, and support offered. Participants being interviewed in person will 
be accompanied to a comfortable location and given a period of time to recover, whilst those on Skype or phone 
interviews will be supported over the line. The interviewer and participant will collaboratively decide upon their 
ability to continue the interview following this period.  
On completion of the study or on withdrawal, participants will receive a full debrief, including sources of 
postpartum well-being support and the researchers contact information. Participants will not receive any 
specific advice on postpartum mental health directly from the researchers but will be directed to relevant 
websites and sources of information. Those who have experienced distress will be encouraged to contact their 
GP, if necessary. Alternatively, with participant consent, the researcher will carry this out for them, or contact a 
family member of friend if they wish. A courtesy call will be made (if the participant consents) in the following 
days, to ensure the participant is no longer distressed. 
5.2.2 Serious AEs 
An SAE form will be completed and emailed to the Chief Investigator within 24 hours. The Chief Investigator 
will notify the Sponsor of all SAEs. 
 
6. STATISTICS AND DATA ANALYSIS 
The sample size is small as the study's focus is on qualitative methods. We aim to recruit 12 eligible participants 
to interview, with research showing that data saturation can be achieved with these numbers (Guest, Bunce & 
Johnson, 2006). Participants will be recruited via purposive sampling, interviews transcribed, and data analysed 
using a Grounded Theory Method. 
7. REGULATORY ISSUES 
7.1 ETHICS APPROVAL 
The Chief Investigator has obtained approval from the Research Ethics Committee and Health Research 
Authority (HRA) approval. The study will be submitted to each proposed research site for Confirmation of 
Capacity and Capability. The study will be conducted in accordance with the recommendations for physicians 
involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later 
revisions. 

 
 
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7.2 CONSENT 
Following expressions of interest, the researchers will verify that participants fulfil the inclusion criteria. 
Participants will be sent information on the study and a provisional appointment for informed consent and the 
interview. Participants will be made aware that they cannot take part in the interview unless informed consent 
has been given and that they are free to withdraw at any time, without giving reason. There will be a 48-hour 
cooling-off period between provision of the information sheet and the process of informed consent, to allow 
participants time to read and digest the information. Participants who are being interviewed via Skype or phone 
will be emailed the participation information sheet and consent form and must sign and return to the research 
team prior to an interview being scheduled. 
7.3 CONFIDENTIALITY 
The Chief Investigator will preserve the confidentiality of participants taking part in the study and will 
abide by the Data Protection Act. 
Confidentiality will be ensured in accordance with the University of Liverpool information security policy. The 
Chief Investigator has been trained in the security of information appropriately. Confidentiality and anonymity 
will be maintained throughout the study and it will not be possible to identify the participant in any 
publications. To ensure anonymity of personal data, participants will be allocated pseudonyms which will be 
assigned before each recorded interview commences. During the transcription process, pseudonyms will be 
used to replace the names of any friends, family and health professionals mentioned in interviews by 
participants. Only researchers named on this application will have access to the audio files. 
7.4 INDEMNITY 
The University of Liverpool holds Indemnity and insurance cover with Marsh UK LTD, which apply to this study. 
7.5 SPONSOR 
The University of Liverpool will act as Sponsor for this study. It is recognised that as an employee of the 
University the Chief Investigator has been delegated specific duties, as detailed in the Sponsorship Approval 
letter. 
7.6 FUNDING 
The School of Psychology will be funding this study as it will be conducted as part of an Undergraduate third 
year project. Participants will receive a £5 voucher on completion of their interview and will be reimbursed for 
any travel expenses.  
7.7 AUDITS 
The study may be subject to inspection and audit by the University of Liverpool under their remit as sponsor 
and other regulatory bodies to ensure adherence to GCP and the UK Policy Framework for Health and Social 
Care Research (v3.2 10th October 2017). 

 
 
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8. STUDY MANAGEMENT 
The day‐to‐day management of the study will be coordinated by Dr Vicky Fallon. 
9. END OF STUDY 
The study will end when the final study report is written 
10. ARCHIVING 
With permission from the participant, the interview will be digitally recorded using a Dictaphone and save as 
an audio file. Audio files will be kept on a secure University drive until publication, when it will be deleted, as 
transcripts will be kept. All transcribed data will be stored electronically on a secure University drive and kept 
for 10 years. This is in accordance with the University’s data archiving procedures.  
Documents including consent forms will be stored in a locked filing cabinet in the Chief Investigator’s office 
and kept for 10 years. This is in accordance with the University’s data archiving procedures.  
11. PUBLICATION POLICY 
Publication of study findings in the Maternal and Child Nutrition Journal will be pursued.  
12. REFERENCES 
Forster, D.A., Moorhead, A.M., Jacobs, S.E., Davis, P.G., Walker, S.P., McEgan, K.M., Opie, G.F., Donath, S.M., 
Gold, L., McNamara, C., Aylward, A., East, C., Ford, R., & Amir, L.H. (2017). Advising women with diabetes 
in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a 
multicentre, unblinded, randomised controlled trial. Lancet, 389, 2204-13. 
Guest, G., Bunce, A., & Johnson, L. (2006). How many interviews are enough? an experiment with data 
saturation and variability. Field Methods, 18(1), 59-82.  
Victoria, C.G., Bahl, R., Barros, A.J.D., Franca, G.V.A., Horton, S., Krasevec, J., Murch, S., Sankar, M.J., Walker, 
N., & Rollins, N.C. (2016). Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong 
effect. Lancet, 387, 475-90. 
WHO (2017). Guideline: protecting, promoting and supporting breastfeeding in facilities providing maternity 
and newborn services. Geneva: World Health Organization. Retrieved from 
http://www.who.int/nutrition/publications/guidelines/breastfeeding-facilities-maternity-newborn/en/