Understanding delayed access to antenatal care: a qualitative study Rosalind Haddrill

4.2.2 Project management, research governance and ethical approval

The study was conceived by Dr Georgina Jones at the University of Sheffield. The study documents can be found in appendix 4. A small pilot study was undertaken in Sheffield by Dr Jones, as principal investigator, and Mr Dilly Anumba, consultant obstetrician, in April 2005, to ascertain pregnant women’s opinions about the proposed study. The majority of women were supportive of the study’s aims and willing to participate. The organisation of the project followed recognised research governance procedures and is illustrated by the research project flowchart from the study’s sponsors, STH (appendix 4.6). An application for funding for the study was made to Sheffield Health and Social Care Research Consortium (SHSCRC) by Dr Jones, Mr Anumba and Dr Caroline Mitchell, also in April 2005. Funding was awarded by SHSCRC in July 2005, and a favourable scientific review of the proposal was also given by SHSCRC at this time. Ethical approval was sought for the study by Drs Jones and Mitchell and Mr Anumba, in October 2005. The NHS Central Office for Research Ethics Committees (COREC) application form was submitted along with the study protocol and all relevant study documents, including details of the investigators, interview schedules, participant information sheets and consent forms, to North Sheffield Local Research Ethics Committee. Following minor revisions to participant information and consent forms, particularly in relation to the recruitment of teenagers, it was approved in December 2005; further minor revisions were approved in June 2007. Research governance approval for the study was given by STH in January 2006, and by SHSCRC in March 2006.
The content of the study documents reflect the ethical principles underlying The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (WMA 1964 and subsequent amendments) and the DoH’s Research Governance Framework for Health and Social Care (2005). The latter brings together general principles of good research practice and promotes a “quality research culture” (p15), through the consideration of five key areas in relation to the conduct, monitoring and assessment of research. These are

Ethics: ensuring the dignity, rights, safety and well-being of participants are protected. Detailed clarification of the ethical approach to all aspects of the study and the ethical approval process were included.

Science: ensuring a useful contribution can be made by the research and independent reviews of quality are undertaken. Details of the justification for the research and the independent scientific review were provided.

Information: ensuring free access to information and findings, and critical review through accepted channels. Proposals for dissemination of the research findings, locally and more widely through presentations at conferences and publication, were provided.

Health and safety: particularly priority to the safety of all research participants, and observation of health and safety regulations. Consideration was given to the safety and wellbeing of all the participants during the study.

Finance: particularly financial probity and compliance with the law, and provision for compensation if any harm caused. Full transparency of the financial aspects of the study and compensation provision was provided.

As part of research governance procedures a site file, using a template provided by STH, was established and maintained by Dr Jones throughout the project. The file contained essential study documents which permitted the evaluation of the conduct of the study and demonstrated the compliance of the investigator and the research team with standards for Good Clinical Practice in research (e.g. MRC 1998, 2012) and the DoH Research Governance Framework (2005). The file was available for audit as part of the research governance process, to confirm validity of the trial conduct, and contained documents relating to the study, including:

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  The study protocol
  
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  Evidence of independent scientific review
  
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  Ethics committee approval
  
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  Project registration
  
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  Financial and project management
  
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  Details of the research team
  
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  Study related literature and documents, including those relating to participants: consent forms, records of interviews, all interview schedules and data collection information (including superseded versions)
  
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  All correspondence relating to the study
  
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  Confirmation of research governance compliance (STH 2004).
  

Detailed ethical considerations in relation to the study participants are discussed later in the chapter.

4.3 The study methods

The study is illustrated in figure 4.3.1, although this provides a somewhat simplified and linear view of what was a more complex process, which is detailed in the following sections.

4.3.1 Sampling

Women were recruited to the study using a combination of purposive and theoretical sampling methods, to obtain a wide range of participants. The approach reflects the research question “what perceptions and beliefs do late booking women express about the delayed initiation of antenatal care?” and the overall goal of the research: to develop a better understanding of late booking (Bryman 2008). Initially, purposive

Figure 4.3.1: flow chart for the study

Purposive sample of late booking women approached to participate in the study. Women approached to participate at the time of attendance for first hospital antenatal booking visit, following confirmation of gestation by ultrasound scan.

Women informed of the study by midwifery or medical staff or the research midwife. Any woman interested in participating was given an information sheet to read about the study and signed a consent form agreeing to be telephoned in the first instance by the research midwife. All women were given a minimum of 48 hours prior to further contact.

Once telephoned, if they were happy to participate and be interviewed, written consent asked for, face to face, before the start of interview.

Individual, in-depth semi-structured interviews carried out and tape-recorded at the Jessop Wing, or at home or local children’s centre, at the woman’s convenience. Demographic data collected prior to interview.

Interviews continued until data saturation reached.

Qualitative analysis undertaken using a thematic approach.
Tape-recorded interviews transcribed verbatim and entered into NVIVO software. Independent verification of data. Data analysis commenced.


Theoretical sampling methods used to identify particular groups of women most likely to book late.

Broad sampling frame developed for initial purposive sampling of late booking women.


Potential participants identified through community midwife and GP referrals and co-ordination with specialist midwifery teams. Late booking defined as > 19 completed weeks gestation at first hospital appointment.





Development of taxonomy and thematic narratives. Findings written up.


Multidisciplinary analysis meetings for interpretive challenge

sampling was undertaken using decisions made prior to recruitment commencing, following an initial consideration of previous research and clinical guidance. Inclusion

and exclusion criteria were developed to create a sampling frame of all the women who might be sampled for the project, which is presented in table 4.3.2. Initial sampling was deliberately broad, to try to gain access to as wide a range of individuals relevant to the research question as possible, to obtain many different experiences of and perspectives on late booking. The inclusion criteria reflect widely accepted definitions of late booking but also essential ethical considerations such as informed consent and non-maleficence, which are considered in more detail later in the chapter. As previously discussed, the sample size was not fixed, however an initial sample of 25 women was suggested as appropriate for the study. Because audits of the 7000 women giving birth annually at the Jessop Wing demonstrated that at least 5% of women initiated antenatal care after 19 weeks gestation (NHS Sheffield 2010), it was anticipated that recruiting such a sample would be achievable.
Table 4.3.2: sampling frame for initial purposive sampling of the women

Inclusion criteria	Exclusion criteria
Pregnant women who had their first antenatal (booking) appointment at the Jessop Wing after 19 completed weeks gestation, as confirmed by ultrasound (dating) scan.	Pregnant women having their first appointment prior to 19 completed weeks gestation.
Women able to understand the project fully and give written informed consent to participate.	Women unable to understand the project fully and/or give written informed consent.
Women who had not received antenatal care elsewhere prior to this appointment, other than the initial referral appointment with their community midwife or GP.	Women who had received antenatal care elsewhere prior to their first appointment at the Jessop Wing.
Women with medically uncomplicated pregnancies.	Women where fetal abnormality had been diagnosed.

More focused sampling methods were used alongside the purposive methods to identify women from these groups, developing and refining emerging ideas which in turn influenced further recruitment. This was an ongoing process throughout the research, developed through discussion with the supervisory panel and other members of the research team. Theories from existing studies, from this discussion and from initial interviews with women, were used to make predictions about women who were more likely to book late for antenatal care and their reasons for doing so. This included women who were potentially more vulnerable and hard to reach, including:

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  Teenagers and young women
  
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  Women with learning difficulties
  
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  Women who were substance misusing
  
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  Women who experienced homelessness or changing home circumstances during their pregnancies
  

This targeted approach to sampling, achieved in part with the support of specialist midwifery teams, also aimed to address difficulties with the purposive method and overcome the apparent reluctance of particular groups of women to participate in the study.