Condition category
Pregnancy and Childbirth
Date applied
30/08/2019
Date assigned
03/09/2019
Last edited
06/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background
Miscarriage is common, but the emotional effects often go unrecognised and unsupported. Men are also presupposed to be emotionally less affected than women because they do not experience the biological effects of miscarriage, and because many people consider masculinity to mean absence of emotion. However many men describe feelings of disorientation and fear during and after miscarriage. Men who experience multiple miscarriages may also find grief and anxiety intensified by loss of hope for any healthy pregnancy in the future.

Study aims
Studies of the experiences of men who have lived through multiple miscarriages are limited. Therefore we aim to explore and better understand the experiences and any support requirements of men with a history of repeated pregnancy loss.

Who can participate?
We will interview men with a history of two or more miscarriages, to listen and learn about these experiences. The participants will be invited by healthcare practitioners at a large urban hospital with a recurrent miscarriage clinic, and by advertisements to be disseminated by miscarriage charities, in the United Kingdom.

What does the study involve?
Between 30 and 50 semi-structured telephone interviews with consented individuals will be audio-recorded, transcribed into written form and anonymised prior to analysis. Then the interpretations of the research team will be presented to the study participants, to enable them to clarify or correct these findings.

What are the possible benefits and risks of participating?
Contribution to this study will enable men living through multiple miscarriages to talk about their experiences, and to communicate their thoughts and feelings to an interested, non-judgemental listener. We also hope for the study findings to influence policy and practice in the management of multiple miscarriages.

Many people value the opportunity to be heard, but our subject matter is potentially emotive. If participants experience any distress then it will be possible for them to take a break or discontinue participation completely. Psychosocial support will be signposted in participant information literature and in other communications as necessary. The investigative team will be continuously vigilant to ongoing consent, and indications of emotional distress will be managed via a pathway developed in previous studies to ensure appropriate empathy.

Although contribution to the study will take up some time for interview and focus group discussion, every effort will be made to suit the convenience of participants. We will be happy to interview in the morning, afternoon or evening, and any day of the week. Men will also receive a £20 honorarium (digital high street voucher) as a token of appreciation for the time and effort contributed.

Where is the study run from?
Birmingham Women’s and Children’s Hospital, UK

When is the study starting and how long is it expected to run for?
October 2019 to June 2022

Who is funding the study?
Tommy's, UK

Who is the main contact?
Helen Williams
hmw471@student.bham.ac.uk

Trial website

https://www.birmingham.ac.uk/research/activity/mds/centres/maternal-health/research/experiences.aspx

Contact information

Type

Public

Primary contact

Miss Helen Williams

ORCID ID

http://orcid.org/0000-0003-4417-9404

Contact details

University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44(0)121 414 8504
hmw471@student.bham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

University of Birmingham ERN 16-0123, REC 16/WM/0423

Study information

Scientific title

Men Living Through Multiple Miscarriages: A Qualitative Exploration of Experiences and Support Requirements

Acronym

Study hypothesis

What are the experiences and any support requirements of men living through multiple miscarriages?

Ethics approval

Approved 27/08/2019, West Midlands South Birmingham Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44207 104 8108; NRESCommittee.westmidlands-southbirmingham@nhs.net), ref: 16/WM/0423

Study design

Qualitative study

Primary study design

Other

Secondary study design

Trial setting

Home

Trial type

Other

Patient information sheet

https://www.birmingham.ac.uk/Documents/college-mds/research/Men-Living-Through-Multiple-Miscarriages-Participant-Information-Leaflet-Version-2.0.pdf

Condition

Multiple (two or more) miscarriages before 16 weeks of gestation

Intervention

Our qualitative study design is underpinned by the sounds of silence framework previously developed by Serrant-Green: primary data will be collected via semi-structured telephone interviews and interpreted via the framework method (Ritchie and Lewis) with a focus group discussion to enable member synthesis.

Men will be invited to participate in the study by healthcare practitioners at a large urban hospital with a recurrent miscarriage clinic, and by advertisements to be disseminated by miscarriage charities, in the United Kingdom.

Work Package 1
Informed by the sounds of silence framework, semi-structured telephone interviews will enable participants to communicate their experiences of multiple miscarriages freely enough to yield rich textual data, but without undue diversion to issues beyond the scope of our study objectives. Natural dialogue will be supported by a discussion guide with appropriate prompts where required. The interviews are anticipated to last up to 60 minutes each. They will be digitally audio-recorded and transcribed verbatim. The study team will review each transcription to ensure accuracy and to anonymise any personally identifiable data prior to analysis.

Work Package 2
Different voices and silences are audible to different people, so we will adopt the principles of member synthesis to enable the sample population to clarify and elaborate or reconstruct our preliminary interpretations of interview data. A face-to-face focus group discussion of up to 120 minutes will be arranged and facilitated to encourage constructive contributions from everybody. The dialogue will be digitally audio-recorded and transcribed verbatim. The study team will review the transcription to ensure accuracy and to anonymise any personally identifiable data prior to further analysis.

Intervention type

Other

Phase

Drug names

Primary outcome measure

We will generate evidence of the experiences and any support requirements of men living through multiple miscarriages. Qualitative study data will be collected as audio-recordings of semi-structured telephone interviews (each 60 minutes) and then a focus group discussion (120 minutes), alongside reflexive journal entries of the researchers throughout the lifetime of the study. They will be supplemented by demographic information to be collected in a proforma questionnaire to facilitate maximum variation among the recruited sample and to contextualise any findings.

Data collection and analysis within the scope of Work Package 1 will continue concurrently until saturation is sufficient to provisionally satisfy our study objectives. However, we anticipate all data collection to be complete with approximately 24 months.

Secondary outcome measures

N/A

Overall trial start date

01/07/2019

Overall trial end date

30/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male
2. Aged 18 years or more
3. Experience of two or more clinically confirmed pregnancies that both ended spontaneously before 16 completed weeks of gestation
4. Able to hold a conversation in English
5. Able and willing to give informed consent to participate in an audio-recorded telephone interview

Participant type

Mixed

Age group

Adult

Gender

Male

Target number of participants

30 - 50

Participant exclusion criteria

1. More than 12 months since most recent miscarriage (to ensure relevance to current clinical practice)
2. Infertility diagnosis (to eliminate confusion with experiences of infertility)

Recruitment start date

01/10/2019

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women’s and Children’s Hospital
Mindelsohn Way
Birmingham
B15 2TG
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Research Governance and Integrity
Research Support Group
Room 119 Aston Webb Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0) 121 415 8011
researchgovernance@contacts.bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Tommy's

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Study findings will be owned by the University of Birmingham and disseminated with a focus on the experiences and any support requirements of men living through multiple miscarriages. They may also be used to inform the development of future funding proposals, and to facilitate the continuous professional development of healthcare practitioners at Birmingham Women’s and Children’s Hospital or beyond, via presentation and discussion at clinical team meetings or conferences.

1. Information about the rationale, aims and methods of the study will be available from webpages of the University of Birmingham throughout the lifetime of the project
2. Study findings will be reported in the form of a doctoral research thesis and academic manuscripts, to be supplemented by presentations at relevant conferences. The manuscripts will be also made openly available via a dedicated online repository hosted by the University of Birmingham for this purpose
3. In order to ensure the study findings gain maximum impact beyond the academic community, researchers will liaise with dedicated professional services such as press and communications teams at the University of Birmingham, to bring male experiences of multiple miscarriages to the attention of a wider audience
4. Media engagement will be further supported by the Communications Director of Birmingham Women’s and Children’s Hospital, and by the Marketing and Communications Manager of Tommy’s
5. Public impact will be promoted by proactive engagement of the research team with local lay forums such as the Family and Patient Advisory Council of Birmingham Women’s and Children’s Hospital, and with national miscarriage charities such as Tommy’s and the Miscarriage Association

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available from the corresponding author on reasonable request.

The final study dataset will comprise consent forms, demographic questionnaires, audio-recordings and transcripts of data collection events, and field notes. These data will be accessible only to the research team, the Sponsor and relevant regulatory authorities. However, the research team will make the findings of the study freely available through publication or other dissemination tools without any unnecessary delay. The findings will be accompanied by an honest, accurate and transparent account of the study methods.

Permission for anonymised data to be shared for the purpose of future academic research will be sought from all participants prior to any data collection. Then for ten years after first publication of the findings, the research team will consider external requests to obtain anonymised study data only, to be securely shared under the auspices of the Chief Investigator [Professor Arri Coomarasamy: a.coomarasamy@bham.ac.uk]. All requesters wishing to obtain any part of the dataset will be asked to provide a brief research proposal to summarise objectives and timelines of the candidate project, intellectual property rights, and expectations for publications and citations. These details will form the basis of a Data Sharing Agreement between the University of Birmingham and the requester, to clearly establish the responsibilities of each party. It is expected that requesters will, as a minimum, acknowledge the original research team and Tommy’s funding for the study, and will consider co-authorship of any subsequent publications, if appropriate.

Intention to publish date

30/06/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/09/2019: Internal review. 02/09/2019: Trial’s existence confirmed by West Midlands South Birmingham Research Ethics Committee