Interactional practices of decision making during childbirth in maternity units
| ISRCTN | ISRCTN16227678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16227678 |
| IRAS number | 211358 |
| Secondary identifying numbers | 14/70/73, CPMS 32505, IRAS 211358 |
- Submission date
- 16/01/2018
- Registration date
- 13/02/2018
- Last edited
- 17/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Government policy states that women in labour should be involved in decisions about their care and treatment. It is known what is said during labour matters for how women experience birth. However, policy recommendations to staff about how to communicate with women in labour are not based on evidence about what actually happens in birth. This is because most existing research is based on interviewing or surveying women some weeks after birth, so the details of what was said in labour are lost. Research is needed that provides details of actual talk about decisions during labour. The details of talk matter because as other studies of communication in medical settings have shown, even small changes in use of words can make a difference to what happens in healthcare e.g. one study in a GP setting showed that changing from ‘is there anything else?’ to ‘is there something else?’ increased the
number of reported symptoms told to the doctor. The aim of this study is to find out how decisions are reached and communication through the talk that happens between staff, women in labour and their birth partners when giving birth in maternity units. It also aims to provide staff and women with detailed information about the effects of talk during labour in order to inform and empower staff, women and birth partners.
Who can participate?
Women , their birth partners and health care practitioners.
What does the study involve?
Participants who consent to taking part in the study are video or audio recorded during labour and birth. This is to establish how decisions are made during labour and birth. Participants are also asked to complete an ante-natal and a post –natal questionnaire at 35 weeks and 6 weeks post birth respectively to assess the relationship between their expectations before birth, their birth experience and their satisfaction post-birth.
What are the possible benefits and risks of participating?
There are no direct risks or benefits to those taking part in the study.
Where is the study run from?
1. University of York (UK)
2. Calderdale Royal Hospital (UK)
3. Sheffield Royal Hallamshire Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2017 to August 2020 (updated 07/04/2020, previously: March 2020)
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Professor Ellen Annandale (Scientific)
ellen.annandale@york.ac.uk
2. Dr Lyn Brierley-Jones (Public)
lyn.brierley-jones@york.ac.uk
Contact information
Scientific
University of York
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-5305-039X |
|---|---|
| Phone | +44 1904 324 561 |
| ellen.annandale@york.ac.uk |
Public
University of York
York
YO10 5DD
United Kingdom
| Phone | +44 1904 323 055 |
|---|---|
| lyn.brierley-jones@york.ac.uk |
Study information
| Study design | Three year observational multi centre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN16227678_PIS_01Aug17_V4.docx |
| Scientific title | Voices in Partnership/Video In Practice: Interactional practices of decision making during childbirth in maternity units |
| Study acronym | VIP |
| Study objectives | The aim of this study is find out how decisions are reached and communicated through the talk that happens between staff, women in labour and their birth partners when giving birth in maternity units. |
| Ethics approval(s) | South Yorkshire Research Ethics Committee, 15/05/2017, ref: 17/YH/0102 |
| Health condition(s) or problem(s) studied | Maternity Services |
| Intervention | A pilot study precedes this study and used the Conversation Analytic method for analysing data from ‘One Born Every Minute documentary created by Channel 4. The first year of the study is also an internal pilot but this is a pilot of recruitment not of the full methodology. If four analysable recordings are obtained by the end of this internal pilot period, then the full study can proceed. This study aims to video (or audio record if women prefer) the labours of 50 low-risk, full-term women and write down in full what was said and how it was said (e.g. laughing, sighing). Participants receive ante natal and post natal questionnaires to these women to ascertain what their expectations for birth were and whether these expectations were met during childbirth. Further, this study investigates how decisions are made during labour and how these impacted on outcomes. Health care professionals are also interviews: 10 at each site. In total, 12 midwives and 8 obstetricians are interviewed, all of varying professional grades. |
| Intervention type | Other |
| Primary outcome measure | Decision making is measured using the conversation analytic technique at the time of labour and birth. |
| Secondary outcome measures | Satisfaction is measured using both ante-natal and post-natal questionnaires at 35 weeks gestation and at 6 weeks post birth respectively. |
| Overall study start date | 01/05/2017 |
| Completion date | 12/08/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 women |
| Total final enrolment | 37 |
| Key inclusion criteria | 1. Women: any woman (aged 16+) attending two study two sites with a low risk, singleton pregnancy and who expects to have a vaginal birth at full-term in a midwife-led maternity unit (Sheffield) or birth centre (Calderdale). 2. Birth Partners: The women’s birth partners. 3. Healthcare Practitioners (HCPs): all clinical staff involved in maternity care at study sites. |
| Key exclusion criteria | 1. High risk pregnancy 2. Under 16 years of age |
| Date of first enrolment | 16/10/2017 |
| Date of final enrolment | 30/01/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
York
YO10 5DD
United Kingdom
Halifax
HX3 0PW
United Kingdom
Sheffield
S10 2SF
United Kingdom
Sponsor information
University/education
Heslington Village
York
SW1A 2NS
England
United Kingdom
| Phone | +44 1904 325 154 |
|---|---|
| michael.barber@york.ac.uk | |
| Website | www.york.ac.uk. |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Dissemination will be via two workshops in months 31-36 of the project and dissemination leaflets will be printed at this time. The RCM’s Progress Theatre Group will assist the project team in transferring the anonymised transcripts into artistic performance. By the end of month 36 a draft final report will have been submitted to NIHR and a first article submitted to a journal. These dissemination milestones will be achieved by 28/02/2020. |
| IPD sharing plan | We are not expecting to make our raw data publicly available in order to preserve the anonymity of women, their birth partners and health care practitioners. Anonymised data will be held by the University of York. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V4 | 01/08/2017 | 01/04/2019 | No | Yes |
| Protocol file | version V5 | 01/01/2018 | 01/04/2019 | No | No |
| Results article | 01/12/2022 | 17/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN16227678_PIS_01Aug17_V4.docx
- Uploaded 01/04/2019
- ISRCTN16227678_PROTOCOL_01Jan18_V5.docx
- Uploaded 01/04/2019
Editorial Notes
17/03/2023: Publication reference, IRAS and total final enrolment added.
07/04/2020: The following changes were made to the trial record:
1. The overall end date was changed from 30/03/2020 to 12/08/2020.
2. The plain English summary was updated to reflect these changes.
01/04/2019: The participant information sheet and protocol (not peer reviewed) have been uploaded.
