Condition category
Pregnancy and Childbirth
Date applied
16/01/2018
Date assigned
13/02/2018
Last edited
13/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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

Trial website

https://www.york.ac.uk/sociology/research/current-research/vip/)

Contact information

Type

Scientific

Primary contact

Prof Ellen Annandale

ORCID ID

http://orcid.org/0000-0002-5305-039X

Contact details

University of York
York
YO10 5DD
United Kingdom
+44 1904 324 561
ellen.annandale@york.ac.uk

Type

Public

Additional contact

Dr Lyn Brierley-Jones

ORCID ID

Contact details

University of York
York
YO10 5DD
United Kingdom
+44 1904 323 055
lyn.brierley-jones@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14/70/73

Study information

Scientific title

Voices in Partnership/Video In Practice: Interactional practices of decision making during childbirth in maternity units

Acronym

VIP

Study hypothesis

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

South Yorkshire Research Ethics Committee, 15/05/2017, ref: 17/YH/0102

Study design

Three year observational multi centre study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

We have three participant information sheets that correspond to the three groups taking part in the study: pregnant women, health care practitioners and birth partners. I have attached copies of all three information sheets to this email.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/05/2017

Overall trial end date

30/03/2020

Reason abandoned

Eligibility

Participant 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.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

50 women

Participant exclusion criteria

1. High risk pregnancy
2. Under 16 years of age

Recruitment start date

16/10/2017

Recruitment end date

30/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
Heslington
York
YO10 5DD
United Kingdom

Trial participating centre

Calderdale Royal Hospital
Salterhebble
Halifax
HX3 0PW
United Kingdom

Trial participating centre

Sheffield Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2SF
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

Heslington Village
York
SW1A 2NS
United Kingdom
+44 1904 325 154
michael.barber@york.ac.uk

Sponsor type

University/education

Website

www.york.ac.uk.

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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 statement:
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.

Intention to publish date

28/02/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes