Condition category
Pregnancy and Childbirth
Date applied
15/07/2019
Date assigned
16/07/2019
Last edited
16/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many women have a positive experience of birth, however some identify a gap between their expectations of birth and what happens. This mismatch has been linked with poor experience, distress and anxiety. Being well informed, having coping strategies and feeling in control during labour can enable a positive birth experience. Antenatal education is available. However, not all women attend the NHS classes and the content varies. As there is limited time to deliver this education, it is important that it is evidence-based, effective and efficient.

Who can participate?
To understand the current antenatal education, we will gather the opinions of women and staff about antenatal education.
To develop the intervention, we will invite women, their birth partners and staff from North Bristol NHS Trust, to take part in public patient involvement, alongside organisations advocating for women.

What does the study involve?
We will talk with patients about the current antenatal education at North Bristol NHS Trust
We will collaborate with women, birth-partners, organisations and staff to co-design a two hour antenatal education session and a short intervention to enable staff to support the coping strategies discussed in the session.
To understand antenatal education there will be 1-2 hour long focus groups with women and staff.
To test the intervention and compare it to standard care we will ask women to complete questionnaires before and after their session and 2 and 6 weeks after the birth of their baby. Birth partners will be asked to complete a questionnaire. We will ask staff to complete a questionnaire before and after attending a session, and one at 2 months.

What are the possible benefits and risks of participating?
Benefits of participating: Women, partners and staff will be participating in a study that may directly benefit their pregnancy experience. However, as the classes will only run in three of the community midwifery sites, it may be that women and partners are participating to benefit women in future.
Risks of participating: Women and staff will be asked to give their time. Women will be asked questions about their experience and levels of anxiety, depression and trauma. This may mean that women think about these issues more, or identify that they are struggling with them. As part of their clinical care team, we will take steps to support women if this happens.

Where is the study run from?
Southmead Hospital, Bristol, UK

When is the study starting and how long is it expected to run for?
July 2019 to August 2020

Who is funding the study?
1. Health Foundation
2. The David Telling Charitable Trust

Who is the main contact?
Dr Abi Merriel
abi.merriel@bristol.ac.uk


Trial website

https://www.nbt.nhs.uk/research-innovation/our-research/current-research

Contact information

Type

Scientific

Primary contact

Dr Abi Merriel

ORCID ID

http://orcid.org/0000-0003-0352-2106

Contact details

Population Health Sciences
University of Bristol
Department of Women's and Children's Health
The Chilterns
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
07740334922
abi.merriel@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41821

Study information

Scientific title

Antenatal Care Education (ACE): The co-design and piloting of interventions to improve patient and staff experience through better birth preparedness

Acronym

ACE

Study hypothesis

A co-designed antenatal and staff intervention can be implemented into practice and improve women’s experience.

Ethics approval

Approved 19/06/2019, NHS HRA (South West - Frenchay Research Ethics Committee, Level 3, Block B
Whitefriars, Lewins Mead, Bristol, BS1 2NT; nrescommittee.southwest-frenchay@nhs.net; 0207 104 8210), ref: 19/SW/0073

Study design

Non-randomised; Both; Design type: Process of Care, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Management of Care, Qualitative

Primary study design

Other

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

General Obstetrics (antenatal and postnatal care, perinatal mental health)
Reproductive health and childbirth

Intervention

There are 5 parts to this study, which will enable us to build up a clear picture of antenatal education in the UK. The multiple designs have been selected carefully to ensure that we develop a detailed picture of what women want locally. Further to this, we will ensure that we situate the design of the final interventions in the national situation. The contact these work packages enable with other NHS organisations and stakeholders in antenatal education will try to ensure that we harness existing resources.
Work package 1: focus group sessions: women from antenatal classes
Work package 2: qualitative study of staff's perspectives of antenatal education
Work package 3: cognitive interviewing and testing of pilot tool for measuring expectations
Work package 4: controlled pilot study of antenatal education session for women
Work package 5: pilot study of intervention for staff

Focus Groups with Women (Work Package 1), Research and clinical staff on the research team from NBT and UoB at an NBT/Community site
Focus Groups with Staff (Work Package 2), Research and clinical staff on the research team from NBT and UoB at an NBT/Community site
Think Aloud Interviews with Women (Work Package 3), Research and clinical staff on the research team from NBT and UoB at an NBT/Community site; Expectations of birth questionnaire (Work Package 4), The women will complete a questionnaire on paper or online before the session and 1-2 weeks after the session.
Staff Intervention feedback (Work Package 5), Staff will be asked to complete a feedback form immediately following the intervention, in whichever clinical area the intervention takes place. A member of the study team will collect these responses.
Staff satisfaction with work scale (Work Package 5), Staff will be asked to complete the questionnaire twice either on paper prior to the session or online. They will then be asked to complete it again 2-3 months after the intervention.
Staff pilot intervention (Work Package 5), Staff will be invited to attend a brief intervention about coping strategies delivered at NBT in the clinical areas in which staff work. The intervention will be delivered by a member of the research team.
Feedback about sessions from women and birth partners (Work Package 4), We will ask women to complete the questionnaire immediately following the session which takes place at at an NBT/Community site
Clinical Information about delivery (Work Package 4), This will be collected from case notes by clinical members of the research team. However, for women who have their baby outside of NBT, we will phone the women at the same time as the follow up questionnaires and ask them for the information.
Outcome assessment (Work Package 4), This will be a paper, online or telephone completion of a questionnaire by the women whilst they are at home at 2 and 6 weeks postnatal.
Staff debrief (Work Package 4), Members of the research team will debrief community midwifery staff delivering the intervention using a structured debrief form at an NBT/Community site where the session has taken place
Staff delayed intervention feedback (Work Package 5), Staff will be asked to complete a feedback form 2-3 months following the intervention, either on paper or online.
Pilot or standard antenatal education intervention (Work Package 4), Community Midwives who will routinely deliver care, will deliver either their standard or the new intervention at an NBT/Community site

Intervention type

Other

Phase

Drug names

Primary outcome measure

The main outcome for the study will be the production and piloting of the interventions, there will be no primary outcome as the study is not powered to detect any differences, as it is pilot work.

Secondary outcome measures

For WP1 & 2 the outcomes will be an understanding of the current landscape of women's antenatal education, coping strategies and expectations.
For WP3 we will produce an expectations questionnaire.
For WP 4:
Process Measures:
4.1 Number of women and partners attending the sessions
4.2 Immediate feedback on the intervention from women and partners
4.3 Delayed feedback on the utility of the intervention via a postnatal survey at 2 and 6 weeks.
4.4 Debrief with staff delivering the intervention for 10 minutes post intervention recorded on a structured form by a member of the research team.
Intervention Fidelity:
4.5 Length of session delivered, as timed by the research team member
4.6 Content delivered as reported by the community midwife
4.7 Research team assessment of fidelity of intervention via audio-recording.
Outcome Assessment
4.8 expectations of labour and birth questionnaire - change pre-post intervention
4.9 birth outcomes
4.10 2 and 6 weeks questionnaire to record the childbirth experience questionnaire, Edinburgh postnatal depression scale, the Generalised Anxiety Disorder Scale, and a PTSD Scale.
For WP 5:
Process Measures:
5.1 Number of staff attending the intervention will be collected
5.2 Immediate feedback on the intervention from staff
5.3 Delayed feedback on the utility of the intervention via a survey at 2-3 months
Outcome Assessment
5.4 All staff consenting to participate in the sessions will be asked to complete a satisfaction with work scale before the study and 3 months later

Overall trial start date

01/01/2019

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

There are five work packages (WPs), with separate inclusion criteria:
WP1: Aged > 16, invited to attend/attended ANE Class in North Bristol NHS Trust (NBT)
WP2: Any clinical role, involved in labour/delivery care at NBT
WP3: Aged > 16, either antenatal or postnatal NBT patient
WP4: Women and partners attending ANE at NBT, willing to participate and can complete an english questionnaire
WP5: All clinical staff involved in labour and delivery care at NBT

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 611; UK Sample Size: 611

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

16/07/2019

Recruitment end date

30/04/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
North Bristol NHS Trust Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Southmead Hospital
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
0117 41 49330
researchsponsor@nbt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Foundation; Grant Codes: 1109133

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The David Telling Charitable Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes