Condition category
Pregnancy and Childbirth
Date applied
06/05/2015
Date assigned
18/08/2015
Last edited
18/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study will look at the effectiveness of a community intervention programme to support women to have their first antenatal appointment with maternity services before the 13th week of pregnancy, in line with national guidelines. The study is part of a wider NIHR-funded programme of research that seeks to improve access to and experience of antenatal care for pregnant women living in socially deprived and ethnically diverse areas - the REACH Pregnancy Programme.

Who can participate?
Women who are pregnant/give birth during the time frame of the study and live in one of the 20 electoral wards in North and East London where women are more likely to delay the start of antenatal care.

What does the study involve?
We will randomly select 10 of the 20 wards as the ones where the community programme will take place. The programme will include: training a group of peer volunteers to promote antenatal care through local networks of women; development and distribution of campaign materials; and community events to promote key messages. We will work together with local communities to co-design and develop the content of the programme. We will analyse hospital data from local maternity services to see whether pregnant women living in the programme wards begin their antenatal care earlier, and see greater benefits for both themselves and their babies, than those living in the other 10 wards. We will look at whether the programme provides good value for money. We will also interview local people who help design and deliver the programme, in order to identify issues that supported or hindered its effectiveness within their communities. Finally, we will survey some pregnant women living in the study wards to see whether or not the programme influenced their decision about when to begin antenatal care.

What are the possible benefits and risks of participating?
The potential cost-effective benefits of increasing rates of early antenatal booking are improved health outcomes for women and children, through early identification of any health needs, uptake of time-specific screening tests, monitoring of the pregnancy, advice and support around healthy behaviour. The enhanced social support available from the community is also expected to be beneficial. The intervention is also expected to benefit the members of the community recruited to design and deliver it. Benefits may include satisfaction gained from their role and acquisition of new knowledge and skills that may enhance employability. There are no anticipated risks to participants. However, as in all interventions, there may be unanticipated risks. It is possible given the intended ‘reach’ of the intervention into whole communities and not just women of child-bearing age that attempts to change service use behaviour may meet with resistance from some sections of the culturally diverse communities involved. This could create a dilemma for pregnant women who want to act on the message of the intervention but do not have support for this from their family/community. It is hoped that the co-design approach will minimise this risk.

Where is the study run from?
University of East London (UK).

When is the study starting and how long is it expected to run for?
From April 2015 to April 2016.

Who is funding the study?
NIHR Programme Grants for Applied Research (UK).

Who is the main contact?
Dr Lorna Sweeney
l.sweeney@uel.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lorna Sweeney

ORCID ID

http://orcid.org/0000-0002-1630-467X

Contact details

Institute of Health & Human Development
Water Lane
London
E15 4LZ
United Kingdom

Type

Scientific

Additional contact

Ms Mary Sawtell

ORCID ID

Contact details

Department of Childhood
Families and Health
Social Science Research Unit
UCL Institute of Education
University College London
20 Bedford Way
London
WC1H 0AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18723

Study information

Scientific title

A pragmatic cluster population-level randomised controlled trial of a community-level intervention to increase early uptake of antenatal care (REACH Pregnancy Programme, Work Package 1)

Acronym

Study hypothesis

This study will look at the effectiveness of a community intervention programme to support women to have their first antenatal appointment with maternity services before the 13th week of pregnancy, in line with national guidelines. The study is part of a wider NIHR-funded programme of research that seeks to improve access to and experience of antenatal care for pregnant women living in socially deprived and ethnically diverse areas - the REACH Pregnancy Programme.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=18723

Ethics approval

First MREC approval date 27/03/2015; 15/NE/0106

Study design

Both; Observational; Design type: Qualitative

Primary study design

Observational

Secondary study design

Qualitative

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth

Intervention

REACH community: a community-based intervention that is designed and delivered in partnership with local community members which aims to support pregnant women to have their first antenatal appointment with maternity services before the 13th week of pregnancy, in line with national guidelines

Intervention type

Other

Phase

Drug names

Primary outcome measures

The primary outcome measure, assessed at ward level, will be the proportion of pregnant women who have attended their antenatal booking appointment by the end of the 12th completed week of their pregnancy. Timepoint(s): All outcomes will be measured at baseline (T1), 2 – 7 months (T2) and 8-13 months (T3) post intervention start, using routine maternity service data.

Secondary outcome measures

1. Antenatal admissions
2. Emergency caesarean rates
3. Pre-term birth and low birth weight
All outcomes will be measured at baseline (T1), 2 – 7 months (T2) and 8-13 months (T3) post intervention start, using routine maternity service data.

Overall trial start date

01/04/2015

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Cluster RCT – inclusion criteria:
1. Trust level - Able to provide the routine maternity data required for randomisation and for assessment of outcomes. For both tasks we require 'gestation at booking' data and for outcomes assessment we also require data on various birth outcomes. All routine data is required at ward level.
2. Cluster (site) level - Electoral wards, covered by maternity care providers enrolled on the study, where the proportion of women who have their first antenatal appointment by 12 weeks is below the NHS national target of 90%. Electoral wards to be included in the study must also be geographically spread out in order to reduce the potential for contamination in control sites.
3. Individual level - All women who are pregnant/give birth during the time frame of the study and live in one of the 20 intervention or control wards selected for the study. (There will be no active recruitment of participants as outcomes will be measured at ward level using routinely collected data).

Co-design process – inclusion criteria:
1. Any person (e.g. resident of local community, healthcare professional working in the community, community organisation volunteer or staff member) who is over the age of 16 and is interested in collaboratively developing intervention messages and materials for the local community concerning antenatal care.
2. Those co-design participants who match the inclusion criteria for peer volunteers (local women who share the same socio-demographic profile as groups vulnerable to late initiation of ANC) can continue their involvement through into the implementation and delivery phase.

Research interviews with co-design participants and peer volunteers – inclusion criteria:
1. We will potentially interview any person (e.g. resident of local community, healthcare professional working in the community, community organisation staff member) who participated in a community event, workshop, or other activity to collaboratively design content, messages and materials for the community intervention around antenatal care.
2. We will also interview peer volunteers who were involved in the co-design process and who delivered intervention messages and materials to local women within their communities.
3. We will only interview people over the age of 16.

Survey with pregnant women – inclusion criteria:
1. Pregnant women who live in intervention or control wards, and attend the antenatal clinic of a Trust enrolled on the study at least three months following the implementation of the intervention.
2. We will survey any potential participants aged 16 years and over who consent to the research. Any young women aged 16-18 years who we survey will have already been assessed by maternity staff as competent to provide informed consent to participate in antenatal care and maternity services (parental consent will not be requested for them to access services). As such, we believe that any young pregnant woman aged 16-18 years who is asked to take part in this survey will be competent to provide consent for themselves, without asking for additional consent from parents or guardians. Their inclusion in the research is vital, as this group is one at risk of higher rates of late access to ANC.

Target Gender: Male & Female; Upper Age Limit 100 years ; Lower Age Limit 16 years

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 440; UK Sample Size: 440; Description: Randomised element of study (Cluster RCT) refers to non-consenting participants that will not be uploaded. The non-randomised element refers to surveys and interviews with 440 consented participants.

Participant exclusion criteria

Cluster RCT - exclusion criteria:
1. Cluster (site) level - electoral wards, covered by maternity care providers enrolled on the study, where the proportion of women who have their first antenatal appointment by 12 weeks is above the NHS national target of 90%. We will also not include electoral wards which are geographically close to one another, as this increases the possibility of contamination between intervention and control sites.
2. Individual level – women who are pregnant/give birth during the time frame of the study with the maternity care providers enrolled on the study, but who do not live in one of the 20 wards selected for the study.

Co-design process - exclusion criteria:
Anyone under the age of 16.

Research interviews with co-design participants and peer volunteers - exclusion criteria:
1. People within the intervention communities who are not involved in any aspect of the co-design process and/or the delivery of the intervention messages.
2. We will also not interview people under the age of 16 years.

Survey with pregnant women - exclusion criteria:
1. Pregnant women attending the antenatal clinic of a Trust enrolled on the study who do not live in intervention or control wards.
2. We will not survey anyone who is under the age of 16. Additionally, where maternity staff are concerned that a woman is not competent to consent to participate in services, then they will not be invited to participate in the survey research.

Recruitment start date

01/04/2015

Recruitment end date

30/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of East London
Institute of Health & Human Development Water Lane
London
E15 4LZ
United Kingdom

Sponsor information

Organisation

University of East London (UK)

Sponsor details

Institute of Health & Human Development
Water Lane
London
E15 4LZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Programme Grants for Applied Research (UK); Grant Codes: RP-PG-1211-20015

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are currently in the final stages of preparing the study protocol to be submitted for publication in an academic journal. Study findings (available approx. end 2017) will be presented at national/international conferences, published in peer-reviewed academic journals and accessible formats in newsletters for women and in professional and practitioner journals. The findings will also be reported as briefing papers to healthcare commissioners and managers. We will use links with the Reproductive and Childbirth topic network to further disseminate throughout the NHS. We will present our findings at the Royal Colleges of Midwives annual conference, the International Confederation of Midwives and relevant national public health conferences. Lay representatives will be included in these dissemination activities.

Data that is suitable for open sharing will be stored (along with relevant metadata and documentation) in the UEL data repository, data.uel, without any restrictions (Open Data). As this data is anonymised/not personal no security will be required. This data will be reviewed every 5 years in accordance with UEL Research Data Management policy (http://www.uel.ac.uk/wwwmedia/services/library/lls/resources/rspresearchtools/Research-Data-Management-policy-for-UEL-FINAL.pdf), and if appropriate destroyed.

Intention to publish date

31/12/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes