Community intervention to increase early uptake of antenatal care
- Conditions
- Topic: Reproductive health and childbirthSubtopic: Reproductive Health and Childbirth (all Subtopics)Disease: Reproductive Health & ChildbirthPregnancy and Childbirth
- Registration Number
- ISRCTN63066975
- Lead Sponsor
- City, University of London
- Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29506563 protocol
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 12068
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 1. Antenatal admissions<br>2. Emergency caesarean rates<br>3. Pre-term birth and low birth weight<br>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.