Plain English Summary
Background and study aims
High blood pressure in pregnancy is an increasingly common complication that increases the risk of adverse pregnancy outcomes including maternal and infant death, damage to the mother’s liver and kidneys, and premature birth. The impact of high blood pressure in pregnancy on women’s health and wellbeing in the postnatal period is not well understood, along with the extent to which current postnatal services are evidence-informed and if they are meeting women’s needs. This study aims to compare the postnatal health of, and the care provided to, women who had high blood pressure in pregnancy compared with women who had normal blood pressure in pregnancy.
Who can participate?
Women aged 18 or above who gave birth in any of the participating NHS foundation trusts
What does the study involve?
Eligible women are approached and provided with study information on the postnatal ward and those happy to participate are asked to complete a consent form and short (5 minute) questionnaire. Following this initial contact at about three months postnatal participating women are invited to complete a 15-minute questionnaire with questions on their physical health, mental health, their babies feeding habits and the postnatal care they received.
What are the possible benefits and risks of participating?
The study findings will be used to provide evidence on if, and how, postnatal health differs amongst women with more complex pregnancies, compared to lower risk pregnancies, and if care beyond birth is meeting these women’s needs, with the view of informing revisions to current postnatal services.
Where is the study run from?
1. Guys and St Thomas’ NHS Foundation Trust (UK)
2. King's College Hospital NHS Foundation Trust (UK)
3. Kingston Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2018 to June 2020
Who is funding the study?
1. NIHR CLAHRC South London (UK)
2. NIHR Academy (UK)
Who is the main contact?
Dr Danielle Ashworth
danielle.c.ashworth@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Danielle Ashworth
ORCID ID
Contact details
King's College London
Department of Women and Children’s Health
10th floor
North Wing
St Thomas’ Hospital
London
SE1 7EH
United Kingdom
-
danielle.c.ashworth@kcl.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
40501
Study information
Scientific title
Postnatal health and care following hypertensive disorders in pregnancy: a prospective cohort study
Acronym
BPiPP
Study hypothesis
1. Do women with hypertensive disorders in pregnancy experience greater postnatal physical and psychological morbidity compared to women with normal blood pressure in pregnancy?
2. Does the extent and characterisation of postnatal morbidity differ between women with hypertensive disorders in pregnancy and women with normal blood pressure in pregnancy?
3. Do women with hypertensive disorders in pregnancy receive additional postnatal care (contacts and content in line with relevant NICE guidance) compared to women with normal blood pressure in pregnancy?
Ethics approval
London - South East Research Ethics Committee, Barlow House 3rd Floor 4 Minshull Street Manchester M1 3DZ, Tel: +44 (0)207 104 8014, +44 (0)207 104 8002, Email: nrescommittee.london-southeast@nhs.net, 21/12/2018, ref: 18/LO/2084
Study design
Observational; Design type: Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Hypertension during pregnancy
Intervention
Eligible women will be approached and provided with study information on the postnatal ward and those happy to participate will be asked to complete a consent form and short (5 minute) questionnaire. Following this initial contact at approximately 3 months postnatal participating women will be invited to complete a 15 minute questionnaire, with questions included on their: physical health, mental health, their babies feeding habits and the postnatal care they received. BPiPP study findings will be used to provide evidence on if, and how, postnatal health differs amongst women with more complex pregnancies, compared to lower risk pregnancies, and if care beyond birth is meeting these women’s needs, with the view of informing revisions to current postnatal services.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Co-primary outcomes for research question 1:
1. Depressive symptoms, measured using the Edinburgh Postnatal Depression Score (EPDS) questionnaire (mean and threshold scores ≥13 - standard cut-off score recommended when screening for probable major depression), at 3 months postnatal
2. Health status, measured using the EuroQol Group five dimension (EQ-5D) questionnaire (mean score on the vertical visual analogue scale score), at 3 months postnatal
Primary outcomes for research question 2:
Presence and severity of morbidities measured from patient reported study survey responses at 3 months postnatal
Primary outcome for research question 3:
Women’s opinion of their postnatal care contacts and content and measures of NICE guidance adherence measured from patient reported study survey responses at 3 months postnatal
Secondary outcome measures
Patient reported study survey responses at 3 months postnatal will also capture:
1. Other physical and psychological morbidity outcomes (including EQ-5D level per domain)
2. Re-admission rates
3. Breastfeeding uptake and duration rates
4. Mean number of visits/contacts with NHS services
Overall trial start date
01/06/2018
Overall trial end date
01/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women who gave birth in any of the participating NHS foundation trusts
2. Women who gave birth at > = 20+0 weeks gestation
3. Women aged 18 or above
4. Women able to provide informed consent
5. Study participants unable to compete questionnaires due to lack of English fluency will be offered use of translation facilities used in clinical practice at each site
6. Study participants who experience a neonatal death between baseline and follow up questionnaire completion will be contacted to ask if they would like to continue participating in BPiPP or withdraw
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 1000; UK Sample Size: 1000
Participant exclusion criteria
1. Women who gave birth in any non-participating NHS foundation trusts
2. Women who gave birth at < 20+0 weeks gestation
3. Women under 18 years old
4. Women unable to provide informed consent
Recruitment start date
06/02/2019
Recruitment end date
21/01/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guys and St Thomas’ NHS Foundation Trust
St Thomas’ Hospital
Westminster Bridge Rd
Lambeth
London
SE1 7EH
United Kingdom
Trial participating centre
King's College Hospital NHS Foundation Trust
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Trial participating centre
Kingston Hospital NHS Foundation Trust
Kingston Hospital
Galsworthy Road
Kingston upon Thames
KT2 7QB
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
c/o Reza Razavi
Room 5.31
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)207 8483224
reza.razavi@kcl.ac.uk
Sponsor type
University/education
Website
Organisation
Guy's & St Thomas' Foundation NHS Trust
Sponsor details
c/o Jennifer Boston
R&D Department
16th Floor
Tower Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)2071885733
R&D@gstt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR CLAHRC South London
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NIHR Academy
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned dissemination of study findings through conventional academic outputs including publication in peer reviewed journals and academic conferences in addition to via websites of collaborating hospitals and appropriate groups such as support groups and charities. Study participants requesting a copy of the study results will be provided with a summary report.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository MedSciNet. CI, study coordinator, PIs and recruiting research staff will have access to the BPiPP database. Consent from participants will be obtained and all participants will be identified by a unique study ID.
Intention to publish date
01/06/2021
Participant level data
Stored in repository
Basic results (scientific)
Publication list