Condition category
Pregnancy and Childbirth
Date applied
04/02/2019
Date assigned
06/02/2019
Last edited
22/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

22/03/2019: The condition has been changed from "Specialty: Reproductive Health and Childbirth, Primary sub-specialty: Other; Health Category: Reproductive health and childbirth; Disease/Condition: Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium" to "Hypertension during pregnancy" following a request from the NIHR. 11/02/2019: Internal review.