Blood pressure in the postnatal period
| ISRCTN | ISRCTN10809239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10809239 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 249428 |
| Protocol serial number | 40501 |
| Sponsors | King's College London, Guy's & St Thomas' Foundation NHS Trust |
| Funders | NIHR CLAHRC South London, NIHR Academy |
- Submission date
- 04/02/2019
- Registration date
- 06/02/2019
- Last edited
- 06/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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. King's College Hospital NHS Foundation Trust (UK)
2. Kingston Hospital NHS Foundation Trust (UK)
3. Ashford and St. Peter's Hospitals NHS Foundation Trust (UK)
4. Chelsea and Westminster Hospital NHS Foundation Trust (UK)
5. St George's University Hospitals NHS Foundation Trust (UK)
6. Manchester University NHS Foundation Trust (UK)
7. Salisbury NHS Foundation Trust (UK)
8. Lewisham and Greenwich NHS Trust (UK)
9. University Hospitals Coventry & Warwickshire NHS Trust (UK)
10. Western Sussex Hospitals NHS Foundation Trust (UK)
11. Croydon Health Services NHS Trust (UK)
12. Oxford University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2018 to September 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
Contact information
Scientific
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 |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational; Design type: Cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Postnatal health and care following hypertensive disorders in pregnancy: a prospective cohort study |
| Study acronym | BPiPP |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Co-primary outcomes for research question 1: |
| Key secondary outcome measure(s) |
Patient reported study survey responses at 3 months postnatal will also capture: |
| Completion date | 30/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 1000 |
| Total final enrolment | 1829 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/02/2019 |
| Date of final enrolment | 31/03/2020 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
KT16 0PZ
United Kingdom
Denmark Hill
London
SE5 9RS
United Kingdom
Galsworthy Road
Kingston upon Thames
KT2 7QB
United Kingdom
TW7 6AF
United Kingdom
London
SW17 0QT
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
SP2 8BJ
United Kingdom
SE18 4QH
United Kingdom
Coventry
CV2 2DX
United Kingdom
PO19 6SE
United Kingdom
Croydon
Surrey
CR7 7YE
United Kingdom
Headley Way
Oxford
OX3 9DU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 05/04/2022 | 05/05/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/05/2022: The IRAS number has been added.
05/05/2022: Publication reference added.
09/08/2021: The intention to publish date was changed from 01/06/2021 to 01/12/2021.
21/09/2020: The total final enrolment number has been added.
11/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 21/01/2020 to 31/03/2020.
2. The overall trial end date has been changed from 01/06/2020 to 30/09/2020.
3. The trial participating centres "Ashford and St. Peter's Hospitals NHS Foundation Trust", "Chelsea and Westminster Hospital NHS Foundation Trust", "St George's University Hospitals NHS Foundation Trust", "Manchester University NHS Foundation Trust", "Salisbury NHS Foundation Trust", "Lewisham and Greenwich NHS Trust", "University Hospitals Coventry & Warwickshire NHS Trust", "Western Sussex Hospitals NHS Foundation Trust", "Croydon Health Services NHS Trust" and "Oxford University Hospitals NHS Foundation Trust" have been added.
4. The trial participating centre "Guys and St Thomas’ NHS Foundation Trust" has been removed.
5. The plain English summary has been updated to reflect the changes above.
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.
