Hypertension in PregnancyNCT05015049
Hypertensive Disorders of Pregnancy - the Neonatal Burden of Disease
An observational study of Hypertension in Pregnancy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Around one in ten women have high blood pressure in pregnancy. This is potentially serious, with risks to the woman and her baby. Whilst maternal deaths from high blood pressure in pregnancy are now rare in the UK, blood pressure problems in pregnancy still cause many stillbirths and early births. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension in Pregnancy
- How many people
- 823,957 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Babies born between 1st January 2012 and 31st December 2020 and admitted to a neonatal unit in England or Wales
Who may be able to join
- Must be born between 1st January 2012 and 31st December 2020
- Must be admitted to and received all care in a National Health Service (NHS) neonatal unit in England or Wales
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of the Neonatal Burden of Disease of Hypertensive Disorders of Pregnancy: a Population-based Study Using the National Neonatal Research Database
Around one in ten women have high blood pressure in pregnancy. This is potentially serious, with risks to the woman and her baby. Whilst maternal deaths from high blood pressure in pregnancy are now rare in the UK, blood pressure problems in pregnancy still cause many stillbirths and early births. Studies have shown that women of Black and Asian backgrounds are more likely to have worse pregnancy outcomes when blood pressure problems in pregnancy develop.
This study aims to:
Read more
- describe the burden of disease of high blood pressure in pregnancy amongst babies admitted to neonatal units on a national scale. ii) investigate outcomes for babies born to women with high blood pressure in pregnancy admitted to UK neonatal units across maternal ethnic groups.
To complete this study, we will use the National Neonatal Research Database, which holds population-level data for all babies admitted to neonatal units (where unwell babies receive care) in the UK. We will look at records of babies admitted to neonatal units in England and Wales between 2012 and 2020. The records will include information on over half a million babies and their mothers. We will assess how many babies admitted to neonatal units were born to women who had high blood pressure in pregnancy. We will report the outcomes of these babies, and how they compare to babies born to women without high blood pressure in pregnancy. We will analyse whether outcomes for babies born to women with high blood pressure in pregnancy varies according to maternal ethnicity, and investigate what may be driving differences we find.
Read the detailed description
Study Aims
This study aims to:
- quantify the proportion of all babies admitted to neonatal units born to women with a hypertensive disorder of pregnancy
- describe the national neonatal morbidity, mortality and resource use of babies admitted to neonatal units born to women with a hypertensive disorder of pregnancy
- examine ethnic disparities in neonatal outcomes of babies admitted to neonatal units born to women with hypertensive disorders of pregnancy.
The National Neonatal Research Database (NNRD)
The NNRD is an approved research database constituting real-world prospective clinical data extracted from point-of-care neonatal electronic health records with complete coverage of infants admitted for neonatal care to National Health Service (NHS) neonatal units in England and Wales (since 2012) and Scotland (since 2015). A defined data extract of approximately 450 items (the Neonatal Data Set) is transmitted quarterly to the Neonatal Data Analysis Unit at Imperial College London for data linkage and cleaning prior to entry into the NNRD. To date, the NNRD contains data for over a million babies (approximately 80,000 babies annually). High completeness and accuracy (>95%) of neonatal data held in the NNRD has been confirmed by formal comparison with a multicentre, randomised placebo-controlled trial.
Study Design
This study is a secondary analysis of an existing national electronic health record population cohort using anonymised, routinely recorded clinical data from the National Neonatal Research Database (NNRD). There will be no new patients recruited and there will be no changes made to patient care.
The research team will work with NNRD data analysts to extract anonymised data from the NNRD. A cohort of babies born to women with a hypertensive disorder of pregnancy (HDP) will be defined based on records of maternal medical problems prior to pregnancy, obstetrics problems during pregnancy, medications given during labour and neonatal discharge diagnoses. The morbidity, mortality and health resource use of this cohort will be described in depth. This cohort will also be compared to a cohort of babies born to women without a hypertensive disorder of pregnancy. The HDP cohort will also be stratified by maternal ethnicity to investigate disparities in outcomes.
- Conditions
- Hypertension in Pregnancy
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonatal population - hypertensive disorder of pregnancy | All babies born to a woman with a hypertensive disorder of pregnancy (HDP) and admitted to a neonatal unit in England and Wales between 1st January 2012 and 31st December 2020 | |
| Neonatal population - no hypertensive disorder of pregnancy | All babies born to a woman without a hypertensive disorder of pregnancy (HDP) and admitted to a neonatal unit in England and Wales between 1st January 2012 and 31st December 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to discharge from neonatal care
Survival to discharge from neonatal care
Measured: From birth to discharge or death, assessed up to 1 year
Primary recorded reason for neonatal unit admission
Primary recorded reason for neonatal unit admission
Measured: From birth to discharge or death, assessed up to 1 year
Length of stay in neonatal unit
Length of stay in neonatal unit
Measured: From birth to discharge or death, assessed up to 1 year
Number of days of intensive care
Number of days of intensive care
Measured: From birth to discharge or death, assessed up to 1 year
Secondary outcomes (20)
Survival to discharge from neonatal care without comorbidity
Survival to discharge from neonatal care without comorbidity
Measured: From birth to discharge or death, assessed up to 1 year
Cause of death
Cause of death
Measured: From birth to discharge or death, assessed up to 1 year
Age at death
Age at death
Measured: From birth to discharge or death, assessed up to 1 year
Discharge weight SDS (standard deviation score)
Discharge weight SDS (standard deviation score)
Measured: From birth to discharge or death, assessed up to 1 year
Birthweight centile (z-score)
Birthweight centile (z-score)
Measured: From birth to discharge or death, assessed up to 1 year
Clinical diagnoses potential specific to hypertensive disorders of pregnancy
Fetal growth restriction/intrauterine growth restriction, hypoglycaemia
Measured: From birth to discharge or death, assessed up to 1 year
General neonatal complications
Brain injury on imaging, necrotising enterocolitis, sepsis, jaundice, GI perforation
Measured: From birth to discharge or death, assessed up to 1 year
Preterm complications
Chronic lung disease/bronchopulmonary dysplasia, retinopathy of prematurity
Measured: From birth to discharge or death, assessed up to 1 year
Number of days of high-dependancy care
Number of days of high-dependancy care
Measured: From birth to discharge or death, assessed up to 1 year
Number of days of special care
Number of days of special care
Measured: From birth to discharge or death, assessed up to 1 year
Number of days of invasive respiratory support
Number of days of invasive respiratory support
Measured: From birth to discharge or death, assessed up to 1 year
Number of days of non-invasive respiratory support
Number of days of non-invasive respiratory support
Measured: From birth to discharge or death, assessed up to 1 year
Transfusion of blood products
Transfusion of blood products
Measured: From birth to discharge or death, assessed up to 1 year
Number of days of parenteral nutrition
Number of days of parenteral nutrition
Measured: From birth to discharge or death, assessed up to 1 year
Method of feeding (number of days of each e.g. NG, breast etc)
Method of feeding (number of days of each e.g. NG, breast etc)
Measured: From birth to discharge or death, assessed up to 1 year
Type of feeding (number of days of each e.g. breastmilk, formula etc)
Type of feeding (number of days of each e.g. breastmilk, formula etc)
Measured: From birth to discharge or death, assessed up to 1 year
Number of days nil by mouth
Number of days nil by mouth
Measured: From birth to discharge or death, assessed up to 1 year
Line type(s)
Line type(s)
Measured: From birth to discharge or death, assessed up to 1 year
Surfactant administered
Surfactant administered
Measured: From birth to discharge or death, assessed up to 1 year
Surfactant administered on first day
Surfactant administered on first day
Measured: From birth to discharge or death, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Jul 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 823,957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Battersby, Principal investigator, Imperial College LondonLucy Chappell, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015049
- Sponsor's protocol ID
- 295875
- Status last verified
- Oct 2024
- First submitted
- 10 Aug 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Neonatal Burden of Disease of Hypertensive Disorders of Pregnancy: a Population-based Study Using the National Neonatal Research Database
- ClinicalTrials.gov ID
- NCT05015049
- Acronym / sponsor ID
- 295875
- Conditions
- Hypertension in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 823,957 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Around one in ten women have high blood pressure in pregnancy. This is potentially serious, with risks to the woman and her baby. Whilst maternal deaths from high blood pressure in pregnancy are now rare in the UK, blood pressure problems in pregnancy still cause many stillbirths and early births. Studies have shown that women of Black and Asian backgrounds are more likely to have worse pregnancy outcomes when blood pressure problems in pregnancy develop.
This study aims to:
- describe the burden of disease of high blood pressure in pregnancy amongst babies admitted to neonatal units on a national scale. ii) investigate outcomes for babies born to women with high blood pressure in pregnancy admitted to UK neonatal units across maternal ethnic groups.
To complete this study, we will use the National Neonatal Research Database, which holds population-level data for all babies admitted to neonatal units (where unwell babies receive care) in the UK. We will look at records of babies admitted to neonatal units in England and Wales between 2012 and 2020. The records will include information on over half a million babies and their mothers. We will assess how many babies admitted to neonatal units were born to women who had high blood pressure in pregnancy. We will report the outcomes of these babies, and how they compare to babies born to women without high blood pressure in pregnancy. We will analyse whether outcomes for babies born to women with high blood pressure in pregnancy varies according to maternal ethnicity, and investigate what may be driving differences we find.
Detailed description
Study Aims
This study aims to:
- quantify the proportion of all babies admitted to neonatal units born to women with a hypertensive disorder of pregnancy
- describe the national neonatal morbidity, mortality and resource use of babies admitted to neonatal units born to women with a hypertensive disorder of pregnancy
- examine ethnic disparities in neonatal outcomes of babies admitted to neonatal units born to women with hypertensive disorders of pregnancy.
The National Neonatal Research Database (NNRD)
The NNRD is an approved research database constituting real-world prospective clinical data extracted from point-of-care neonatal electronic health records with complete coverage of infants admitted for neonatal care to National Health Service (NHS) neonatal units in England and Wales (since 2012) and Scotland (since 2015). A defined data extract of approximately 450 items (the Neonatal Data Set) is transmitted quarterly to the Neonatal Data Analysis Unit at Imperial College London for data linkage and cleaning prior to entry into the NNRD. To date, the NNRD contains data for over a million babies (approximately 80,000 babies annually). High completeness and accuracy (>95%) of neonatal data held in the NNRD has been confirmed by formal comparison with a multicentre, randomised placebo-controlled trial.
Study Design
This study is a secondary analysis of an existing national electronic health record population cohort using anonymised, routinely recorded clinical data from the National Neonatal Research Database (NNRD). There will be no new patients recruited and there will be no changes made to patient care.
The research team will work with NNRD data analysts to extract anonymised data from the NNRD. A cohort of babies born to women with a hypertensive disorder of pregnancy (HDP) will be defined based on records of maternal medical problems prior to pregnancy, obstetrics problems during pregnancy, medications given during labour and neonatal discharge diagnoses. The morbidity, mortality and health resource use of this cohort will be described in depth. This cohort will also be compared to a cohort of babies born to women without a hypertensive disorder of pregnancy. The HDP cohort will also be stratified by maternal ethnicity to investigate disparities in outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonatal population - hypertensive disorder of pregnancy | – | –All babies born to a woman with a hypertensive disorder of pregnancy (HDP) and admitted to a neonatal unit in England and Wales between 1st January 2012 and 31st December 2020 |
| Neonatal population - no hypertensive disorder of pregnancy | – | –All babies born to a woman without a hypertensive disorder of pregnancy (HDP) and admitted to a neonatal unit in England and Wales between 1st January 2012 and 31st December 2020 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Babies born between 1st January 2012 and 31st December 2020 and admitted to a neonatal unit in England or Wales
Key inclusion criteria (2 listed)
- Must be born between 1st January 2012 and 31st December 2020
- Must be admitted to and received all care in a National Health Service (NHS) neonatal unit in England or Wales
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival to discharge from neonatal care
Time frame: From birth to discharge or death, assessed up to 1 year
Survival to discharge from neonatal care
Primary recorded reason for neonatal unit admission
Time frame: From birth to discharge or death, assessed up to 1 year
Primary recorded reason for neonatal unit admission
Length of stay in neonatal unit
Time frame: From birth to discharge or death, assessed up to 1 year
Length of stay in neonatal unit
Number of days of intensive care
Time frame: From birth to discharge or death, assessed up to 1 year
Number of days of intensive care
20 secondary outcomes
Survival to discharge from neonatal care without comorbidity
Time frame: From birth to discharge or death, assessed up to 1 year
Cause of death
Time frame: From birth to discharge or death, assessed up to 1 year
Age at death
Time frame: From birth to discharge or death, assessed up to 1 year
Discharge weight SDS (standard deviation score)
Time frame: From birth to discharge or death, assessed up to 1 year
Birthweight centile (z-score)
Time frame: From birth to discharge or death, assessed up to 1 year
Clinical diagnoses potential specific to hypertensive disorders of pregnancy
Time frame: From birth to discharge or death, assessed up to 1 year
General neonatal complications
Time frame: From birth to discharge or death, assessed up to 1 year
Preterm complications
Time frame: From birth to discharge or death, assessed up to 1 year
Number of days of high-dependancy care
Time frame: From birth to discharge or death, assessed up to 1 year
Number of days of special care
Time frame: From birth to discharge or death, assessed up to 1 year
Number of days of invasive respiratory support
Time frame: From birth to discharge or death, assessed up to 1 year
Number of days of non-invasive respiratory support
Time frame: From birth to discharge or death, assessed up to 1 year
Transfusion of blood products
Time frame: From birth to discharge or death, assessed up to 1 year
Number of days of parenteral nutrition
Time frame: From birth to discharge or death, assessed up to 1 year
Method of feeding (number of days of each e.g. NG, breast etc)
Time frame: From birth to discharge or death, assessed up to 1 year
Type of feeding (number of days of each e.g. breastmilk, formula etc)
Time frame: From birth to discharge or death, assessed up to 1 year
Number of days nil by mouth
Time frame: From birth to discharge or death, assessed up to 1 year
Line type(s)
Time frame: From birth to discharge or death, assessed up to 1 year
Surfactant administered
Time frame: From birth to discharge or death, assessed up to 1 year
Surfactant administered on first day
Time frame: From birth to discharge or death, assessed up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Battersby principal investigator
Imperial College London
Lucy Chappell principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension in Pregnancy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to discharge from neonatal care (time frame: From birth to discharge or death, assessed up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.