Hypertensive Disorders of Pregnancy - the Neonatal Burden of Disease

NCT05015049 | Active Not Recruiting

• 1 other identifier: 295875
• Study Type: observational
• Target: 823,957
• Locations: 1 country
• Sites: 1

Brief 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. 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: i) 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.

Conditions

Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (4)

• Survival to discharge from neonatal care

  Survival to discharge from neonatal care

  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

  From birth to discharge or death, assessed up to 1 year

• Length of stay in neonatal unit

  Length of stay in neonatal unit

  From birth to discharge or death, assessed up to 1 year

• Number of days of intensive care

  Number of days of intensive care

  From birth to discharge or death, assessed up to 1 year

Secondary Outcomes (20)

• Survival to discharge from neonatal care without comorbidity

  From birth to discharge or death, assessed up to 1 year

• Cause of death

  From birth to discharge or death, assessed up to 1 year

• Age at death

  From birth to discharge or death, assessed up to 1 year

• Discharge weight SDS (standard deviation score)

  From birth to discharge or death, assessed up to 1 year

• Birthweight centile (z-score)

  From birth to discharge or death, assessed up to 1 year

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Babies born between 1st January 2012 and 31st December 2020 and admitted to a neonatal unit in England or Wales

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cheryl Battersby

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Lucy Chappell

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 20, 2021
• Study Start: July 1, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

GB (1)