Skip to content

Understanding Blood Pressure Changes After Birth

A Prospective Cohort Study, Understanding Blood Pressure Changes in the Immediate Twelve Weeks Postpartum for Women Who Had a Hypertensive Disorder in Pregnancy and How Existing Care Pathways Identify and Monitor Women at Risk of Cardiovascular Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05137808
Enrollment
300
Registered
2021-11-30
Start date
2022-05-09
Completion date
2023-12-31
Last updated
2022-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension in Pregnancy

Brief summary

Research Question How does maternal blood pressure respond in the postpartum period for women who had a hypertensive disorder in pregnancy? Aim To evaluate the recovery of maternal blood pressure after a pregnancy affected by new onset hypertension after twenty weeks gestation Objectives * To identify rates of persistent hypertension after pregnancies affected by HDP * To assess and compare the accuracy of HBPM against the gold standard of ABPM * To assess the maternal acceptance of HBPM and ABPM * To explore what CVD-related care information is provided at the 6-8 week GP appointment

Detailed description

This research aims to investigate how women's blood pressure responds after birth and assess the time it takes to return to normal ranges. This will be calculated by participants undertaking three consecutive days of home blood pressure monitoring, every fortnight from two until twelve weeks postpartum. At twelve weeks postpartum, women will have a twenty-four ambulatory blood pressure assessment. This will highlight the prevalence of persistent high blood pressure and how often GPs will need to monitor women's blood pressure in the immediate few weeks after birth. Women will be asked to complete a questionnaire after their six to eight week GP appointment, assessing if women recall having their blood pressure checked and/or the risks of heart disease explained to them and if they received any lifestyle advice to reduce these risks. Women will be asked to complete a second questionnaire at twelve weeks postpartum assessing their acceptance and preference of home and twenty four hour blood pressure monitoring. This research aims to identify any gaps in the current care of women in the postnatal period and use this information to provide better quality of care to women so they can lead healthier lives and reduce their risk of heart disease.

Interventions

None listed

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
St George's, University of London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum

Inclusion criteria

* Pregnant women with a confirmed diagnosis of new onset of high blood pressure after twenty weeks gestation * Maternal Age \>16 years old * Mental capacity to give informed consent * Ability to be able to communicate to HCP if their BP range is above target (for example women where English is not their first language).

Exclusion criteria

• Pre-existing hypertension

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of persistent hypertension in postpartum period12 weeksBlood Pressure expressed as mmHg at twelve weeks postpartum via 24 hour ambulatory blood pressure monitoring.

Secondary

MeasureTime frameDescription
Levels of agreement of diastolic and systolic blood pressures between HBPM and ABPM measurements12 weeksAccuracy of HBPM for diagnosing hypertension and pre-hypertension will assessed by sensitivity, specificity, PPV and NPV analysis and Cohen's Kappa will measure the agreement between both. ICC and Bland Altman plots will assess agreement between continuous variables (SBP+DBP) and assess for systematic effects.
Identification of women who would benefit from closer BP surveillance12 weeksUsing univariate logistic regression to assess what variables such as age, BMI, ethnicity, etc are associated with persistent hypertension at twelve weeks postpartum.
Key time points when BP should be monitored post birth10 weeksBased on most prevalent time points when BP is at it's highest according to two weekly intervals from week 2 to week 12 post birth

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026