Understanding Blood Pressure Changes After Birth
- Conditions
- Hypertension in Pregnancy
- Registration Number
- NCT05137808
- Lead Sponsor
- St George's, University of London
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 300
- 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).
• Pre-existing hypertension
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of persistent hypertension in postpartum period 12 weeks Blood Pressure expressed as mmHg at twelve weeks postpartum via 24 hour ambulatory blood pressure monitoring.
- Secondary Outcome Measures
Name Time Method Levels of agreement of diastolic and systolic blood pressures between HBPM and ABPM measurements 12 weeks Accuracy 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 surveillance 12 weeks Using 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 birth 10 weeks Based 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
Trial Locations
- Locations (1)
St. George's University NHS Hopsitals
🇬🇧London Borough Of Wandsworth, London, United Kingdom