Understanding Blood Pressure Changes After Birth

Hypertension in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137808
• Other study ID #: 2021.0199
• Status: Recruiting
• Start date: May 9, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced

Locations

Country	Name	City	State
United Kingdom	St. George's University NHS Hopsitals	London Borough Of Wandsworth	London

Sponsors (2)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of persistent hypertension in postpartum period	Blood Pressure expressed as mmHg at twelve weeks postpartum via 24 hour ambulatory blood pressure monitoring.	12 weeks
Secondary	Levels of agreement of diastolic and systolic blood pressures between HBPM and ABPM measurements	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.	12 weeks
Secondary	Identification of women who would benefit from closer BP surveillance	Using univariate logistic regression to assess what variables such as age, BMI, ethnicity, etc are associated with persistent hypertension at twelve weeks postpartum.	12 weeks
Secondary	Key time points when BP should be monitored post birth	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	10 weeks