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

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

Study Overview

• Status: Recruiting
• Conditions: Hypertension in Pregnancy

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United Kingdom
  • London
    • London Borough Of Wandsworth, London, United Kingdom, SW17 0QT
      • Recruiting
      • St. George's University NHS Hopsitals
      • Contact: Elaine Sheehan, Msc; Phone Number: 07535558776; Email: elaine.sheehan@stgeorges.nhs.uk
      • Contact: Sam Hollingworth; Phone Number: 02082666488; Email: sahollin@sgul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected via purposive sampling as participants will need to have a diagnosis of gestational hypertension and/or pre-eclampsia to participate in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: St George's, University of London
• Collaborators: National Institute for Health Research, United Kingdom

Publications and helpful links

General Publications

• Sheehan E, Wang C, Cauldwell M, Bick D, Thilaganathan B. Understanding maternal postnatal blood pressure changes following hypertensive disorders in pregnancy: protocol for a prospective cohort study. BMJ Open. 2022 Apr 1;12(4):e060087. doi: 10.1136/bmjopen-2021-060087.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 2021.0199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No