Understanding Blood Pressure Changes After Birth

Sponsor
St George's, University of London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05137808
Collaborator
National Institute for Health Research, United Kingdom (Other)
300
1
19.7
15.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    May 9, 2022
    Anticipated Primary Completion Date :
    Aug 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. George's University NHS Hopsitals London Borough Of Wandsworth London United Kingdom SW17 0QT

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St George's, University of London
    ClinicalTrials.gov Identifier:
    NCT05137808
    Other Study ID Numbers:
    • 2021.0199
    First Posted:
    Nov 30, 2021
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 20, 2022