Understanding Blood Pressure Changes After Birth

NCT ID: NCT05137808

Last Updated: 2022-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-09

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Hypertension in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. George's University NHS Hopsitals

Wandsworth, London, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Elaine Sheehan, Msc

Role: primary

07535558776

Sam Hollingworth

Role: backup

02082666488

References

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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.

Reference Type DERIVED
PMID: 35365547 (View on PubMed)

Other Identifiers

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2021.0199

Identifier Type: -

Identifier Source: org_study_id

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