Clinical trial NCT05137808: Understanding Blood Pressure Changes After Birth
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension in Pregnancy
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2021-11-30
Enrollment: 300
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of persistent hypertension in postpartum period
timeFrame: 12 weeks
Secondary outcomes:
measure: Levels of agreement of diastolic and systolic blood pressures between HBPM and ABPM measurements
timeFrame: 12 weeks
measure: Identification of women who would benefit from closer BP surveillance
timeFrame: 12 weeks
measure: Key time points when BP should be monitored post birth
timeFrame: 10 weeks
Other outcomes:
Locations:
city: London Borough Of Wandsworth
country: United Kingdom
facility: St. George's University NHS Hopsitals
state: London
Study officials:
References:
citation: 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.