Hypertension in PregnancyNCT05137808
Understanding Blood Pressure Changes After Birth
An observational study of Hypertension in Pregnancy, run by St George's, University of London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Pre-existing hypertension
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St. George's University NHS Hopsitals
Wandsworth, London, SW17 0QT
Elaine Sheehan, Msc, 07535558776, elaine.sheehan@stgeorges.nhs.uk
Sam Hollingworth, 02082666488, sahollin@sgul.ac.uk
About this study
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
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
Read the 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.
- Conditions
- Hypertension in Pregnancy
- Medical subject headings
- Hypertension, Pregnancy-Induced
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of persistent hypertension in postpartum period
Blood Pressure expressed as mmHg at twelve weeks postpartum via 24 hour ambulatory blood pressure monitoring.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start9 May 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137808
- Sponsor's protocol ID
- 2021.0199
- Status last verified
- May 2022
- First submitted
- 16 Nov 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35365547
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05137808
- Acronym / sponsor ID
- 2021.0199
- Conditions
- Hypertension in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Pre-existing hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of persistent hypertension in postpartum period
Time frame: 12 weeks
Blood Pressure expressed as mmHg at twelve weeks postpartum via 24 hour ambulatory blood pressure monitoring.
3 secondary outcomes
Levels of agreement of diastolic and systolic blood pressures between HBPM and ABPM measurements
Time frame: 12 weeks
Identification of women who would benefit from closer BP surveillance
Time frame: 12 weeks
Key time points when BP should be monitored post birth
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 35365547Sheehan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
St. George's University NHS Hopsitals
Wandsworth, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension in Pregnancy, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of persistent hypertension in postpartum period (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.