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Trial record 3 of 31 for:    "Preeclampsia/eclampsia 1" | "Antihypertensive Agents"

Self-management of Postnatal Anti-hypertensive Treatment: a Trial Development Pilot Study (SNAP-HT)

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ClinicalTrials.gov Identifier: NCT02333240
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : November 30, 2016
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

New-onset raised blood pressure (BP) affects about one in ten pregnancies. For some women, raised BP is an indication of pre-eclampsia: newly arising high blood pressure in pregnancy combined with protein leaking into the urine. After birth, women's BP remains elevated for a period of time, but in most cases returns to normal over 2-12 weeks. During this period medication needs to be adjusted to achieve the correct control. Research suggests that better BP control during this period is associated with improved long-term health outcomes. The investigators would like to find out whether home BP monitoring, and self-adjustment of medications according to an individualised protocol, could improve BP control and patient satisfaction.

This pilot study has been set up to inform the planning of a large-scale multi-centre randomised controlled trial by testing the feasibility of the protocol. The investigators want to increase our experience of applying this management approach in this subset of patients; to select the most appropriate primary outcome measure and to estimate the effect size of this intervention; to assess recruitment potential; and to evaluate feasibility of coordinating this trial across several centres. The primary objective of the large-scale trial will be to determine whether the self-management approach can improve BP control in women with medicated hypertensive disorders of pregnancy in the postnatal period.

Women recruited to the study will be randomly assigned to one of two groups: self-management or usual care. Participants allocated to 'usual care' will have their BP monitored and medication adjusted by their general practitioner (GP) and midwife as normal. Participants allocated to the 'self-management' group will use a home BP monitor daily following discharge from hospital after birth. They will be provided with an individualised schedule for gradually decreasing their medication(s) in line with their BP readings. Women will be followed up for 6 months.


Condition or disease Intervention/treatment Phase
Pre-Eclampsia Hypertension, Pregnancy-Induced Other: Self-management of postnatal anti-hypertensive treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-management of Postnatal Anti-hypertensive Treatment: a Trial Development Pilot Study
Study Start Date : April 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual care

Women randomised to usual care will have their blood pressure monitored by their community midwife, and will have their anti-hypertensive medication adjusted by their general practitioner. There will be no intervention in this group.

All women will be followed up at ten days, four and six weeks, then three and six months postpartum and have their blood pressure measured by one of the study team.

Experimental: Self-management
Self-management of postnatal anti-hypertensive treatment. Women will be provided with, and taught to use, a validated home blood pressure monitor, and perform daily BP readings. When treatment is discontinued we will ask them to continue daily BP measurements for 1 week. Provided these are <140/90 mmHg they will be asked to check their BP weekly for the remainder of the trial period. The self-monitoring BP data will be collated centrally through the use of a smart phone app or SMS based system. This service will respond to participants regarding the level of their BP and what action is required. Women in the self-management group will have an individualised medication adjustment schedule developed by the research team in conjunction with the participant's obstetric team.
Other: Self-management of postnatal anti-hypertensive treatment
Daily use of a validated home blood pressure monitor in conjunction with an individualised medication adjustment schedule to adjust anti-hypertensive medications in line with blood pressure readings.




Primary Outcome Measures :
  1. Feasibility: recruitment rate [ Time Frame: 13 months from trial start date (end of the recruitment period) ]
    Number of participants randomised / number of consenting participants Number of participants randomised / number of potential participants approached

  2. Feasibility: retention rate [ Time Frame: Up to 19 months from trial start date ]
    Number of participants completing trial follow up / number of participants randomised

  3. Feasibility: attrition rate [ Time Frame: Up to 19 months from trial start date ]
    Number of participants lost to follow-up or withdrawn / number of participants randomised

  4. Feasibility: compliance rate [ Time Frame: Up to 19 months from trial start date ]
    Number of study visits attended / total number of intended study visits


Secondary Outcome Measures :
  1. Mean systolic blood pressure at follow up visits [ Time Frame: 6 months from baseline visit ]
    Mean of systolic blood pressure at day 10, 4 weeks, 6 weeks, 12 weeks and 26 weeks postpartum Number of blood pressure readings in target range 'Time to event': number of urgent visits, and timing of these, to GP or hospital requiring medication increase due to BP > 150/100, or medication decrease due to BP < 100 systolic

  2. Mean diastolic blood pressure at follow up visits [ Time Frame: 6 months from baseline visit ]
    Mean of diastolic blood pressure at day 10, 4 weeks, 6 weeks, 12 weeks and 26 weeks postpartum Number of blood pressure readings in target range 'Time to event': number of urgent visits, and timing of these, to GP or hospital requiring medication increase due to BP > 150/100, or medication decrease due to BP < 100 systolic

  3. Change in participant self-assessed quality of life from screening visit to 6 week follow up visit [ Time Frame: 6 weeks from baseline visit ]
    Change in EQ-5D-5L health questionnaire results from screening visit to 6 week follow up Structured interviews (participants) EQ-5D-5L health questionnaire results Structured interviews (participants)

  4. Change in participant self-assessed quality of life from screening visit to 6 month follow up visit [ Time Frame: 6 months from baseline visit ]
    Change in EQ-5D-5L health questionnaire results from screening visit to 6 month follow up Structured interviews (participants) EQ-5D-5L health questionnaire results Structured interviews (participants)

  5. Change in cardio-ankle vascular index from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
    Cardio-ankle vascular index

  6. Change in pulse wave velocity from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
    Radial arterial tonometry

  7. Change in capillary density from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
    Microvascular changes: capilloroscopy

  8. Change in laboratory values from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
    Haemoglobin, platelets, creatinine, alanine transferase, uric acid, lipid profile, insulin, glucose and novel markers of pre-eclampsia

  9. Safety (reporting adverse events and side effects) [ Time Frame: 6 months from baseline visit ]
    Reporting of serious adverse events Reporting of side effects


Other Outcome Measures:
  1. To explore percentage time spent in range as a marker for blood pressure control in this setting. (percentage time spent in target BP range) [ Time Frame: 6 months from baseline visit ]
    Assess percentage time spent in target BP range in both groups, and use the home monitoring data from the intervention arm to explore the validity of this measure and the relationship between the trial blood pressure readings taken at two time points

  2. Setting BP thresholds for future trials (Difference between home and clinic BP recordings) [ Time Frame: 6 months from baseline visit ]
    Difference between home and clinic BP recordings



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Female, aged 18 years or above.
  • Women with gestational hypertension (new-onset BP > 140/90mmHg) or pre-eclampsia (new onset BP > 140/90mmHg and significant proteinuria > 300mg/24hr), prior to their discharge from hospital post-delivery.
  • Require antihypertensive medication during pregnancy, which needs to continue in the postpartum period.

Exclusion Criteria:

  • Hypertension prior to pregnancy.
  • Poor English language skills.
  • More than three anti-hypertensive agents at discharge from hospital postpartum.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333240


Locations
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United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom, RG1 5AN
Northampton General Hospital NHS Trust
Northampton, Northamptonshire, United Kingdom, NN1 5BD
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Stoke Mandeville Hospital
Aylesbury, United Kingdom, HP21 8AL
Horton General Hospital
Banbury, United Kingdom, OX16 9AL
Sponsors and Collaborators
University of Oxford
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Alexandra E Cairns, BMBCh MA Nuffield Department of Primary Care Health Sciences, University of Oxford

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02333240     History of Changes
Other Study ID Numbers: 10959
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Oxford:
Pregnancy
Postnatal Care
Blood Pressure Monitoring, Home
Self Care
Pregnancy Complications, Cardiovascular
Qualitative Research
Antihypertensive Agents
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Antihypertensive Agents