Self-management of Postnatal Anti-hypertensive Treatment: a Trial Development Pilot Study

NCT02333240 | Completed DMC

• 1 other identifier: 10959
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 5

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.

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Keywords

Pregnancy; Postnatal Care; Blood Pressure Monitoring, Home; Self Care; Pregnancy Complications, Cardiovascular; Qualitative Research; Antihypertensive Agents

Outcome Measures

Primary Outcomes (4)

• Feasibility: recruitment rate

  Number of participants randomised / number of consenting participants Number of participants randomised / number of potential participants approached

  13 months from trial start date (end of the recruitment period)

• Feasibility: retention rate

  Number of participants completing trial follow up / number of participants randomised

  Up to 19 months from trial start date

• Feasibility: attrition rate

  Number of participants lost to follow-up or withdrawn / number of participants randomised

  Up to 19 months from trial start date

• Feasibility: compliance rate

  Number of study visits attended / total number of intended study visits

  Up to 19 months from trial start date

Secondary Outcomes (9)

• Mean systolic blood pressure at follow up visits

  6 months from baseline visit

• Mean diastolic blood pressure at follow up visits

  6 months from baseline visit

• Change in participant self-assessed quality of life from screening visit to 6 week follow up visit

  6 weeks from baseline visit

• Change in participant self-assessed quality of life from screening visit to 6 month follow up visit

  6 months from baseline visit

• Change in cardio-ankle vascular index from baseline to 3 months

  3 months from baseline visit

Other Outcomes (2)

• To explore percentage time spent in range as a marker for blood pressure control in this setting. (percentage time spent in target BP range)

  6 months from baseline visit

• Setting BP thresholds for future trials (Difference between home and clinic BP recordings)

  6 months from baseline visit

Study Arms (2)

Usual care

NO INTERVENTION

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.

Self-management

EXPERIMENTAL

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

Interventions

Self-management of postnatal anti-hypertensive treatment OTHER

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.

Self-management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (5)

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG1 5AN, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, Northamptonshire, NN1 5BD, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Stoke Mandeville Hospital

Aylesbury, HP21 8AL, United Kingdom

Location

Horton General Hospital

Banbury, OX16 9AL, United Kingdom

Location

Related Publications (32)

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  PMID: 34176288 DERIVED

• Cairns AE, Tucker KL, Crawford C, McManus RJ, Powell J. Implementing self-management: a mixed methods study of women's experiences of a postpartum hypertension intervention (SNAP-HT). Trials. 2020 Jun 9;21(1):508. doi: 10.1186/s13063-020-04394-z.

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  PMID: 29967037 DERIVED

Related Links

• NICE Clinical Guideline 107 (Hypertension in pregnancy)

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications, Cardiovascular

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexandra E Cairns, BMBCh MA

  Nuffield Department of Primary Care Health Sciences, University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: January 7, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)