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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 pro

Detailed Summary:

Hypertensive disorders of pregnancy (HDP) affect 3-15% of pregnancies. Gestational hypertension is new-onset blood pressure (BP) > 140/90mmHg after 20 weeks gestation. Pre-eclampsia is gestational hypertension with proteinuria (> 300mg / 24 hours). HDP are the second commonest direct cause of maternal death in the UK and USA, and the leading cause of maternal death in Latin America and the Caribbean.

HDP persist postpartum, and complications can occur during this time. Most women with HDP will be treatment-free by 3 months postpartum. This rapidly changing BP, with shifting medication requirement, poses a challenge in terms of how best to manage this down-titration. Both NICE guidelines and a Cochrane review highlight that few clinical studies have addressed the management of BP postpartum. In practice clinical care is to continue antepartum anti-hypertensive medication and monitor BP in the community with a focus on prevention of over-treatment.

Approximately 30% of eclamptic seizures occur postpartum: studies suggest that half occur more than 48 hours after birth. A case series of patients who sustained a stroke in association with HDP, showed that more than half occurred postpartum.

Severity of hypertension in later life may be predicted by BP during the first 6 weeks postpartum. Several retrospective cohort studies and a meta-analysis have suggested that HDP are associated with an increased risk of future cardiovascular disease (CVD) in the mother. The 2011 American Heart Association guidelines for the prevention of CVD in women cite a history of HDP as a major risk factor for CVD, and advocate enquiring about pregnancy complications during the evaluation of CVD risk.

Home BP readings have been shown to be more str
Sponsor: University of Oxford

Current Primary Outcome:

• 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
• Feasibility: retention rate [ Time Frame: Up to 19 months from trial start date ]
  Number of participants completing trial follow up / number of participants randomised
• 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
• Feasibility: compliance rate [ Time Frame: Up to 19 months from trial start date ]
  Number of study visits attended / total number of intended study visits

Original Primary Outcome:

• Feasibility: recruitment rate [ Time Frame: 9 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
• Feasibility: retention rate [ Time Frame: Up to 15 months from trial start date ]
  Number of participants completing trial follow up / number of participants randomised
• Feasibility: attrition rate [ Time Frame: Up to 15 months from trial start date ]
  Number of participants lost to follow-up or withdrawn / number of participants randomised
• Feasibility: compliance rate [ Time Frame: Up to 15 months from trial start date ]
  Number of study visits attended / total number of intended study visits

Current Secondary Outcome:

• 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
• 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
• 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)
• 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)
• Change in cardio-ankle vascular index from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
  Cardio-ankle vascular index
• Change in pulse wave velocity from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
  Radial arterial tonometry
• Change in capillary density from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
  Microvascular changes: capilloroscopy
• 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
• Safety (reporting adverse events and side effects) [ Time Frame: 6 months from baseline visit ]
  Reporting of serious adverse events Reporting of side effects

Original Secondary Outcome:

• 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
• 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
• 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)
• 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)
• Change in cardio-ankle vascular index from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
  Cardio-ankle vascular index
• Change in cardio-ankle vascular index from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
  Radial arterial tonometry
• Change in capillary density from baseline to 3 months [ Time Frame: 3 months from baseline visit ]
  Microvascular changes: capilloroscopy
• 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
• Safety (reporting adverse events and side effects) [ Time Frame: 6 months from baseline visit ]
  Reporting of serious adverse events Reporting of side effects

Information By: University of Oxford

Dates:
Date Received: December 15, 2014
Date Started: April 2015
Date Completion:
Last Updated: November 29, 2016
Last Verified: May 2016