Self-management of Postnatal Anti-hypertensive Treatment: a Trial Development Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Feasibility: recruitment rate
研究概览
简要总结
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.
详细描述
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 strongly related to indices of target organ damage and have better prognostic value in essential hypertension than office BP measurement. Voluntary home BP monitoring by patients with essential hypertension is becoming increasingly common. The European and American Societies of Hypertension now recommend home BP measurement in the routine diagnosis and monitoring of essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Hypertension prior to pregnancy.
- •Poor English language skills.
- •More than three anti-hypertensive agents at discharge from hospital postpartum.
结局指标
主要结局
Feasibility: recruitment rate
时间窗: 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: compliance rate
时间窗: Up to 19 months from trial start date
Number of study visits attended / total number of intended study visits
Feasibility: attrition rate
时间窗: Up to 19 months from trial start date
Number of participants lost to follow-up or withdrawn / number of participants randomised
Feasibility: retention rate
时间窗: Up to 19 months from trial start date
Number of participants completing trial follow up / number of participants randomised
次要结局
- Change in participant self-assessed quality of life from screening visit to 6 week follow up visit(6 weeks from baseline visit)
- Change in laboratory values from baseline to 3 months(3 months from baseline visit)
- Safety (reporting adverse events and side effects)(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 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)
- Change in pulse wave velocity from baseline to 3 months(3 months from baseline visit)
- Change in capillary density from baseline to 3 months(3 months from baseline visit)
- Mean systolic blood pressure at follow up visits(6 months from baseline visit)