None listed
Conditions
Brief summary
Hypertensive disorders of pregnancy (HDP) complicate 1 in 10 Australian pregnancies, and are associated with an increased medium to long term risk of cardiovascular disease and death, including heart attacks and stroke. However, few initiatives currently target women after HDP to improve their long term health. This multicentre study will assess outcomes of 3 interventions in women being managed after an HDP pregnancy: A. Optimised usual care (CONTROL): Follow-up in primary healthcare and supplied written information B. Brief Education Intervention: One-off individualised risk assessment and education “Brief Intervention” at a specialised hospital postpartum clinic C. Extended Lifestyle Intervention: an individualised “Extended Intervention” comprising a 6 month healthy lifestyle program, commencing six months postpartum 480 women will be randomised to one of the 3 interventions 6 months after HDP, with outcome assessment at 12 months (and plan for 2 and 3 year follow-through assessment). Outcomes: 1) Lifestyle behaviour and/or blood pressure (BP) change 2) Cost-effectiveness and patient acceptability 3) Infant growth trajectory 4) Non-invasive maternal measures of vascular structure and function
Interventions
At 6 months postpartum (pp) all participants (women after preeclampsia, gestational hypertension, or chronic hypertension) complete validated questionnaires: NSW Population Health Survey (by telephone), Infant Feeding behaviours, Health-related Quality of Life (EQ-5D-5L), Ages and Stages, Edinburgh Postnatal Depression Score, Generalised Anxiety Disorder and a study designed maternal and infant health questionnaire about health since the birth (hard copy or online). Pregnancy, labour, birth and infant details will be recorded from the hospital maternity database. Blood and urine testing will be done and repeated at 12 months pp. After completion of baseline questionnaires, women are randomised into one of 3 groups with interventions as below. Optimised Usual Care (Group 1): • report their weight, height, and waist circumference to the research staff • sent package containing readily available information about cardiovascular health after hypertensive disorder of pregnancy (HDP). This information includes: 1. The Heart Foundation infographic titled 'Did you have high blood pressure during pregnancy?'(www.heartfoundation.org.au), 2. The NSW Get Healthy Service (GHS) a free service of phone call counselling to work towards healthy lifestyle changes (www.gethealthynsw.com.au) 3. The link to the 'My Baby Now' app which is free and available on IoS and android phones. This app offers information regarding the baby's development and nutrition advice through to 9-12 months of age. • visit their GP with their infant at 6 months pp for BP check, weight and their infant’s weight, height and head circumference. GP/medical centre will be sent an information package to assist with this visit. This package will contain an explanatory cover letter, correspondence from the pregnancy/birth care including the hospital discharge summary, the Heart Foundation Information for GPs titled 'Hypertensive Disorders of Pregnancy and Cardiovascular Disease: A guide for GPs' (this consists of two brochures: General Facts and Postpartum Assessment, both freely available on the Heart foundation Website), a copy of the information pack given to the woman (see above) and a copy of the woman's signed study consent form. Details of the GP visit will be sent to the research staff to complete data collection. A reminder phone will be made to the participants regarding booking this appointment with their GP/medical centre. Brief Education Intervention (Group 2): • attend hospital with their infant at 6 months pp for maternal measures: peripheral and central BP, height, weight, waist circumference, body composition, and infant measures: weight, length, head and abdominal circumference, blood pressure • a single 30 minute consultation with an obstetric medicine physician, who will review the personal history and examination findings, educate regarding long-term health implications of HDP, and address cardiovascular risk by offering advice on lifestyle and behavioural change such as quit smoking, exercise and healthy diet. • see a dietitian for a single 30 minute appointment to review of diet and physical activity, infant’s feeding patterns, and discussion on healthy eating and physical activity. A reminder text message will be sent a few days prior to theses appointments to remind the participant of the appointment. Data from these visits will be sent to the researcher for data collection and entry into database. Extended lifestyle intervention (Group 3) In addition to the intervention for Group 2, research staff will enroll Group 3 participants in the NSW Get Healthy Service (GHS). GHS will then provide, over a 6 month period, up to 13 coaching calls that include initial goal setting and then working towards lifestyle behaviour change goals during program enrollment. A follow-up phone call and text message will be made by trial research staff 2-3 weeks after enrollment into GHS to check that contact has been made between GHS and the participant and that the participant has commenced with the GHS program. Adherence to the GHS will be assessed at the 12 month follow-up visit by the GHS staff who will liaise with study researchers. GHS staff will use the Service records to report on which GHS clients participated in the trial (whether in Group 1, 2, or 3), provide data on whether participants completed (a) initial GHS process (b) full 6-month GHS service (c) for those trial participants who initiated but did not complete, point of GHS termination and any know reason. Semi structured interviews will be conducted with women from all groups between the 6 and 12 month visits. These interviews will explore the barriers and enablers to adopting healthy eating and physical activity behaviours post-partum and women will be asked their views of the intervention to better understand their engagement. All women will be invited to participate via a question at the end of the women’s 6 month survey and we will purposefully sample from each of the groups to ensure that views are captured about each arm of the intervention.
Sponsors
Study design
Eligibility
Inclusion criteria
Have given birth at one of the study hospitals during the study period. The index pregnancy was complicated by a hypertensive disorder of pregnancy: preeclampsia (PE), gestational hypertension (GH), chronic hypertension ± superimposed PE
Exclusion criteria
Plan to move out of study area/known unavailability to follow-up during study period Active severe mental health condition or developmental disability precluding informed consent.