Blood pressure postpartum (BP2) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy

Amanda Henry; Clare Arnott; Angela Makris; Gregory Davis; Annemarie Hennessy; Amanda Beech; Franziska Pettit; Caroline Se Homer; Maria E Craig; Lynne Roberts; Jon Hyett; Georgina Chambers; Oisin Fitzgerald; Megan Gow; Linda Mann; Daniel Challis; Marianne Gale; Annette Ruhotas; Emilee Kirwin; Elizabeth Denney-Wilson; Mark Brown

doi:10.1016/j.preghy.2020.07.001

Blood pressure postpartum (BP²) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy

Pregnancy Hypertens. 2020 Oct:22:1-6. doi: 10.1016/j.preghy.2020.07.001. Epub 2020 Jul 9.

Authors

Amanda Henry¹, Clare Arnott², Angela Makris³, Gregory Davis⁴, Annemarie Hennessy⁵, Amanda Beech⁶, Franziska Pettit⁷, Caroline Se Homer⁸, Maria E Craig⁴, Lynne Roberts⁹, Jon Hyett¹⁰, Georgina Chambers¹¹, Oisin Fitzgerald¹¹, Megan Gow¹², Linda Mann¹³, Daniel Challis¹⁴, Marianne Gale¹⁵, Annette Ruhotas¹⁶, Emilee Kirwin¹⁶, Elizabeth Denney-Wilson¹², Mark Brown⁷

Affiliations

¹ School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.
² The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.
³ Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.
⁴ School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.
⁵ School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.
⁶ Royal Hospital for Women, Randwick, New South Wales, Australia.
⁷ Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.
⁸ Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.
⁹ Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.
¹⁰ Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.
¹¹ National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.
¹² Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
¹³ General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
¹⁴ School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.
¹⁵ New South Wales Ministry of Health, North Sydney, New South Wales, Australia.
¹⁶ Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.

PMID: 32679537
DOI: 10.1016/j.preghy.2020.07.001

Abstract

Objectives: Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP²) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.

Study design: Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.

Main outcome measures: Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.

Secondary outcomes: maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.

Conclusions: BP² will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.

Keywords: Cardiovascular disease; Chronic hypertension; Gestational hypertension; Postpartum; Preeclampsia; Randomised trial.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
Australia
Blood Pressure
Body Mass Index
Cardiovascular Diseases / prevention & control
Double-Blind Method
Female
Healthy Lifestyle*
Humans
Infant
Infant, Newborn
Multicenter Studies as Topic
Patient Education as Topic
Postnatal Care / economics
Postnatal Care / methods*
Pre-Eclampsia / therapy*
Pregnancy
Randomized Controlled Trials as Topic