title: Postpartum physiology, psychology and paediatric follow up study (P4 Study) - Study protocol.
abstract: BACKGROUND
  Women who have had hypertension in pregnancy are at greater risk of long term cardiovascular disease (CVD). Little is known about their cardiovascular risk postpartum or the effects on the woman's mental health and the outcomes of their infants. In this project we will study the physiological and psychological health of women and the physical health and development of their infants six months, two years and five years after birth. We will establish normal blood pressure (BP) and metabolic function for women who were normotensive in pregnancy and use these to assess women who had gestational hypertension (GH) or preeclampsia (PE).
  
  
  METHODS
  Women will be asked to participate if they have given birth in the preceding six months. They will be excluded if they had diabetes, hypertension, renal or other serious maternal disease prior to pregnancy or congenital anomaly in the pregnancy. We will recruit 292 women who were normotensive and their babies, 100 who had GH and 100 who had PE and their babies. They will be assessed at six months, two and five years after birth. At each assessment mothers will have their blood pressure (BP) assessed peripherally with a liquid crystal sphygmomanometer and 24h ambulatory blood pressure monitoring (ABPM), and centrally with non-invasive applanation tonometry. Additional physiological testing will include: body composition; energy balance; vascular compliance; cardiac function; liver and renal function, lipids and biochemistry; glucose and insulin; and urinalysis. Psychological status will be assessed with validated self-report questionnaires for depression, anxiety, post-traumatic stress disorder (PTSD) and mother-infant bonding. The babies will have a medical examination by a paediatrician at each assessment. Their behavioural development will be assessed with an Ages and Stages Questionnaire completed by their mother at each assessment and a developmental assessment by a child psychologist at two and five years.
  
  
  CONCLUSIONS
  This study will re-define normal BP and other physiological parameters for young parous women thereby permitting a more sensitive assessment of post-partum BP and other cardiovascular risk markers in women who have had GH or PE. It will also determine the extent, if any, of psychological disorders in these women and developmental or other concerns in their babies.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry Number: ACTRN12613001260718.
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of NSW, Randwick, NSW 2031, Australia. Electronic address: Greg.Davis@health.nsw.gov.au.
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Davis
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of Technology Sydney, Broadway, Ultimo, NSW 2007, Australia. Electronic address: Lynne.Roberts2@health.nsw.gov.au.
authors.forename: Lynne
authors.initials: L
authors.lastname: Roberts
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of NSW, Randwick, NSW 2031, Australia. Electronic address: g.mangos@unsw.edu.au.
authors.forename: George
authors.initials: G
authors.lastname: Mangos
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of NSW, Randwick, NSW 2031, Australia. Electronic address: Amanda.Henry@unsw.edu.au.
authors.forename: Amanda
authors.initials: A
authors.lastname: Henry
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of NSW, Randwick, NSW 2031, Australia. Electronic address: Franziska.Pettit@health.nsw.gov.au.
authors.forename: Franziska
authors.initials: F
authors.lastname: Pettit
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of NSW, Randwick, NSW 2031, Australia. Electronic address: a.osullivan@unsw.edu.au.
authors.forename: Anthony
authors.initials: A
authors.lastname: O'Sullivan
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of Technology Sydney, Broadway, Ultimo, NSW 2007, Australia. Electronic address: Caroline.Homer@uts.edu.au.
authors.forename: Caroline S E
authors.initials: CS
authors.lastname: Homer
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of NSW, Randwick, NSW 2031, Australia; Sydney Children's Hospital, Randwick, NSW 2031, Australia. Electronic address: m.craig@unsw.edu.au.
authors.forename: Maria
authors.initials: M
authors.lastname: Craig
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of NSW, Randwick, NSW 2031, Australia; Black Dog Institute, Randwick, NSW 2031, Australia. Electronic address: s.harvey@unsw.edu.au.
authors.forename: Samuel B
authors.initials: SB
authors.lastname: Harvey
authors.affiliation: St George Hospital, Gray Street, Kogarah, NSW 2217, Australia; University of NSW, Randwick, NSW 2031, Australia. Electronic address: m.brown@unsw.edu.au.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Brown
mesh_terms: D001007:Anxiety / Q000209:etiology; D001794:Blood Pressure; D001808:Blood Vessels / Q000502:physiology; D001823:Body Composition; D016022:Case-Control Studies; D002652:Child Behavior; D002657:Child Development; D002675:Child, Preschool; D003187:Compliance; D003863:Depression / Q000209:etiology; D005260:Female; D006801:Humans; D046110:Hypertension, Pregnancy-Induced / Q000503:physiopathology* / Q000523:psychology*; D007223:Infant; D007668:Kidney / Q000502:physiology; D008099:Liver / Q000502:physiology; D049590:Postpartum Period; D011225:Pre-Eclampsia / Q000503:physiopathology / Q000523:psychology; D011247:Pregnancy; D011446:Prospective Studies; D012107:Research Design; D013313:Stress Disorders, Post-Traumatic / Q000209:etiology; D059289:Vascular Stiffness; D016276:Ventricular Function
keywords: Cardiovascular risk; Infant outcomes; Postnatal depression; Postpartum risk; Preeclampsia