Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001260718
Ethics application status
Approved
Date submitted
14/11/2013
Date registered
18/11/2013
Date last updated
24/03/2024
Date data sharing statement initially provided
28/06/2019
Date results provided
10/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A five year postpartum follow-up study of the physical and mental health of women, and the health and development of their babies, in women who had high blood pressure in pregnancy and those who did not.
Scientific title
Postpartum Physiology, Psychology, and Paediatric follow-up comparison study for women who had hypertension in pregnancy and those who did not
Secondary ID [1] 283587 0
Nil known
Universal Trial Number (UTN)
U1111-1150-3137
Trial acronym
P4 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension in pregnancy ie. Gestational Hypertension and Preeclampsia 290494 0
Blood pressure 290495 0
Mental health eg. depression, anxiety 290496 0
Baby health and development 290497 0
Condition category
Condition code
Cardiovascular 290890 290890 0 0
Hypertension
Mental Health 290924 290924 0 0
Depression
Reproductive Health and Childbirth 290925 290925 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The physical and mental health of women who had hypertension in pregnancy, and the health and development of their babies, will be recorded at six months, two years and five years postpartum.
Intervention code [1] 288274 0
Not applicable
Comparator / control treatment
The physical and mental health of women who did not have hypertension in pregnancy, and the health and development of their babies, will be recorded at six months, two years and five years postpartum for comparison
Control group
Active

Outcomes
Primary outcome [1] 290885 0
A difference of 7mmHg in diastolic blood pressure. This is measured using 24hour ambulatory blood pressure monitoring where the device records blood pressure every 30minutes over a 24hour period.
Timepoint [1] 290885 0
At six months, two years and five years postpartum
Primary outcome [2] 290886 0
Edinburgh Depression Scale score of >12
Timepoint [2] 290886 0
At six months, two years and five years postpartum
Secondary outcome [1] 305538 0
Health and development of child. The health of the child is assessed by a paediatrician at six months of age, two years of age and again at five years of age. The development of the child is assessed using the Ages and Stages Questionnaire at six months (completed by the parent/caregiver), two years and five years of age. A Bayley-III at two years of age done by a Child Developmental Psychologist.
Timepoint [1] 305538 0
At six months of age, two years of age, and five years of age

Eligibility
Key inclusion criteria
Women are eligible if they have given birth to a live baby in the past six months and have a good understanding of written and spoken english. The babies born to these eligible women will also be eligible.
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women are ineligible if they had diabetes, hypertension, renal or other serious maternal disease prior to the pregnancy, had a multiple pregnancy, their baby was born with a congenital abnormality or they are pregnant again

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study will be powered on the proportion of 24 h mean diastolic
blood pressure (DBP) readings two or more standard deviations
(SD) above the mean for women who were normotensive in
pregnancy. In preliminary data on normotensive women at six
months postpartum, 4/98 (4%) had 24 h average DBP readings
>2 SD above the mean, as expected, compared to 5/22 (23%) hypertensive
women. Based on these data, 56 women will be required in
each group, with a 95% confidence level and 85% power. Sample
size assessment is based on the hypertensive group as a whole but
current data suggests that the women who had PE and GH have
similar rates of elevated average 24 h DBP.
We plan to recruit 292 women who were normotensive in pregnancy
in order to construct a 95% reference range for normal
values in a postpartum population. One hundred women who had
GH and 100 who had PE in pregnancy will be recruited. This will
allow for an estimated 15% loss to follow up and women who will
be pregnant again prior to two and five year follow ups.Women who
have been pregnant again prior to follow up at two and five years
will be analysed on intention-to-treat with subgroup analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/07/2013
Actual
16/07/2013
Date of last participant enrolment
Anticipated
28/02/2019
Actual
13/06/2019
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
492
Accrual to date
Final
415
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1717 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 7559 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 288272 0
Hospital
Name [1] 288272 0
St George Hospital
Country [1] 288272 0
Australia
Funding source category [2] 300235 0
Charities/Societies/Foundations
Name [2] 300235 0
St George and Sutherland Medical Research Foundation
Country [2] 300235 0
Australia
Primary sponsor type
Individual
Name
A/Prof Gregory Davis
Address
Women's Health
Level 2 Prichard Wing
St George Hospital
Gray St
Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 286987 0
None
Name [1] 286987 0
Address [1] 286987 0
Country [1] 286987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290169 0
South Eastern Sydney Local Health District (Northern Sector) HREC
Ethics committee address [1] 290169 0
Ethics committee country [1] 290169 0
Australia
Date submitted for ethics approval [1] 290169 0
30/10/2012
Approval date [1] 290169 0
05/03/2013
Ethics approval number [1] 290169 0
HREC/12/POWH/395

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44238 0
A/Prof Gregory Davis
Address 44238 0
Women's Health
Level 2 Prichard Wing
St George Hospital
Gray Street
Kogarah NSW 2217
Country 44238 0
Australia
Phone 44238 0
+61 2 91133547
Fax 44238 0
+61 2 91133901
Email 44238 0
[email protected]
Contact person for public queries
Name 44239 0
Lynne Roberts
Address 44239 0
1 South Maternity
St George Hospital
Gray Street
Kogarah NSW 2217
Country 44239 0
Australia
Phone 44239 0
+61 2 91132117
Fax 44239 0
+61 2 91133642
Email 44239 0
[email protected]
Contact person for scientific queries
Name 44240 0
Gregory Davis
Address 44240 0
Women's Health
Level 2 Prichard Wing
St George Hospital
Gray Street
Kogarah NSW 2217
Country 44240 0
Australia
Phone 44240 0
+61 2 91133547
Fax 44240 0
+61 2 91133901
Email 44240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified participant data collected from the index pregnancy, 6 month visit, 2 year visit and 5 year visit may be shared upon reasonable request
When will data be available (start and end dates)?
Data will be available at the end of each stage of the Study - 6 month stage has finished so is available now, 2 year stage is due for completion January 2021 and 5 year stage is due for completion Jan 2024. There is no end date for when data will be available.
Available to whom?
Data will be available only to researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of the Research Team.
Available for what types of analyses?
To achieve the aims in the approved proposals
How or where can data be obtained?
Researchers requesting to use study data will need to approach the Research Team with their proposal before the Team will consider their request. Please contact the PI Prof Greg Davis at [email protected] to have a request considerd by the Research Team


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDepression, anxiety and posttraumatic stress disorder six months following preeclampsia and normotensive pregnancy: a P4 study.2022https://dx.doi.org/10.1186/s12884-022-04439-y
EmbaseMental health in the two years following hypertensive and normotensive pregnancy: The Postpartum, Physiology, Psychology and Paediatric follow-up (P4) cohort study.2024https://dx.doi.org/10.1016/j.preghy.2023.12.008
N.B. These documents automatically identified may not have been verified by the study sponsor.