Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000990224
Ethics application status
Approved
Date submitted
16/11/2009
Date registered
17/11/2009
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Risk factors for Stillbirth: A multi-centre case control study
Scientific title
Risk factors for Stillbirth: A multi-centre case control study
Universal Trial Number (UTN)
Trial acronym
SBS STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Assess the risk factors for mothers who experience a stillbirth compared to mothers representative of the general population who have a livebirth 252103 0
Investigate the role of undiagnosed viral infections as a possible cause of stillbirth.
The ultimate aim of this study is to focus on finding answers for true unexplained stillbirths to hopefully help prevent them occuring in the future. 252104 0
Condition category
Condition code
Reproductive Health and Childbirth 252309 252309 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 252310 252310 0 0
Antenatal care
Reproductive Health and Childbirth 252311 252311 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
stillbirth cases will be recorded until 100 cases are recruited from January 2006.
Intervention code [1] 241495 0
Not applicable
Comparator / control treatment
live birth controls will be recorded until approximately 200 controls are recruited from January 2006.
Control group
Active

Outcomes
Primary outcome [1] 253180 0
Infection is measured by taking samples of maternal and cord blood, small sample of placenta and umblical cord. Multiplex Polymerase Chain Reaction (PCR) viral testing is conducted.

Placental macro and mirco pathological findings are also conducted.
Timepoint [1] 253180 0
Maternal blood is taking during/ around the time of birth.

Cord blood, piece of placenta and cord is sampled immediately after birth.

The placenta is sent to pathology after birth.
Primary outcome [2] 253281 0
fetal movements meausred by a fetal movement questionaire. 8 qualitative questions asking a range of differenent questions relating to fetal movements
Timepoint [2] 253281 0
recorded during the semi- structed interview (antenatally for controls and ranging from 1-6 weeks after birth for cases)
Secondary outcome [1] 262297 0
Obstetric history and other lifestyle factors
Timepoint [1] 262297 0
Recorded during the semi- structed interview (antenatally for controls and ranging from 1-6 weeks after birth for cases)

Eligibility
Key inclusion criteria
cases:

stillbirth infants born >= 32 weeks gestational age
singleton pregnancy

controls:
matched to case by Estimated Date of Confinement (EDC) and hospital
Minimum age
16 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
cases and controls:

known congential or chromosomal abnormality

aboriginal or torres straight island mother

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2006
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
31/12/2011
Date of last data collection
Anticipated
Actual
31/12/2011
Sample size
Target
300
Accrual to date
Final
295
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243960 0
Charities/Societies/Foundations
Name [1] 243960 0
The Stillbirth Foundation
Country [1] 243960 0
Australia
Funding source category [2] 244022 0
Government body
Name [2] 244022 0
National Health and Medical Research Council
Country [2] 244022 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
RPA Newborn Care
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 251371 0
University
Name [1] 251371 0
The University of Sydney
Address [1] 251371 0
The University of Sydney
NSW 2006
Australia
Country [1] 251371 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244071 0
Northern Sydney Health (Hawkesbury) Human Research Ethics Committee
Ethics committee address [1] 244071 0
The Research Business Unit
Level 2, Building 51,
Royal North Shore Hospital
St Leonards
NSW 2065
Ethics committee country [1] 244071 0
Australia
Date submitted for ethics approval [1] 244071 0
07/08/2005
Approval date [1] 244071 0
30/12/2005
Ethics approval number [1] 244071 0
protocol no: 0605-081M

Summary
Brief summary
The aim of the study is to document risk factors for stillbirths > = 32 weeks gestational age, compared with approximately matched controls (i.e. women expected to have a healthy live born outcome who match the same week of gestational age as the stillbirth mother).

Women who are >= 32 weeks gestational age who have a stillbirth (cases) are matched with 2 women who also are in the same week of gestational age (controls). An identical interview (which is audio taped) is conducted on both cases and controls to assess for risk factors associated with stillbirth. The interviews are then analysed, along with any autopsy or placental histopathology results, to investigate all known or plausible risk factors that can potentially cause stillbirths. The ultimate aim of the study is to focus on finding answers for truly unexplained stillbirths to hopefully help prevent such stillbirths from occurring in the future.

Following delivery and parental consent, both cases and controls will have placental pathology and virology investigations. Additionally, for case study participants who consent to a post-mortem of their stillborn, autopsy investigations will also apply.

For viral investigations, this study is collaborating with a separate research team from Prince of Wales Hospital to investigate the role of undiagnosed viral infections as a possible cause of stillbirths. Samples taken from both cases and controls are examined using a multiplex PCR test to see if there is any evidence of viruses which were previously undiagnosed. The differences in results of any viral infections found in the case group will be compared to that of the control group. The research team from Prince of Wales Hospital has obtained prior ethics approval in 2005 (Sydney South West Area Health Service HREC - RPAH Zone: ethics protocol X04-0135 and South East Sydney & Illawarra Health Service HREC: ethics reference number 04210).

Study type: Prospective case control study

Other research sites: This same study is currently being conducted at Royal Prince Alfred Hospital, Royal North Shore Hospital and North Shore Private Hospital, Mater Hospital (North Sydney), Westmead, Liverpool and Nepean Hospitals.
Trial website
Trial related presentations / publications
Sleep Position, Fetal Growth Restriction, and Late-Pregnancy Stillbirth The Sydney Stillbirth Study (2015) Obstetrics and Gynecology 125(2)
DOI: 10.1097/AOG.0000000000000627
see link:https://journals.lww.com/greenjournal/Fulltext/2015/02000/Sleep_Position,_Fetal_Growth_Restriction,_and.10.aspx
Public notes

Contacts
Principal investigator
Name 30456 0
Address 30456 0
Country 30456 0
Phone 30456 0
Fax 30456 0
Email 30456 0
Contact person for public queries
Name 13703 0
Adrienne Gordon
Address 13703 0
RPA Newborn Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 13703 0
Australia
Phone 13703 0
+61 2 95156778
Fax 13703 0
Email 13703 0
adrienne.gordon@email.cs.nsw.gov.au
Contact person for scientific queries
Name 4631 0
Adrienne Gordon
Address 4631 0
RPA newborn care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 4631 0
Australia
Phone 4631 0
+61 2 95156778
Fax 4631 0
Email 4631 0
adrienne.gordon@email.cs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseSleep position, fetal growth restriction, and late-pregnancy stillbirth: The sydney stillbirth study.2015https://dx.doi.org/10.1097/AOG.0000000000000627
N.B. These documents automatically identified may not have been verified by the study sponsor.