ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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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

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

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.

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

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]

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]

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]

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]

fetal movements meausred by a fetal movement questionaire. 8 qualitative questions asking a range of differenent questions relating to fetal movements

Timepoint [2]

recorded during the semi- structed interview (antenatally for controls and ranging from 1-6 weeks after birth for cases)

Secondary outcome [1]

Obstetric history and other lifestyle factors

Timepoint [1]

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]

Charities/Societies/Foundations

Name [1]

The Stillbirth Foundation

Address [1]

P O Box 9
Willoughby
NSW 2068

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council

Address [2]

Level 1, 16 Marcus Clarke Street
Canberra ACT 2601

Country [2]

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]

University

Name [1]

The University of Sydney

Address [1]

The University of Sydney
NSW 2006
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Health (Hawkesbury) Human Research Ethics Committee

Ethics committee address [1]

The Research Business Unit
Level 2, Building 51, 
Royal North Shore Hospital 
St Leonards 
NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/08/2005

Approval date [1]

30/12/2005

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Adrienne Gordon

Address

RPA Newborn Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 95156778

Fax

adrienne.gordon@email.cs.nsw.gov.au

Contact person for scientific queries

Name

Adrienne Gordon

Address

RPA newborn care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 95156778

Fax

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

Source	Title	Year of Publication	DOI
Embase	Sleep position, fetal growth restriction, and late-pregnancy stillbirth: The sydney stillbirth study.	2015	https://dx.doi.org/10.1097/AOG.0000000000000627

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically