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Risk factors for Stillbirth: A multi-centre case control study

Risk factors for Stillbirth: A multi-centre case control study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12609000990224
Acronym
SBS STUDY
Enrollment
295
Registered
2009-11-17
Start date
2006-01-01
Completion date
2011-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

stillbirth cases will be recorded until 100 cases are recruited from January 2006.

Sponsors

Royal Prince Alfred Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
16 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

cases: stillbirth infants born >= 32 weeks gestational age singleton pregnancy controls: matched to case by Estimated Date of Confinement (EDC) and hospital

Exclusion criteria

cases and controls: known congential or chromosomal abnormality aboriginal or torres straight island mother

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026