Prospective Study of Stillbirth Genetics

Full Study Name

Prospective Study of Stillbirth Genetics

Local Principal Investigator

Dr Siddharth Banka

Study Status

recruiting

Main Aims

Primary objectives

  1. To evaluate the utility of array-CGH to detect CNVs and UPD (pilot phase and main phase) in placentas from cases of unexplained stillbirth (pilot phase and main phase).
  2. To evaluate the utility of NGS in cases of cases of unexplained stillbirth (main phase only).

Secondary objectives

  1. Gather evidence for the hypothesis (pilot phase only).
  2. Gather data to inform the required scale and duration of the main phase to obtain sufficient statistical power (pilot phase only).
Inclusion Criteria
  • Possible placental or fetal genetic cause of stillbirth.
  • Routine examination and testing has not identified a clear cause of stillbirth.
  • Previous consent for use of tissue for genetic research studies (taken before post-mortem).
  • Adequate amount of stored DNA from placental and fetal tissue.
Exclusion Criteria
  • Unlikely underlying genetic cause of stillbirth.
  • Routine examination and testing has already identified a clear cause of stillbirth.
  • Consent not given for use of tissue for genetic research studies (taken before post-mortem).
  • Insufficient or poor quality DNA from placental or fetal tissue.
  • Either parent is a vulnerable adult or below 16 years of age.
Open Sites

Saint Mary’s Hospital, Manchester

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