Background: Identification of the causes of stillbirth is critical to the primary prevention of stillbirth and to the provision of optimal care in subsequent pregnancies. A wide variety of investigations are available, but there is currently no consensus on the optimal approach. Given their cost and potential to add further emotional burden to parents, there is a need to systematically assess the effect of these interventions on outcomes for parents, including psychosocial outcomes, economic costs, and on rates of diagnosis of the causes of stillbirth.
Objectives: To assess the effect of different tests, protocols or guidelines for investigating and identifying the causes of stillbirth on outcomes for parents, including psychosocial outcomes, economic costs, and rates of diagnosis of the causes of stillbirth.
Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 May 2017).
Selection criteria: We planned to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. We planned to include studies published as abstract only, provided there was sufficient information to allow us to assess study eligibility. We planned to exclude cross-over trials.Participants included parents (including mothers, fathers, and partners) who had experienced a stillbirth of 20 weeks' gestation or greater.This review focused on interventions for investigating and identifying the causes of stillbirth. Such interventions are likely to be diverse, but could include:* review of maternal and family history, and current pregnancy and birth history;* clinical history of present illness;* maternal investigations (such as ultrasound, amniocentesis, antibody screening, etc.);* examination of the stillborn baby (including full autopsy, partial autopsy or noninvasive components, such as magnetic resonance imaging (MRI), computerised tomography (CT) scanning, and radiography);* umbilical cord examination;* placental examination including histopathology (microscopic examination of placental tissue); and* verbal autopsy (interviews with care providers and support people to ascertain causes, without examination of the baby).We planned to include trials assessing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth, compared with the absence of a test, protocol or guideline, or usual care (further details are presented in the Background, see Description of the intervention).We also planned to include trials comparing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth with another, for example, the use of a limited investigation protocol compared with a comprehensive investigation protocol.
Data collection and analysis: Two review authors assessed trial eligibility independently.
Main results: We excluded five studies that were not RCTs. There were no eligible trials for inclusion in this review.
Authors' conclusions: There is currently a lack of RCT evidence regarding the effectiveness of interventions for investigating and identifying the causes of stillbirth. Seeking to determine the causes of stillbirth is an essential component of quality maternity care, but it remains unclear what impact these interventions have on the psychosocial outcomes of parents and families, the rates of diagnosis of the causes of stillbirth, and the care and management of subsequent pregnancies following stillbirth. Due to the absence of trials, this review is unable to inform clinical practice regarding the investigation of stillbirths, and the specific investigations that would determine the causes.Future RCTs addressing this research question would be beneficial, but the settings in which the trials take place, and their design, need to be given careful consideration. Trials need to be conducted with the utmost care and consideration for the needs, concerns, and values of parents and families. Assessment of longer-term psychosocial variables, economic costs to health services, and effects on subsequent pregnancy care and outcomes should also be considered in any future trials.
Conflict of interest statement
Aleena M Wojcieszek: is an Associate Investigator for a National Health and Medical Research Council (NHMRC) Centre of Research Excellence in stillbirth and member of the International Stillbirth Alliance Scientific Advisory Committee executive.
Emily Shepherd: none known.
Philippa Middleton: is a chief investigator for an NHMRC Centre of Research Excellence in stillbirth.
Glenn Gardener: is an associate investigator for an NHMRC Centre of Research Excellence in stillbirth and serves as an unpaid board member for the International Stillbirth Alliance. He was also PI on two NHMRC funded studies in the area of stillbirth (not eligible for inclusion in this review).
David A Ellwood: has received sitting fees from the Australian Medical Council but this work is not related to this Cochrane Review; has received payment for providing expert witness reviews for medico‐legal cases unrelated to the topic under review; is a chief investigator for an NHMRC Centre for Research Excellence in stillbirth.
Elizabeth M McClure: none known.
Katherine J Gold: serves as an unpaid board member for the International Stillbirth Alliance.
Teck Yee Khong: has received fees for expert testimony for plaintiffs and defence in cases related to cerebral palsy and stillbirth; royalties from Springer, London (publishers) in respect of book publication (Fetal and Neonatal Pathology 5th ed); expenses for attending scientific meetings of paediatric pathology societies; and holds shares in one health insurance provider (Medibank) listed in the Australian Stock Exchange.
Robert M Silver: is conducting NIH sponsored research investigating pregnancy as a window to future maternal health, human placental function and clinical obstetric trials. None of these directly address the work for this report. He is also a member of the International stillbirth Alliance Scientific Research Committee.
Jan Jaap HM Erwich: is chair of a foundation for the organisation of conferences on stillbirth and perinatal death, without a fee; received funding across 2002‐2006 to investigate the causes of stillbirth (not eligible for inclusion in this review).
Vicki Flenady: is the lead investigator of the Centre of Research Excellence in Stillbirth in Australia which received funding from the National Health and Medical Research Council in November 2016. Her salary is part‐funded by the MHMRC through a Career Development Fellowship.
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