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PROTOCOLS for STILLBIRTH INVESTIGATION Other Titles in This Series id603888 pdfMachine by Broadgun Software - a great PDF writer! - a great PDF creator! - http://www.pdfmachine.com http://www.broadgun.com PROTOCOLS FOR STILLBIRTH INVESTIGATION Other Titles in this Series HTA Report #1 Interface pressure measurement systems for management of pressure sores HTA Report #2 Posteroventral pallidotomy in Parkinson’s Disease HTA Report #3 In vitro fertilization and embryo transfer For more information contact: as a treatment of infertility HTA Report #4 Assessment of telehealth applications. Health Technology Assessment Version 1 Alberta Heritage Foundation for Medical Research HTA Report #5 Computerized gait analysis in the rehabilitation of children with cerebral palsy and spina bifida Suite 1500 10104 – 103 Avenue HTA Report #6: Evaluation of a telepsychiatry pilot project Edmonton, Alberta Canada T5J 4A7 HTA Report #7 Dynamic posturography in the rehabilitation of stroke, brain injured and amputee patients Tel: 780 423-5727 HTA Report #8 Hyperbaric oxygen treatment in Alberta Fax: 780 429-3509 HTA Report #9 Stereotactic radiosurgery: options for Albertans HTA Report #10 Functional diagnostic imaging in epilepsy HTA Report #11 Quantitative ultrasound for bone density measurement HTA Report #12 Diagnostic tests for vaginosis/vaginitis HTA Report #13 Cord blood transplantation HTA Report #14 Intraocular lenses for uncomplicated senile cataract HTA Report #15 Treatment options for acoustic neuroma HTA Report #16 Functional diagnostic imaging technologies in the assessment of myocardial viability HTA Report #17 Brachytherapy for prostate cancer HTA Report #18 Allogeneic stem cell transplantation HTA Report #19 Low level laser therapy for wound healing Continued on back inside cover HTA Report #36 October 2005 Protocols for Stillbirth Investigation Paula Corabian, Ann Scott HTA Report #36 October 2005 1 HTA Report #36 Protocols for stillbirth investigation Prepared by: Paula Corabian Ann Scott © Copyright Alberta Heritage Foundation for Medical Research, 2005 ISBN 1-894927-24-9 (Print) ISBN 1-894827-25-7 (On-line) ISSN: 1704-1090 (Print) ISSN: 1704-1104 (On-line) Additional information and comments relative to HTA Report are welcome and should be sent to: Director, Health Technology Assessment Alberta Heritage Foundation for Medical Research 1500, 10104 – 103 Avenue NW Edmonton, Alberta, Canada T5J 4A7 Tel: 780-423-5727 Fax: 780-429-3509 www.ahfmr.ab.ca Alberta’s health technology assessment program has been established under the Health Research Collaboration Agreement between the Alberta Heritage Foundation for Medical Research and Alberta Health and Wellness. AHFMR is a member of the International Network of Agencies for Health Technology Assessment (INAHTA) HTA Report # 36 October 2005 i EXECUTIVE SUMMARY Background In Alberta, the rate of stillbirth (defined as the complete expulsion or extraction of a dead fetus at or after 20 weeks of pregnancy or when the fetus weighs at least 500 grams, in which there is no breathing, beating of the heart, pulsation of the umbilical cord, or unmistakable movement of voluntary muscle) was 6.5 per 1000 perinatal deaths in 2000. Each stillbirth may involve unique circumstances and problems, but it is always a devastating experience for families and caregivers. By defining as clearly as possible the cause of death, the information obtained from investigating a stillbirth can help to alleviate the concerns over prenatal events and may have implications for future pregnancies. Formal protocols have been proposed to standardize the investigation in order to ensure that details are not missed and that there is an orderly and systematic search for the cause of death to reduce the number of unexplained stillbirths. Objectives To identify the most appropriate investigative protocol, or component of a protocol, for determining the cause(s) of stillbirth and to identify protocols that have been recommended by health authorities and professional associations both within Canada and worldwide. Results No firm scientific judgment could be made on which is the most appropriate protocol for stillbirth investigation or which components should be considered for the most relevant and efficient investigative protocol. The reviewed evidence (from seven cross-sectional analytic studies) highlights the value of fetal autopsy and placental examinations as integral components of stillbirth investigation in terms of their diagnostic contributions in defining and refining the cause of death and providing additional information: In five retrospective studies, the autopsy findings confirmed the clinical findings in 28.6% to 89% of cases and revealed a change in the diagnosis in 10.2% to 38% of cases. Additional information was obtained at autopsy in 3.9% to 24.3% of cases. The cause of death remained unexplained in up to 40% of cases. Evidence from two prospective studies suggests that placental examination constitutes a necessary complement to fetal autopsy. Placental examination findings confirmed clinical or autopsy findings or both in up to 75% of cases and were diagnostic in 22.7% to 46.3% of cases. However, the cause of death still remained unexplained in up to 12% of stillbirths. HTA Report #36 October 2005 ii Each of the publicly available formal protocols recommends an extensive and comprehensive stillbirth investigation, which should include a wide range of diagnostic tests. However, the protocols differ in terms of the tests recommended for routine investigations and those recommended as additional tests. Currently, there is no generally accepted gold standard protocol. Conclusions The value of a systematic and comprehensive stillbirth investigation, which includes a wide range of diagnostic modalities and techniques, is not in doubt. However, it is yet to be determined which components should be considered the most relevant and efficient for stillbirth investigation. Currently none of the publicly available formal protocols is generally accepted as a reference protocol. They vary in some of their recommendations, suggesting that there may be a role for further individualization of tests or examinations used for stillbirth investigation. Findings from this review highlight the diagnostic contribution and the important role of fetal autopsy and placental examination as integral components of a comprehensive and relevant stillbirth investigation. These procedures remain important in the confirmation and further delineation of the cause of fetal death. These data may be helpful in counselling patients who are considering the difficult decision of whether or not to consent to a postmortem examination following a stillbirth. Methodology Selected for this review were research studies reporting on stillbirths that were investigated using a specific protocol, test, or examination to determine the cause of death. All research studies were identified by conducting a systematic search of the medical literature published between 1985 and June 2005. The search included Cochrane Library, PubMed, EMBASE, CINAHL, HealthSTAR, Science Citation Index, BIOSIS, and the websites of various health technology assessment agencies, research registers, evidence-based resources, and practice guidelines sites. No language restriction was applied. Studies were date restricted to 1985 onward. The medical literature was also searched to identify publicly available formal protocols. HTA Report # 36 October 2005 iii ACKNOWLEDGEMENTS The Alberta Heritage Foundation for Medical Research is most grateful to the following persons for provision of information, comments, or both on the draft report: Dr. Fiona Bamforth, University of Alberta, Edmonton, Alberta, Canada Ms. Vicki Flenady, on behalf of the Perinatal Society of Australia and New Zealand Perinatal Mortality Group, c/- Centre for Clinical Studies, Mater Research Support Centre and Centre for Clinical Studies Aubigny Place, Mater Health Services, South Brisbane, Queensland, Australia (http://www.psanzpnmsig.org) Professor Ellen Hodnett, Perinatal Nursing Research, University of Toronto Faculty of Nursing, Toronto, Ontario, Canada Dr. Fergall Magee, Department of Pathology and Laboratory Medicine, Children’s & Women’s Health Centre of British Columbia, University of British Columbia, Vancouver, British Columbia, Canada Dr. Richard M. Pauli, Wisconsin Stillbirth Service Program, University of Wisconsin Clinical Genetics Center, Madison, Wisconsin, United States of America Dr. Bob Rennie, Medical Microbiology Laboratory, University of Alberta, Edmonton, Alberta, Canada Dr. Eric Stearns, College of Physicians and Surgeons of Manitoba, Winnipeg, Manitoba, Canada In preparing this report, the Foundation was assisted by Grace Guyon, Coordinator for the Alberta Perinatal Health Program, who provided advice and comments on the report. Information Services Support Ms. Liza Chan, Research Librarian, Alberta Heritage Foundation for Medical Research, Edmonton, Alberta, Canada CONFLICT OF INTEREST Conflict of interest is considered to be financial interest, either direct or indirect, that would be affected by the research contained in this report, or creation of a situation where an author’s judgement could be unduly influence by a secondary interest such as personal advancement. Based on the statement above, no conflict of interest exists with the authors of this report. The views expressed in the final report are those of the Foundation. HTA Report #36 October 2005 iv ABBREVIATIONS/GLOSSARY Abbreviations AMA – Alberta Medical Association ANA – antinuclear
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