Real-world experience of adding placental histopathology studies into perinatal clinical trials

T Yee Khong; Sanne J Gordijn; Mirthe H Schoots; Wessel Ganzevoort; Katie M Groom; Suzette Coat; William M Hague

doi:10.1016/j.placenta.2023.03.007

Real-world experience of adding placental histopathology studies into perinatal clinical trials

Placenta. 2023 May:136:26-28. doi: 10.1016/j.placenta.2023.03.007. Epub 2023 Mar 31.

Authors

T Yee Khong¹, Sanne J Gordijn², Mirthe H Schoots³, Wessel Ganzevoort⁴, Katie M Groom⁵, Suzette Coat⁶, William M Hague⁷

Affiliations

¹ SA Pathology, Women's and Children's Hospital, The University of Adelaide, Adelaide, Australia. Electronic address: yee.khong@adelaide.edu.au.
² Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: s.j.gordijn@umcg.nl.
³ Department of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: m.h.schoots@umcg.nl.
⁴ Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers, Universiteit van Amsterdam, the Netherlands. Electronic address: j.w.ganzevoort@amsterdamumc.nl.
⁵ Liggins Institute, University of Auckland, Auckland, New Zealand. Electronic address: k.groom@auckland.ac.nz.
⁶ Robinson Research Institute, The University of Adelaide, Adelaide, Australia. Electronic address: suzette.coat@adelaide.edu.au.
⁷ Robinson Research Institute, The University of Adelaide, Adelaide, Australia. Electronic address: bill.hague@adelaide.edu.au.

PMID: 37023681
DOI: 10.1016/j.placenta.2023.03.007

Abstract

Addition of placental histopathology studies to obstetric trials is likely to be cost-effective and may reveal structural changes suggestive of functional dysfunction to explain the success or failure of a clinical intervention. We share our recent experience in adding placental pathological examination to two clinical trials, retrospectively in one and at the outset in the other, so that other clinical trial investigators may benefit from it. The practical issues can be summarised as being regulatory and ethical, operational and reporting. Prospective inclusion of placental pathological examination as part of a clinical trial protocol is easier than retrospective, and is facilitated by fully-costed funding.

Keywords: Lessons; Multicentre; Multinational; Pathology; Placenta; Trial.

MeSH terms

Female
Humans
Placenta* / pathology
Pregnancy
Prospective Studies
Research*
Retrospective Studies