Real-world experience of adding placental histopathology studies into perinatal clinical trials. (May 2023)

• Record Type: Journal Article
• Authors: Khong, T. Yee; Gordijn, Sanne J.; Schoots, Mirthe H.; Ganzevoort, Wessel; Groom, Katie M.; Coat, Suzette; Hague, William M.
• Is Part Of: Placenta. Volume 136(2023)
• Page Start: 26
• Page End: 28
• Publication Date: 2023-05
• Subjects: Placenta -- Pathology -- Trial -- Lessons -- Multicentre -- Multinational; Placenta -- Periodicals; Reproduction -- Periodicals; Placenta -- Periodicals; Placenta -- Périodiques; Reproduction -- Périodiques; 612.63
• DOI: 10.1016/j.placenta.2023.03.007
• Languages: English
• ISSNs: 0143-4004

Abstract

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. Highlights: Adding placental histopathology into perinatal clinical trials, especially if multi-centre, can be challenging. Issues are mainly practical and relate to meeting regulatory and ethics requirements, and operational and reporting procedures. Fully-costed funding facilitates easier incorporation of placental histopathology into perinatal clinical trials.