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

T. Yee Khong^*, Sanne J. Gordijn, Mirthe H. Schoots, Wessel Ganzevoort, Katie M. Groom, Suzette Coat, William M. Hague

^*Corresponding author for this work

Reproductive Origins of Adult Health and Disease (ROAHD)

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Pages (from-to)	26-28
Number of pages	3
Journal	Placenta
Volume	136
DOIs	https://doi.org/10.1016/j.placenta.2023.03.007
Publication status	Published - May-2023

Keywords

Lessons
Multicentre
Multinational
Pathology
Placenta
Trial

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title = "Real-world experience of adding placental histopathology studies into perinatal clinical trials",

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.",

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author = "Khong, {T. Yee} and Gordijn, {Sanne J.} and Schoots, {Mirthe H.} and Wessel Ganzevoort and Groom, {Katie M.} and Suzette Coat and Hague, {William M.}",

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AU - Khong, T. Yee

AU - Gordijn, Sanne J.

AU - Schoots, Mirthe H.

AU - Ganzevoort, Wessel

AU - Groom, Katie M.

AU - Coat, Suzette

AU - Hague, William M.

PY - 2023/5

Y1 - 2023/5

N2 - 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.

AB - 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.

KW - Lessons

KW - Multicentre

KW - Multinational

KW - Pathology

KW - Placenta

KW - Trial

U2 - 10.1016/j.placenta.2023.03.007

DO - 10.1016/j.placenta.2023.03.007

M3 - Article

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AN - SCOPUS:85151542615

SN - 0143-4004

VL - 136

SP - 26

EP - 28

JO - Placenta

JF - Placenta

ER -

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

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