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临床试验/NCT04168606
NCT04168606已完成不适用

Retrospective Descriptive Study on Retroplacental Hematomas in Finistère

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2019年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
1
主要终点
Histological findings in placentas n°2

研究概览

简要总结

Cases with placental abruption will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018. First trimester PAPPA and bhCG levels will be recorded. PlGF levels will be measured in women with an available first trimester serum sample. Histological findings in placentas, course of pregnancies, maternal and fetal characteristics will described and compared between cases with and without placental chronic inflammation.

详细描述

Identification of cases:

Placental abruption cases will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018.

The women diagnosed with placental abruption will be first identified by interrogation of the Medical Registry Department (MRD) of Brest University Hospital and of five other maternities of our county between January 2013 and December 2018, using the keyword "placental abruption".

Simultaneously, placental abruption cases will be identified from the Pathology department files of Brest University Hospital using a computerized database (ADICAP system).

Cases of placental abruption included in the study will be clinically defined and will not be only diagnosed by histological examination. All cases will be reviewed by an experienced obstetrician in order to confirm the diagnosis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • who had a placental abruption (clinically defined)
  • with an available placental histological examination
  • in one of 5 maternities of our county (Finistère, France)
  • between January 2013 and December 2018.

排除标准

  • Medical termination of pregnancy
  • marginal abruption
  • placenta previa
  • cases without histological examination of the placenta
  • histological cases without compatible clinical signs
  • cases from an unselected maternity.

结局指标

主要结局

Histological findings in placentas n°2

时间窗: through study completion, an average of one year

presence of an histologic placental abruption

Histological findings in placentas n°11

时间窗: through study completion, an average of one year

presence of acute inflammation such as acute chorioamniotitis or funiculitis

Histological findings in placentas n°9

时间窗: through study completion, an average of one year

presence of excessive fibrin deposition

Histological findings in placentas n°8

时间窗: through study completion, an average of one year

presence of chorangiosis or erythroblastosis

Histological findings in placentas n°1

时间窗: through study completion, an average of one year

placenta weight

Histological findings in placentas n°5

时间窗: through study completion, an average of one year

presence of thrombi in the chorionic plate or intervillous thrombi

Histological findings in placentas n°4

时间窗: through study completion, an average of one year

presence of an abnormal umbilical cord

Histological findings in placentas n°3

时间窗: through study completion, an average of one year

presence of an abnormal placental set-up

Histological findings in placentas n°6

时间窗: through study completion, an average of one year

presence of maternal vascular malperfusion lesions such as macroscopic or microscopic infarcts, decidual arteriopathy or abnormal villous maturation

Histological findings in placentas n°7

时间窗: through study completion, an average of one year

presence of fetal vascular malperfusion signs such as obliterative fetal vasculopathy or avascular villi

Histological findings in placentas n°10

时间窗: through study completion, an average of one year

presence of chronic inflammation such as villitis or chronic intervillositis of unknown etiology, chronic chorioamniotitis or chronic deciduitis

次要结局

  • Maternal first trimester biological markers n°3(through study completion, an average of one year)
  • Course of the pregnancies n°1(through study completion, an average of one year)
  • Maternal first trimester biological markers n°1(through study completion, an average of one year)
  • Course of the pregnancies n°2(through study completion, an average of one year)
  • maternal characteristics n°2(through study completion, an average of one year)
  • maternal characteristics n°9(through study completion, an average of one year)
  • fetal characteristics n°1(through study completion, an average of one year)
  • fetal characteristics n°2(through study completion, an average of one year)
  • Course of the pregnancies n°4(through study completion, an average of one year)
  • Course of the pregnancies n°6(through study completion, an average of one year)
  • maternal characteristics n°3(through study completion, an average of one year)
  • maternal characteristics n°4(through study completion, an average of one year)
  • maternal characteristics n°11(through study completion, an average of one year)
  • Maternal first trimester biological markers n°2(through study completion, an average of one year)
  • Course of the pregnancies n°5(through study completion, an average of one year)
  • Course of the pregnancies n°9(through study completion, an average of one year)
  • maternal characteristics n°6(through study completion, an average of one year)
  • maternal characteristics n°7(through study completion, an average of one year)
  • maternal characteristics n°8(through study completion, an average of one year)
  • maternal characteristics n°1(through study completion, an average of one year)
  • maternal characteristics n°5(through study completion, an average of one year)
  • maternal characteristics n°10(through study completion, an average of one year)
  • Course of the pregnancies n°3(through study completion, an average of one year)
  • Course of the pregnancies n°7(through study completion, an average of one year)
  • Course of the pregnancies n°8(through study completion, an average of one year)
  • Course of the pregnancies n°10(through study completion, an average of one year)
  • Course of the pregnancies n°11(through study completion, an average of one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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