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临床试验/NCT02118038
NCT02118038已完成不适用

Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 329 人开始时间: 2014年11月21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
329
试验地点
1
主要终点
Identification of risk factors for psychological impact of PPH

研究概览

简要总结

To assess the impact and to identify the main risk factors for psychological and cardiac morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum hemorrhage

详细描述

The HELP- MOM study is an observational study that seeks to identify the major determinants of morbidity induced by postpartum hemorrhage (PPH) in the short and medium term. Even if PPH remains the leading cause of death in the world and in France , its main impact in so-called developed countries is not so much maternal mortality ( which is very small ) but induced morbidity.Data from the literature suggest that in a number of cases, PPH is associated with cardiac abnormalities. The nature of the abnormalities, their potential impact on the functioning of the cardiovascular system of women and their evolution over time (possibility of persistent sequelae) are not known. Similarly, it is known that the postpartum period of normal pregnancy followed by a normal delivery is at risk of psychological disorders in the mother. The PPH is a very serious situation where sometimes the vital prognosis of the mother was committed. Again, determining the exact nature and consequences of psychological harm secondary PPH are not known. Finally, fertility and the risk of recurrence after an episode PPH are also poorly understood. Outside hysterectomy hemostasis which permanently affects the fertility of the patient, the severity and type of management of PPH most likely affect fertility. Only a long-term monitoring could help address this issue. Thus, HELP MOM - study aims to address these issues. To do this, HELP MOM, was divided into two sub- studies : 1) HELP-MOM 1 "multidisciplinaire" which corresponds to the cohort of patients in whom psychological state will be studied in the immediate waning PPH then during a 6 months through appropriate questionnaires , 2 ) HELP-MOM 2 "cardio" that corresponds to the cohort of patients who experienced a cardiac abnormality in the initial management and will therefore be included in a cardiac monitoring.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients with postpartum hemorrhage and receiving sulprostone
  • Patient affiliated with social security
  • Enrolled HELMOM1
  • Presence of one or more items from the following list at the moment of PPH:
  • elevated troponin ("classical" or ultra) exceeds 5 times the normal value (about> 0.20 g / ml depending on the laboratory) and / or
  • electrocardiographic abnormalities (ST-segment abnormalities and / or T wave abnormalities searched in all 12 leads) and / or
  • rate of BNP (Brain Natriuretic Peptide) greater than 100 pg / m

排除标准

  • Age < 18 years
  • Hemorrhage caused by a miscarriage, a clandestine abortion, fetal death in utero or medical or voluntary termination of pregnancy.
  • Patient with pace maker

结局指标

主要结局

Identification of risk factors for psychological impact of PPH

时间窗: 6 months

Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)

Occurrence of a cardiac event

时间窗: Day0

Occurrence of a cardiac event, defined as an elevation of troponin or BNP or an EKG modification during the acute phase of postpartum hemorrhage (PPH) (HELPMOM2)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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