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临床试验/NCT03840889
NCT03840889Unknown不适用

Incidence and Risk Factors for Secondary Severe Postpartum Hemorrhage in the General Population

University Hospital, Clermont-Ferrand10 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
10
主要终点
Incidence of severe secondary PPH in the general population

研究概览

简要总结

Postpartum hemorrhage (PPH) remains one of the leading causes of maternal mortality and morbidity worldwide, including in France, where it accounts for approximately 20% of maternal mortality. Although numerous studies have examined immediate PPH, very few have explored secondary (also called late) PPH. Moreover, there are no guidelines in France for the management of secondary PPH. Its frequency appears to vary from 0.2% to 3.0% of deliveries. It is, however, difficult to estimate because only severe secondary PPH will lead to hospitalization and the rare publications concern single-center studies. The cause of these secondary hemorrhages is often unknown, due to the lack of routine uterine aspiration. Nonetheless, this aspiration is not always medically justified. The principal objective of this study is thus to establish the incidence of severe late PPH in the general population.

详细描述

  1. Justification of the non-interventional nature of the study:

Severe late PPH is a rare disorder that can be difficult to diagnose. It is a source of severe maternal morbidity; its management is not well defined; and the lack of knowledge of its risk factors means that groups of women at risk of this disorder cannot be identified. Because of the lack of scientific data, it is impossible to set up monitoring appropriate to each woman's risk or to provide women who have just given birth with appropriate information.

The practices studied will be those usually used in the healthcare facilities in Auvergne that manage PPH. The data useful for this study will be those collected routinely in medical files, but will be collected prospectively for women who are hospitalized after a severe late PPH. Investigators conducted this type of data collection for the Hera study (national PHRC), which covered immediate postpartum hemorrhages, for which management is well codified through the national good clinical practice guidelines, updated in 2014 .The section on the management of secondary hemorrhages shows the sparseness of the relevant scientific data on this subject. The guidelines are thus based mainly on expert opinion. Accordingly, the value of this study is that it will begin to develop an evidence base for the management of this disorder. The guidelines specify that "the management of late PPH depends on their cause and their severity [antibiotic therapy (Grade A) and uterotonic agents (professional consensus)]. This treatment must follow the hospital's own protocols (professional consensus). Most often, women are admitted for this management (professional consensus). In the case of persistence of the PPH and retention of placental fragments, aspiration-curettage under ultrasound control or operative hysteroscopy is recommended (professional consensus). In cases of vascular abnormalities, selective embolization is the treatment of choice (professional consensus)." This study will not direct professionals to use any specific rules or practices for the management of these late hemorrhages, other than the national guidelines cited above. Because of the great autonomy it offers for this management, it probably results in substantial heterogeneity in care, which this study will observe and examine. At the end of the study, investigator hope to have highlighted the most relevant management practices by cause of these severe late PPH. 2. Procedure for early withdrawal from the study: the woman's refusal to participate in the study. 3. Methods of recruitment:

Women with a severe late PPH will be recruited prospectively after verification of the inclusion criteria by a gynecologist-obstetrician or the investigating midwives, who will provide the patients information about the study and include them unless they object. 4. Steps taken to reduce and avoid bias:

Because the objective is to determine the incidence of severe late/secondary PPH, investigator will have several investigators at each site to be able to optimize the prospective identification of women meeting the inclusion criteria. Data entry will be performed by a research midwife who will have access to all of the medical data sources at each site (regional computerized pregnancy and delivery records, paper medical records, local computerized file for surgical, laboratory, pathology and imaging reports, hospital computerized discharge summary) to limit missing data. The aim is to obtain an exhaustive list of severe late PPH in the general population, to be ensured by the consultation of multiple data sources. Because these data sources are generated by different institutions and agencies, the selection bias associated by collection from a specific population (e.g., a single center) will be avoided. 5. Collection of data for women with a severe late PPH Patient inclusion and data collection will take place continuously. Every case of severe late PPH among women who give birth in the region of Auvergne will be included.

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
12 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All women presenting a severe secondary postpartum hemorrhage, defined as a genital hemorrhage (intra-abdominal or exteriorized vaginally) between 24 hours and 42 days (6 weeks) after childbirth and requiring either rehospitalization or a medical or interventional procedure during the postpartum hospitalization (medication, vascular embolization, and/or surgical procedures). Women with several episodes of severe secondary postpartum hemorrhage during the 42 days postpartum will be included only once.

排除标准

  • - All women with an immediate PPH, defined as a hemorrhage in the 24 hours after delivery, unassociated with a secondary PPH.
  • All women who did not give birth in Auvergne.
  • All women who returned home after delivery without any medical or interventional procedure during the postpartum hospitalization, with a hemorrhage in the 42 days after delivery, but not rehospitalized, regardless of whether they sought care in an emergency department.

结局指标

主要结局

Incidence of severe secondary PPH in the general population

时间窗: between Day 1 and Day 42

Severe secondary PPH is defined as a genital hemorrhage between Day 1 and Day 42 (6 weeks) after childbirth and requiring hospitalization

次要结局

  • Identification of the risk factors for severe late PPH.(at day 1)
  • Identification of the management protocols most appropriate for women determined to be at risk of severe late PPH(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (10)

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