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临床试验/NCT06538753
NCT06538753已完成不适用

Silver Leaf During Pregnancy in French Guiana : Use and Impact on Health

Centre Hospitalier de Cayenne1 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2023年3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
332
试验地点
1
主要终点
Prevalence of silver leaf decoction use

研究概览

简要总结

This is a descriptive, observational, cross-sectional study among women who have given birth in one of French Guiana's maternity hospitals to determine if the use of silver leaf is frequent and could have an impact on pregancy outcomes. This Fey darjan project is an ancillary study of the Nutri Pou Ti'Moun 1 project

详细描述

French Guiana's ethnomedicines use is still very dynamic, with a significant level of herbal medicine use per inhabitant (17.6 citations of use per inhabitant surveyed) and the continual integration of new species into the local medicinal flora. Over a period of 30 years, studies noted significant changes and mutations in plant-based care methods, favored by a significant intercultural mix (close border areas and migrant population from the Caribbean and South America).

The species Ocotea guianensis Aublet (Lauraceae), known in French Guiana as 'feuille d'argent' (féy darjan in Creole, silvon leaf in english), is used locally to facilitate childbirth. This use (a decoction of leaves administered to parturients as a sitz bath) among the Palikur (an indigenous Amerindian people from northern Amapá in Brazil and eastern French Guiana) and coastal Creoles. This use has been observed more recently by Tareau (2020) among Haitian and Guyanese Creole women According to a preliminary study by a perinatal network in French Guiana, cases of acute foetal distress at the time of delivery and post-partum haemorrhage have been observed in pregnant women who have used silver leaf decoctions, without a statistical or pathophysiological link being formally established.

From an epidemiological point of view, the frequency of use of Silver Leaf Decoctions (SLD) and the medical consequences of this use during childbirth and the immediate post-partum period have not been quantified in French Guiana. Although health-care providers have observed that some women use SLDs when certain pathological events occur during childbirth, no study has demonstrated a definite link between SLDs and complicated childbirth.

The profile of users, the ways in which SLDs are used during pregnancy, and their impact on childbirth, uterine contractions and the immediate post-partum period also need to be clarified. The perception and representations of this practice from the point of view of caregivers are also elements to be taken into consideration.

The research hypothesis is that the use of silver leaf by parturients in French Guiana is frequent and could have an impact on pregnancy outcomes (prolonged labor, ineffective contractions, perinatal pain, cardio-fetal rhythm abnormalities, post-partum hemorrhage...).

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women admitted for delivery in one of the French Guiana maternity hospitals and previsouly included in the study Nutri Pou Ti Moun 1 (NCT05653128)

排除标准

  • Refusal to participate to study or absence of collection of non-opposition of participant
  • Lack of parental consent for minor participants
  • Women under gardianship or curatorship

结局指标

主要结局

Prevalence of silver leaf decoction use

时间窗: At inclusion

To estimate the prevalence of silver leaf decoction use among women who gave birth in one of the French Guiana maternity hospitals assessed by a questionnaire

次要结局

  • Use and representations of women using SLDs(At inclusion)
  • Health professionals comprehensions on SLDs use during delivery(At inclusion)
  • Description of immediate post-partum outcomes(At inclusion)
  • Description of delivery pain management method(At inclusion)
  • Description of pregnancy outcomes(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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