Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538753
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Silver Leaf During Pregnancy in French Guiana Use and Impact on Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Silver Leaf During Pregnancy in French Guiana Use and Impact on Health
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Feydarjan
Brief Summary:
This is a descriptive observational cross-sectional study among women who have given birth in one of French Guianas 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 TiMoun 1 project
Detailed Description:
French Guianas ethnomedicines use is still very dynamic with a significant level of herbal medicine use per inhabitant 176 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 dargent 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
The species Ocotea guianensis Aublet Lauraceae known in French Guiana as feuille dargent 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None