Clinical trial NCT06538753: Silver Leaf During Pregnancy in French Guiana : Use and Impact on Health
Official title: Silver Leaf During Pregnancy in French Guiana : Use and Impact on Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Herbal Medicine Adverse Reaction
Keywords: Pregnancy
Traditional medecine use
Traditional medecine adverse reaction
Silver leaf
French Guiana
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 332
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women delivering in one of the French Guiana maternity hospitals and previously included in study Nutri Pou Ti Moun 1

Brief summary: 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

Detailed description: 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...).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of silver leaf decoction use
timeFrame: At inclusion
Secondary outcomes:
measure: Description of pregnancy outcomes
timeFrame: At inclusion
measure: Description of immediate post-partum outcomes
timeFrame: At inclusion
measure: Description of delivery pain management method
timeFrame: At inclusion
measure: Use and representations of women using SLDs
timeFrame: At inclusion
measure: Health professionals comprehensions on SLDs use during delivery
timeFrame: At inclusion
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: Centre Hospitalier de Cayenne
Study officials:
affiliation: Centre Hospitalier de Cayenne
name: Celia BASURKO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang CW, Ko FN, Su MJ, Wu YC, Teng CM. Pharmacological evaluation of ocoteine, isolated from Cassytha filiformis, as an alpha 1-adrenoceptor antagonist in rat thoracic aorta. Jpn J Pharmacol. 1997 Mar;73(3):207-14. doi: 10.1254/jjp.73.207.
citation: Antonio ADS, Aguiar ATC, Dos Santos GRC, Pereira HMG, da Veiga-Junior VF, Wiedemann LSM. Phytochemistry by design: a case study of the chemical composition of Ocotea guianensis optimized extracts focused on untargeted metabolomics analysis. RSC Adv. 2020 Jan 21;10(6):3459-3471. doi: 10.1039/c9ra10436d. eCollection 2020 Jan 16.
citation: Antonio AS, Veiga-Junior VF, Wiedemann LSM. Ocotea complex: A metabolomic analysis of a Lauraceae genus. Phytochemistry. 2020 May;173:112314. doi: 10.1016/j.phytochem.2020.112314. Epub 2020 Feb 29.
citation: Guterres Zda R, da Silva AF, Garcez WS, Garcez FR, Fernandes CA, Garcez FR. Mutagenicity and recombinagenicity of Ocotea acutifolia (Lauraceae) aporphinoid alkaloids. Mutat Res. 2013 Sep 18;757(1):91-6. doi: 10.1016/j.mrgentox.2013.07.004. Epub 2013 Jul 24.