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Completed

NCT Number: NCT06538753

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

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

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier de Cayenne

Cayenne, 97300, French Guiana

About this study

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...).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of silver leaf decoction use

    Time frame: 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

Secondary outcomes

  1. Description of pregnancy outcomes

    Time frame: At inclusion

    To describe pregnancy outcomes of women using SLDs in the prenatal period in relation to perinatal indicators in French Guiana (gestational diabetis, hypertension, pre-eclampsia/eclampsia, foetal weight abnormalities ), documented from medical file

  2. Description of immediate post-partum outcomes

    Time frame: At inclusion

    To describe immediate post-partum outcomes of women using SLDs in the prenatal period in relation to perinatal indicators in French Guiana (vaginal delivery, C-section, post-partum bleeding, foetal cardio rhythm abnormalities...), documented from medical file

  3. Description of delivery pain management method

    Time frame: At inclusion

    To describe the delivery pain management method of women using SLDs in prenatal period in relation to women not using SLDs (no delivery pain management method, epidural, spinal analgesia, general anaesthetic) documented from medical file

  4. Use and representations of women using SLDs

    Time frame: At inclusion

    To describe how women use SLDs during delivery assessed by a questionnaire

  5. Health professionals comprehensions on SLDs use during delivery

    Time frame: At inclusion

    To describe the comprehensions of health professionals on SLDs use during delivery assessed by a questionnaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cayenne

Other

Registry information

Acronym: Feydarjan

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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