Pregnancy ComplicationsFeydarjanNCT06538753
Silver Leaf During Pregnancy in French Guiana : Use and Impact on Health
An observational study of Pregnancy Complications and Herbal Medicine Adverse Reaction, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial 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 Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Herbal Medicine Adverse Reaction
- How many people
- 332 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 21 Mar 2023to 7 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women delivering in one of the French Guiana maternity hospitals and previously included in study Nutri Pou Ti Moun 1
Who may be able to join
- Women admitted for delivery in one of the French Guiana maternity hospitals and previsouly included in the study Nutri Pou Ti Moun 1 (NCT05653128)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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...).
- Keywords
- Pregnancy, Traditional medecine use, Traditional medecine adverse reaction, Silver leaf, French Guiana
- Medical subject headings
- Pregnancy Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of silver leaf decoction use
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
Measured: At inclusion
Secondary outcomes (5)
Description of pregnancy outcomes
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
Measured: At inclusion
Description of immediate post-partum outcomes
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
Measured: At inclusion
Description of delivery pain management method
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
Measured: At inclusion
Use and representations of women using SLDs
To describe how women use SLDs during delivery assessed by a questionnaire
Measured: At inclusion
Health professionals comprehensions on SLDs use during delivery
To describe the comprehensions of health professionals on SLDs use during delivery assessed by a questionnaire
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start21 Mar 2023
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celia BASURKO, MD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538753
- Sponsor's protocol ID
- Fey darjan
- Acronym
- Feydarjan
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9127815Antonio 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.
PubMed 35497754Antonio 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.
PubMed 32120118Guterres 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.
PubMed 23892138
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver Leaf During Pregnancy in French Guiana : Use and Impact on Health
- ClinicalTrials.gov ID
- NCT06538753
- Acronym / sponsor ID
- Feydarjan / Fey darjan
- Keywords
- Pregnancy, Traditional medecine use, Traditional medecine adverse reaction, Silver leaf, French Guiana
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women delivering in one of the French Guiana maternity hospitals and previously included in study Nutri Pou Ti Moun 1
Key inclusion criteria (1 listed)
- Women admitted for delivery in one of the French Guiana maternity hospitals and previsouly included in the study Nutri Pou Ti Moun 1 (NCT05653128)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Description of pregnancy outcomes
Time frame: At inclusion
Description of immediate post-partum outcomes
Time frame: At inclusion
Description of delivery pain management method
Time frame: At inclusion
Use and representations of women using SLDs
Time frame: At inclusion
Health professionals comprehensions on SLDs use during delivery
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 9127815Chang 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.
- Background: PubMed 35497754Antonio 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.
- Background: PubMed 32120118Antonio 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.
- Background: PubMed 23892138Guterres 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.
- 2016 Perinatal national report survey - Situation and evolution since 2010Link provided by the sponsor.
- Traditional pharmacopoeia in Frecnh GuianaLink provided by the sponsor.
- Plants of love : ethnobotany of plant species used for sexual purposes in Afro-descendant communities in French GuianaLink provided by the sponsor.
- The hybrid pharmacopoeias of French Guiana : ethnobotany of a phytotherapy on the moveLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia BASURKO, MD principal investigator
Centre Hospitalier de Cayenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Herbal Medicine Adverse Reaction, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of silver leaf decoction use (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538753, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.