NCT06538753

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 6, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 18, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

PregnancyTraditional medecine useTraditional medecine adverse reactionSilver leafFrench Guiana

Outcome Measures

Primary Outcomes (1)

  • 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

    At inclusion

Secondary Outcomes (5)

  • Description of pregnancy outcomes

    At inclusion

  • Description of immediate post-partum outcomes

    At inclusion

  • Description of delivery pain management method

    At inclusion

  • Use and representations of women using SLDs

    At inclusion

  • Health professionals comprehensions on SLDs use during delivery

    At inclusion

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Cayenne

Cayenne, 97300, French Guiana

Location

Related Publications (4)

  • 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.

    PMID: 9127815BACKGROUND
  • 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.

    PMID: 35497754BACKGROUND
  • 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.

    PMID: 32120118BACKGROUND
  • 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.

    PMID: 23892138BACKGROUND

Related Links

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Celia BASURKO, MD

    Centre Hospitalier de Cayenne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

August 6, 2024

Study Start

March 21, 2023

Primary Completion

July 7, 2023

Study Completion

July 7, 2023

Last Updated

August 6, 2024

Record last verified: 2024-07

Locations