NCT05653128

Brief Summary

This is a cross-sectional study of a representative sample of women who gave birth in the 3 maternity hospitals of French Guiana. The main objective is to estimate the prevalence of food insecurity among pregnant women admitted for delivery in one of the maternity hospitals of French Guiana. A biological assay of deficiencies and toxic metals as well as the completion of a questionnaire will answer the research question

Trial Health

87
On Track

Trial Health Score

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

Enrollment
788

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

November 18, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 19, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

November 18, 2022

Last Update Submit

July 25, 2024

Conditions

Keywords

French GuianaPregnancyFood securityCross-section studyNutritionSocial inequality in health

Outcome Measures

Primary Outcomes (1)

  • Household food insecurity

    The primary measure of household food security was conducted using the Household Food Security Scale (HFSSM) validated by the United States Department of Agriculture (USDA) at inclusion

    At inclusion

Secondary Outcomes (7)

  • Evaluation of coping strategies

    At inclusion

  • Evaluation of the Food Insecurity Experience

    At inclusion

  • Evaluation of the food consumption frequencies in the past 3 months

    At inclusion

  • Evaluation of the socio-demographic profile of the household

    At inclusion

  • Evaluation of the economic profile of the household

    At inclusion

  • +2 more secondary outcomes

Eligibility Criteria

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

Women admitted for delivery in one of the maternity hospitals in French Guiana

You may qualify if:

  • Women admitted for delivery in one of the maternity hospitals in French Guiana

You may not qualify if:

  • refusal to participate or lack of collected non-opposition
  • lack of parental consent for women under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier de Cayenne

Cayenne, 97300, French Guiana

Location

Centre Hospitalier de Kourou

Kourou, 97380, French Guiana

Location

Centre Hospitalier de l'Ouest Guyanais

Saint-Laurent-du-Maroni, 97320, French Guiana

Location

Related Publications (11)

  • Roberton T, Carter ED, Chou VB, Stegmuller AR, Jackson BD, Tam Y, Sawadogo-Lewis T, Walker N. Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study. Lancet Glob Health. 2020 Jul;8(7):e901-e908. doi: 10.1016/S2214-109X(20)30229-1. Epub 2020 May 12.

    PMID: 32405459BACKGROUND
  • Pena-Rosas JP, De-Regil LM, Garcia-Casal MN, Dowswell T. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2015 Jul 22;2015(7):CD004736. doi: 10.1002/14651858.CD004736.pub5.

    PMID: 26198451BACKGROUND
  • Aghajafari F, Nagulesapillai T, Ronksley PE, Tough SC, O'Beirne M, Rabi DM. Association between maternal serum 25-hydroxyvitamin D level and pregnancy and neonatal outcomes: systematic review and meta-analysis of observational studies. BMJ. 2013 Mar 26;346:f1169. doi: 10.1136/bmj.f1169.

    PMID: 23533188BACKGROUND
  • Hofmeyr GJ, Lawrie TA, Atallah AN, Torloni MR. Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems. Cochrane Database Syst Rev. 2018 Oct 1;10(10):CD001059. doi: 10.1002/14651858.CD001059.pub5.

    PMID: 30277579BACKGROUND
  • Wu G, Bazer FW, Cudd TA, Meininger CJ, Spencer TE. Maternal nutrition and fetal development. J Nutr. 2004 Sep;134(9):2169-72. doi: 10.1093/jn/134.9.2169.

    PMID: 15333699BACKGROUND
  • Richterman A, Raymonville M, Hossain A, Millien C, Joseph JP, Jerome G, Franke MF, Ivers LC. Food insecurity as a risk factor for preterm birth: a prospective facility-based cohort study in rural Haiti. BMJ Glob Health. 2020 Jul;5(7):e002341. doi: 10.1136/bmjgh-2020-002341.

    PMID: 32611679BACKGROUND
  • Moafi F, Kazemi F, Samiei Siboni F, Alimoradi Z. The relationship between food security and quality of life among pregnant women. BMC Pregnancy Childbirth. 2018 Aug 6;18(1):319. doi: 10.1186/s12884-018-1947-2.

    PMID: 30081856BACKGROUND
  • Augusto ALP, de Abreu Rodrigues AV, Domingos TB, Salles-Costa R. Household food insecurity associated with gestacional and neonatal outcomes: a systematic review. BMC Pregnancy Childbirth. 2020 Apr 17;20(1):229. doi: 10.1186/s12884-020-02917-9.

    PMID: 32303221BACKGROUND
  • Khoshgoo M, Eslami O, Khadem Al-Hosseini M, Shidfar F. The Relationship between Household Food Insecurity and Depressive Symptoms among Pregnant Women: A Cross Sectional Study. Iran J Psychiatry. 2020 Apr;15(2):126-133.

    PMID: 32426008BACKGROUND
  • Perez-Escamilla R, Cunningham K, Moran VH. COVID-19 and maternal and child food and nutrition insecurity: a complex syndemic. Matern Child Nutr. 2020 Jul;16(3):e13036. doi: 10.1111/mcn.13036.

    PMID: 32458574BACKGROUND
  • Jones AD, Ngure FM, Pelto G, Young SL. What are we assessing when we measure food security? A compendium and review of current metrics. Adv Nutr. 2013 Sep 1;4(5):481-505. doi: 10.3945/an.113.004119.

    PMID: 24038241BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, Hair sample, Cord blood, Placenta

Study Officials

  • Célia 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

November 18, 2022

First Posted

December 16, 2022

Study Start

January 19, 2023

Primary Completion

September 11, 2023

Study Completion

September 11, 2023

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations