NCT05022979

Brief Summary

Micronutrient deficiencies are frequent in pregnant women in French Guiana, a French territory in South America. Micronutrient deficiencies are more frequent in precarious women. Obesity is a frequent problem but it is also associated with micronutrient deficiency. Micronutrient deficiencies have largely been overlooked in this outermost European region and should be corrected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
341

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

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

May 28, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1 day

First QC Date

July 6, 2021

Last Update Submit

August 24, 2021

Conditions

Keywords

micronutrientsrisks factorssocial inequalities

Outcome Measures

Primary Outcomes (1)

  • Identification of a micronutrient deficiency defined as at least one micronutrient below the lower limit.

    * urinary iodine \< 100 µg/L * blood zinc level \< 70 µg/dL * magnesium \< 0.75 mmol/L * serum retinol \< 0.70 µmol/L * erythrocyte folate \< 305 nmol/L * blood cobalamin level \< 150 pmol/L * Martial status: ferritin \< 20 µg/L; serum iron \< 15 µg/L; iron saturation coefficient of transferrin \< 16%.

    1 day

Secondary Outcomes (5)

  • Sociodemographic information

    1 day

  • assessment of Food diversity score

    1 day

  • Obstetrical and neonatal outcomes

    1 day

  • Newborn health status

    1 day

  • Mother Health status

    1 day

Interventions

The investigator collected the patient's data from the medical record and interviewed the patient to complete the nutritional questionnaire. The required biological, blood and urine samples were collected during routine blood sampling upon entry and hospitalization.

Eligibility Criteria

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

Any woman who was pregnant (22 weeks and more), hospitalized for delivery in the Gynecological and Obstetrical Emergency Unit at Cayenne hospital could participate in the studyafter giving written informed consent.The mode of delivery or urgent/non-urgent context did not influence the eligibility for inclusion. The criteria for non-inclusion were refusal to participate in the study; being under guardianship; and having already been enrolled in the study.

You may qualify if:

  • Pregnant at least 22 weeks of amenorrhea (WHO threshold for fetal viability)
  • Patient hospitalized for delivery in the Gynecological and Obstetrical Emergency Unit at Cayenne hospital
  • Patient's consent
  • Consent of the legal representative if the patient is a minor

You may not qualify if:

  • Refusalto participate in the study.
  • Being under guardianship or curatorship
  • Having been previously enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

Location

Related Publications (1)

  • Duclau A, Abad F, Adenis A, Sabbah N, Leneuve M, Nacher M. Prevalence and risk factors for micronutrient deficiencies during pregnancy in Cayenne, French Guiana. Food Nutr Res. 2021 Feb 22;65. doi: 10.29219/fnr.v65.5268. eCollection 2021.

    PMID: 33776616BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

July 6, 2021

First Posted

August 26, 2021

Study Start

May 28, 2018

Primary Completion

May 29, 2018

Study Completion

March 31, 2019

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations