- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05022979
Prevalence and Risk Factors for Micronutrient Deficiencies During Pregnancy in Cayenne, French Guiana (CarMa)
Prevalence of Micro-nutritional Deficiencies in Pregnant Women Presenting to the Emergency Department for Threatened Delivery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Involved in physical and brain development, immunity and metabolism, micronutrients have profound health effects. The nutritional status of pregnant women is a major determinant of fetal health. French Guiana has a rapid population growth. Social inequalities, cultural practices and gastrointestinal nematode infections in French Guiana could affect the prevalence of these deficiencies. The main objective of the present study was to estimate the prevalence of micronutrient deficiency among pregnant women in French Guiana. The secondary objective was to identify socio-demographic, dietary, obstetrical and neonatal risk factors associated with deficiencies.
Pregnant women over 22 weeks of pregnancy hospitalized for delivery at the Obstetrical Emergency Department of the Hospital Center in Cayenne from May 2018 to March 2019 were included. A socio-demographic and food questionnaire was administered. Medical data were collected from the medical records. Blood and urine samples were taken. The descriptive analysis used Student and Chi2 tests.
A total of 341 women were included. The majority were born in Haiti (39%) and French Guiana (34%). At least one micronutrient deficiency was observed in 81% of women. Precarious women had a significantly greater risk of micronutrient deficiency during pregnancy compared to those with both normal and complementary health insurance.
Micronutrient deficiencies in pregnant women in French Guiana are a public health problem, a fact that was previously overlooked in a context of rising obesity. With over half of women overweight or obese and 81% with at least 1 micronutrient deficiency, balanced nutrition should be a major focus.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cayenne, French Guiana, 97306
- General Hospital of Cayenne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refusalto participate in the study.
- Being under guardianship or curatorship
- Having been previously enrolled in the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of a micronutrient deficiency defined as at least one micronutrient below the lower limit.
Time Frame: 1 day
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic information
Time Frame: 1 day
|
Socio-demographic and dietary risk factors associated with micronutrient deficiencies were investigated using a structured questionnaire.
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1 day
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assessment of Food diversity score
Time Frame: 1 day
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The food diversity score was inspired by the Food and Agriculture Organization's reports was assessed through a 24h recall, and calculated by adding the number of unique food groups consumed during last 24 hours.
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1 day
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Obstetrical and neonatal outcomes
Time Frame: 1 day
|
Obstetrical and neonatal pathologies associated with micronutrient deficiencies were studied throughpatient interrogation and by analyzing medical records: rate of preeclampsia
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1 day
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|
Newborn health status
Time Frame: 1 day
|
Gestational age at delivery, mode of delivery, weight, height, height, head circumference, APGAR, pathologies diagnosed on clinical examination before the 8th day of life
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1 day
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Mother Health status
Time Frame: 1 day
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Weight before pregnancy and on the day of inclusion, height, gestational age, pregnancy follow-up, microcytic anemia (hemoglobinemia <110 g/L, GMV >80 fl), primary hypothyroidism (increased TSH), gynaecological-obstetrical history, personal history of goiter or dysthyroidism, history of night blindness, personal history of anemia, other chronic conditions, history of digestive disorder/parasitoses, malaria history, drug treatment before and during pregnancy, micronutrient supplementation before and during pregnancy, tobacco use during pregnancy, alcohol use during pregnancy
|
1 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CARMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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