CarMa: Prevalence and Risk Factors for Micronutrient Deficiencies During Pregnancy in Cayenne, French Guiana

Sponsor
Centre Hospitalier de Cayenne (Other)
Overall Status
Completed
CT.gov ID
NCT05022979
Collaborator
(none)
341
1
10.1
33.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational only

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 Design

Study Type:
Observational
Actual Enrollment :
341 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Micro-nutritional Deficiencies in Pregnant Women Presenting to the Emergency Department for Threatened Delivery
Actual Study Start Date :
May 28, 2018
Actual Primary Completion Date :
May 29, 2018
Actual Study Completion Date :
Mar 31, 2019

Outcome Measures

Primary Outcome Measures

  1. Identification of a micronutrient deficiency defined as at least one micronutrient below the lower limit. [1 day]

    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%.

Secondary Outcome Measures

  1. Sociodemographic information [1 day]

    Socio-demographic and dietary risk factors associated with micronutrient deficiencies were investigated using a structured questionnaire.

  2. assessment of Food diversity score [1 day]

    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.

  3. Obstetrical and neonatal outcomes [1 day]

    Obstetrical and neonatal pathologies associated with micronutrient deficiencies were studied throughpatient interrogation and by analyzing medical records: rate of preeclampsia

  4. Newborn health status [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

  5. Mother Health status [1 day]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Hospital of Cayenne Cayenne French Guiana 97306

Sponsors and Collaborators

  • Centre Hospitalier de Cayenne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier de Cayenne
ClinicalTrials.gov Identifier:
NCT05022979
Other Study ID Numbers:
  • CarMa
First Posted:
Aug 26, 2021
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier de Cayenne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021