Deficiency; DietCarMaNCT05022979
Prevalence and Risk Factors for Micronutrient Deficiencies During Pregnancy in Cayenne, French Guiana
An observational study of Deficiency; Diet and Pregnancy, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Deficiency; Diet, Pregnancy
- What is being tested?
- Observational only
- How many people
- 341 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 28 May 2018to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Refusalto participate in the study.
- Being under guardianship or curatorship
- Having been previously enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Micro-nutritional Deficiencies in Pregnant Women Presenting to the Emergency Department for Threatened Delivery
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.
Read the 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.
- Conditions
- Deficiency; Diet, Pregnancy
- Being tested
- Observational only
- Keywords
- micronutrients, risks factors, social inequalities
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational onlyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 1 day
Secondary outcomes (5)
Sociodemographic information
Socio-demographic and dietary risk factors associated with micronutrient deficiencies were investigated using a structured questionnaire.
Measured: 1 day
assessment of Food diversity score
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.
Measured: 1 day
Obstetrical and neonatal outcomes
Obstetrical and neonatal pathologies associated with micronutrient deficiencies were studied throughpatient interrogation and by analyzing medical records: rate of preeclampsia
Measured: 1 day
Newborn health status
Gestational age at delivery, mode of delivery, weight, height, height, head circumference, APGAR, pathologies diagnosed on clinical examination before the 8th day of life
Measured: 1 day
Mother Health status
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start28 May 2018
- Primary completion29 May 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deficiency; DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022979
- Sponsor's protocol ID
- CarMa
- Acronym
- CarMa
- Status last verified
- Aug 2021
- First submitted
- 6 Jul 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33776616
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Micro-nutritional Deficiencies in Pregnant Women Presenting to the Emergency Department for Threatened Delivery
- ClinicalTrials.gov ID
- NCT05022979
- Acronym / sponsor ID
- CarMa / CarMa
- Conditions
- Deficiency; Diet, Pregnancy
- Keywords
- micronutrients, risks factors, social inequalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Refusalto participate in the study.
- Being under guardianship or curatorship
- Having been previously enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational onlyThe 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. | Other | – |
Primary outcome
Identification of a micronutrient deficiency defined as at least one micronutrient below the lower limit.
Time frame: 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%.
5 secondary outcomes
Sociodemographic information
Time frame: 1 day
assessment of Food diversity score
Time frame: 1 day
Obstetrical and neonatal outcomes
Time frame: 1 day
Newborn health status
Time frame: 1 day
Mother Health status
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Background: PubMed 33776616Duclau 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deficiency; Diet and Pregnancy, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a micronutrient deficiency defined as at least one micronutrient below the lower limit. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.