Iron Deficiency AnemiaIMAGENCT03176147
Iron Metabolism Parameters At First Trimester and preGnancy outcomE
An observational study of Iron Deficiency Anemia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Iron deficiency anemia is the leading cause of anemia during pregnancy, which can still reach 10 to 20% of pregnant women in developed countries, with potentially serious consequences for the child. Systematic iron supplementation remains controversial. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Iron deficiency anemia
- How many people
- 865 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2015to Jan 2018
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The women were screened at the maternity clinic of the gynecology-obstetrics department of CHU Estaing in Clermont-Ferrand, France.
Who may be able to join
- Pregnant women in the first trimester between 11SA and 13 SA + 6 days
- A written agreement is needed
Who cannot join
- Women who do not know enough about reading and writing French to answer questionnaires
- Women under 15 at inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Biological Predictive Factors of Iron Deficiency Anemia in the Third Trimester of Pregnancy
Iron deficiency anemia is the leading cause of anemia during pregnancy, which can still reach 10 to 20% of pregnant women in developed countries, with potentially serious consequences for the child. Systematic iron supplementation remains controversial.
This study aims to identify in the first trimester of pregnancy clinical and biological predictive factors for the occurrence of iron deficiency anemia in the third trimester of pregnancy.
Read the detailed description
Objectives: The main objective is to determine the prevalence of anemia (Hb ≤ 11 g / dl) in the third trimester of pregnancy (T3) and to identify the predictive factors in the first trimester (T1).
Type of study: Prospective monocentric cohort.
Experimental plan: Pregnant women are included during the ultrasound of T1. Written consent will be sought after delivery of the information notice. Hemoglobin, classical iron balance (ferritin, transferrin saturation coefficient) as well as other original parameters: hepcidin and the soluble transferrin receptor are assayed. Socioeconomic and clinical parameters likely to favor an iron deficiency are sought through validated questionnaires. Nutritional advice, combined with martial supplementation if necessary, is given according to a standardized management protocol resulting from the current international recommendations and validated by an internal committee. The prevalence of iron deficiency anemia is determined at T3 (after 34 SA). The predictive factors for this anemia will be sought according to the data collected in T1.
The 2012 WHO's recommendations are in favour of a systematic supplementation of pregnant women. Epidemiological studies show that the anaemia at the end of pregnancy increases the risk of severe anaemia in the postpartum hospital stay and the frequency of transfusions in the mother is multiplied by 9. The quality of life of the mother seems too altered by the anaemia with increased susceptibility to infections, cognitive and emotional disorders in the postpartum period and a decrease of capacity of work and performance. In the human new-born, the anaemia is associated with a risk of prematurity, low weight birth and especially a certain degree of later psycho-motor delay, or even perinatal mortality. Side effects of iron orally, it's cost, make debatable systematic supplementation as interventional studies have given contradictory results in terms of morbidity and mortality infant. In areas where the anaemia prevalence is very high, a systematic supplementation of pregnant by 60 mg of iron (with folic acid) is beneficial in children on clues of psycho-intellectual development at 12, 18 and 24 months while multiple supplementation in micronutrients (containing 30 mg of iron) is not effective. However, systematic supplementation in countries with high socioeconomic level did debate. An Australian study Interventional, controlled, randomized conducted at 430 women showed no efficacy on the intellectual development of children in 4 years, without changing the quality of life of the mother during pregnancy, the authors observing even an increase of abnormal behaviors of the children of the mothers in the Group supplemented iron. In another study, the rational is highly questionable, a treatment by Iron versus placebo was given to pregnant women not anaemic with a high haemoglobin (an average of 14 g/dl): the women who took iron had high blood pressure at the end of pregnancy more and their children had a lower birth for the term weight.
In a developed country such as the France, one can legitimately wonder about the potentially harmful effects of routine iron supplementation for a population of pregnant women mainly not anaemic. In Great Britain of the recently published recommendations are pronounced against a systematic supplementation of iron in pregnant women. Other European authors advocate focused on the rate of ferritin supplementation. However, we are lacking of studies allowing, from clinical criteria and biological precise, to better target pregnant women who could benefit from supplementation of iron in the first quarter.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Iron deficiency anemia
- Keywords
- Anemia, Pregnancy, Hepcidine, Iron
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron deficiency anemiaOther
The prevalence of iron deficiency anemia is determined at T3 (after 34 SA). The predictive factors for this anemia will be sought according to the data collected in T1.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women are included during the ultrasound of T1. Written consent will be sought after delivery of the information notice. Receives: Other: Iron deficiency anemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin value
Measured: in the third trimestry of pregnancy
Secondary outcomes (3)
Rate of clinical and biological factors per patient
demographics and clinical factors and biological factors (hepcidine, ferritine, RST)
Measured: at the first trimestry of pregnancy
Rate of demographics and clinical factors per patient
biological factors (hepcidine, ferritine, RST)
Measured: at the first trimestry of pregnancy
Rate of biological factors per patient
Such as : hepcidine, ferritine, RST
Measured: at the first trimestry of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start12 Nov 2015
- Primary completionJun 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 865 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc RUIVARD, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176147
- Sponsor's protocol ID
- CHU-336
- Other IDs
- 2015-A00454-45
- Acronym
- IMAGE
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Predictive Factors of Iron Deficiency Anemia in the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT03176147
- Acronym / sponsor ID
- IMAGE / CHU-336
- Conditions
- Iron Deficiency Anemia
- Keywords
- Anemia, Pregnancy, Hepcidine, Iron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 865 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 5 Jun 2017 (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.
Iron deficiency anemia is the leading cause of anemia during pregnancy, which can still reach 10 to 20% of pregnant women in developed countries, with potentially serious consequences for the child. Systematic iron supplementation remains controversial.
This study aims to identify in the first trimester of pregnancy clinical and biological predictive factors for the occurrence of iron deficiency anemia in the third trimester of pregnancy.
Detailed description
Objectives: The main objective is to determine the prevalence of anemia (Hb ≤ 11 g / dl) in the third trimester of pregnancy (T3) and to identify the predictive factors in the first trimester (T1).
Type of study: Prospective monocentric cohort.
Experimental plan: Pregnant women are included during the ultrasound of T1. Written consent will be sought after delivery of the information notice. Hemoglobin, classical iron balance (ferritin, transferrin saturation coefficient) as well as other original parameters: hepcidin and the soluble transferrin receptor are assayed. Socioeconomic and clinical parameters likely to favor an iron deficiency are sought through validated questionnaires. Nutritional advice, combined with martial supplementation if necessary, is given according to a standardized management protocol resulting from the current international recommendations and validated by an internal committee. The prevalence of iron deficiency anemia is determined at T3 (after 34 SA). The predictive factors for this anemia will be sought according to the data collected in T1.
The 2012 WHO's recommendations are in favour of a systematic supplementation of pregnant women. Epidemiological studies show that the anaemia at the end of pregnancy increases the risk of severe anaemia in the postpartum hospital stay and the frequency of transfusions in the mother is multiplied by 9. The quality of life of the mother seems too altered by the anaemia with increased susceptibility to infections, cognitive and emotional disorders in the postpartum period and a decrease of capacity of work and performance. In the human new-born, the anaemia is associated with a risk of prematurity, low weight birth and especially a certain degree of later psycho-motor delay, or even perinatal mortality. Side effects of iron orally, it's cost, make debatable systematic supplementation as interventional studies have given contradictory results in terms of morbidity and mortality infant. In areas where the anaemia prevalence is very high, a systematic supplementation of pregnant by 60 mg of iron (with folic acid) is beneficial in children on clues of psycho-intellectual development at 12, 18 and 24 months while multiple supplementation in micronutrients (containing 30 mg of iron) is not effective. However, systematic supplementation in countries with high socioeconomic level did debate. An Australian study Interventional, controlled, randomized conducted at 430 women showed no efficacy on the intellectual development of children in 4 years, without changing the quality of life of the mother during pregnancy, the authors observing even an increase of abnormal behaviors of the children of the mothers in the Group supplemented iron. In another study, the rational is highly questionable, a treatment by Iron versus placebo was given to pregnant women not anaemic with a high haemoglobin (an average of 14 g/dl): the women who took iron had high blood pressure at the end of pregnancy more and their children had a lower birth for the term weight.
In a developed country such as the France, one can legitimately wonder about the potentially harmful effects of routine iron supplementation for a population of pregnant women mainly not anaemic. In Great Britain of the recently published recommendations are pronounced against a systematic supplementation of iron in pregnant women. Other European authors advocate focused on the rate of ferritin supplementation. However, we are lacking of studies allowing, from clinical criteria and biological precise, to better target pregnant women who could benefit from supplementation of iron in the first quarter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Iron deficiency anemiaPregnant women are included during the ultrasound of T1. Written consent will be sought after delivery of the information notice. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The women were screened at the maternity clinic of the gynecology-obstetrics department of CHU Estaing in Clermont-Ferrand, France.
Key inclusion criteria (2 listed)
- Pregnant women in the first trimester between 11SA and 13 SA + 6 days
- A written agreement is needed
Key exclusion criteria (2 listed)
- Women who do not know enough about reading and writing French to answer questionnaires
- Women under 15 at inclusion
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 |
|---|---|---|
| Iron deficiency anemiaThe prevalence of iron deficiency anemia is determined at T3 (after 34 SA). The predictive factors for this anemia will be sought according to the data collected in T1. | Other | Pregnant women |
Primary outcome
Hemoglobin value
Time frame: in the third trimestry of pregnancy
3 secondary outcomes
Rate of clinical and biological factors per patient
Time frame: at the first trimestry of pregnancy
Rate of demographics and clinical factors per patient
Time frame: at the first trimestry of pregnancy
Rate of biological factors per patient
Time frame: at the first trimestry of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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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.
Marc RUIVARD, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
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 Iron Deficiency Anemia, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jun 2017. 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 France. 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?
Results are not available in the source record.
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?
Hemoglobin value (time frame: in the third trimestry of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2017.