Pregnancy AnemiaPREGANNCT03448432
Prevalence Study of the Etiology of Pregnancy Anemia
An observational study of Pregnancy Anemia, run by University Hospital, Brest at 1 site in France.
Trial summary
Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Anemia
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2018to 27 Dec 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant woman with anemia
Who may be able to join
- woman 18-years or older
- woman with a normal pregnancy
- anemia with accidental or symptomatic discovery, whatever the term of pregnancy
- non opposition collected
Who cannot join
- Refuse to participate
- Stopped pregnancy whatever the term
- Medical abortion of pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Marie-Anne Couturier, marie-anne.couturier@chu-brest.fr
About this study
Official title: Prevalence Study of the Etiologies of Pregnancy Anemias
Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Specific management of anemia is so needed.
- Conditions
- Pregnancy Anemia
- Keywords
- Pregnancy Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the etiologies of anemias occured during pregnancy
Anemia in pregnancy is defined as hemoglobin level (Hb) < 11 g/dL in the first and the third trimesters, and Hb < 10.5 g/dL in the second trimester.
Measured: from date of inclusion until 6 weeks after delivery
Secondary outcomes (3)
Study of obstetrical complications in women with anemia
- Measure of the incidence of postpartum haemorrhage, instrumental extractions, caesareans sections, premature delivery, intra-uterine growth restriction or small for gestational age, placenta abruption, preeclampsia and low birth-weight newborn (<3rd and <10th percentile under neonatal morphometry curves)
- Level of release,
- 1-, 3- and 5-minutes Apgar score,
- Arterial ans venous cord potential hydrogen (pH)
Measured: from date of inclusion until delivery
Study of the evolution of anemia during pregnancy and postpartum
Measure of the Hb level monthly and at 6 weeks after delivery
Measured: from date of inclusion until 6 weeks after delivery
Describe the etiological and therapeutic management of pregnancy anemias
therapeutic management : etiologic treatment (supplemental iron, vitaminic replacement, others) and symptomatic treatment (numbers and rhythm of transfusions)
Measured: from date of inclusion until 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start27 Feb 2018
- Primary completion27 Oct 2019 (estimated)
- Study completion27 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448432
- Sponsor's protocol ID
- PREGAN (29BRC17.0155)
- Acronym
- PREGAN
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Study of the Etiologies of Pregnancy Anemias
- ClinicalTrials.gov ID
- NCT03448432
- Acronym / sponsor ID
- PREGAN / PREGAN (29BRC17.0155)
- Conditions
- Pregnancy Anemia
- Keywords
- Pregnancy Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 27 Oct 2019 (estimated)
- Study completion
- 27 Dec 2019 (estimated)
- First posted
- 28 Feb 2018 (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.
Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Specific management of anemia is so needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant woman with anemia
Key inclusion criteria (4 listed)
- woman 18-years or older
- woman with a normal pregnancy
- anemia with accidental or symptomatic discovery, whatever the term of pregnancy
- non opposition collected
Key exclusion criteria (3 listed)
- Refuse to participate
- Stopped pregnancy whatever the term
- Medical abortion of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of the etiologies of anemias occured during pregnancy
Time frame: from date of inclusion until 6 weeks after delivery
Anemia in pregnancy is defined as hemoglobin level (Hb) < 11 g/dL in the first and the third trimesters, and Hb < 10.5 g/dL in the second trimester.
3 secondary outcomes
Study of obstetrical complications in women with anemia
Time frame: from date of inclusion until delivery
Study of the evolution of anemia during pregnancy and postpartum
Time frame: from date of inclusion until 6 weeks after delivery
Describe the etiological and therapeutic management of pregnancy anemias
Time frame: from date of inclusion until 6 weeks after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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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.
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 Pregnancy Anemia, run by University Hospital, Brest 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 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: status not confirmed, as of the sponsor's last update on 5 Mar 2018. 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?
Contact Marie-Anne Couturier (0298223421, marie-anne.couturier@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the etiologies of anemias occured during pregnancy (time frame: from date of inclusion until 6 weeks after delivery). 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 Mar 2018.