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PREGAN: Prevalence Study of the Etiology of Pregnancy Anemia

Sponsor
University Hospital, Brest (Other)
Overall Status
Unknown status
CT.gov ID
NCT03448432
Collaborator
(none)
700
Enrollment
1
Location
21.9
Anticipated Duration (Months)
31.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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. Specific management of anemia is so needed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence Study of the Etiologies of Pregnancy Anemias
    Actual Study Start Date :
    Feb 27, 2018
    Anticipated Primary Completion Date :
    Oct 27, 2019
    Anticipated Study Completion Date :
    Dec 27, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of the etiologies of anemias occured during pregnancy [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.

    Secondary Outcome Measures

    1. Study of obstetrical complications in women with anemia [from date of inclusion until delivery]

      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)

    2. Study of the evolution of anemia during pregnancy and postpartum [from date of inclusion until 6 weeks after delivery]

      Measure of the Hb level monthly and at 6 weeks after delivery

    3. Describe the etiological and therapeutic management of pregnancy anemias [from date of inclusion until 6 weeks after delivery]

      therapeutic management : etiologic treatment (supplemental iron, vitaminic replacement, others) and symptomatic treatment (numbers and rhythm of transfusions)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • woman 18-years or older

    • woman with a normal pregnancy

    • anemia with accidental or symptomatic discovery, whatever the term of pregnancy

    • non opposition collected

    Exclusion Criteria:

    • Refuse to participate

    • Stopped pregnancy whatever the term

    • Medical abortion of pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03448432
    Other Study ID Numbers:
    • PREGAN (29BRC17.0155)
    First Posted:
    Feb 28, 2018
    Last Update Posted:
    Mar 5, 2018
    Last Verified:
    Feb 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    Pregnancy Anemia
    Additional relevant MeSH terms:
    Anemia

    Study Results

    No Results Posted as of Mar 5, 2018