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Prevalence Study of the Etiology of Pregnancy Anemia (PREGAN)

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ClinicalTrials.gov Identifier: NCT03448432
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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
Pregnancy Anemia

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence Study of the Etiologies of Pregnancy Anemias
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : October 27, 2019
Estimated Study Completion Date : December 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Study of obstetrical complications in women with anemia [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant woman with anemia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448432


Contacts
Contact: Marie-Anne Couturier 0298223421 marie-anne.couturier@chu-brest.fr

Locations
France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Marie-Anne Couturier       marie-anne.couturier@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03448432     History of Changes
Other Study ID Numbers: PREGAN (29BRC17.0155)
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 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
Hematologic Diseases