Prevalence Study of the Etiology of Pregnancy Anemia (PREGAN)

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Anemia

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Marie-Anne Couturier; Phone Number: 0298223421; Email: marie-anne.couturier@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Marie-Anne Couturier; Email: marie-anne.couturier@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant woman with anemia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from date of inclusion until 6 weeks after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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)	from date of inclusion until 6 weeks after delivery

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Anticipated): October 27, 2019
• Study Completion (Anticipated): December 27, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy Anemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: PREGAN (29BRC17.0155)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No