Prevalence Study of the Etiology of Pregnancy Anemia

Pregnancy Anemia Clinical Trial

— PREGAN  

Official title:

Prevalence Study of the Etiologies of Pregnancy Anemias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448432
• Other study ID #: PREGAN (29BRC17.0155)
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2018
• Last updated: March 2, 2018
• Start date: February 27, 2018
• Est. completion date: December 27, 2019

Study information

• Verified date: February 2018
• Source: University Hospital, Brest
• Contact: Marie-Anne Couturier
• Phone: 0298223421
• Email: marie-anne.couturier[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Specific management of anemia is so needed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 27, 2019
• Est. primary completion date: October 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Pregnancy Anemia

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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