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Status unknownNCT03448432PREGANUpdated Mar 5, 2018

Prevalence Study of the Etiology of Pregnancy Anemia

An observational study in Pregnancy Anemia, sponsored by University Hospital, Brest. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by University Hospital, Brest · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
18 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Pregnancy Anemia

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Keywords

  • Pregnancy Anemia
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant woman with anemia

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

Exclusion Criteria:

  • Refuse to participate
  • Stopped pregnancy whatever the term
  • Medical abortion of pregnancy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: from date of inclusion until 6 weeks after delivery

Secondary outcomes

  1. 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)

    Time frame: from date of inclusion until delivery

  2. Study of the evolution of anemia during pregnancy and postpartum

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

    Time frame: from date of inclusion until 6 weeks after delivery

  3. 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)

    Time frame: from date of inclusion until 6 weeks after delivery

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Study locations

1 of 1 sites recruiting
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Registry details

Key details

Study ID
NCT03448432
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Feb 27, 2018
Primary completion
Oct 27, 2019 (estimated)
Completion
Dec 27, 2019 (estimated)
Last update
Mar 5, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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