Clinical trial NCT04016922: The Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamic and Neonatal Outcome
Official title: Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamics and Neonatal Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Conditions
Keywords: Fetal hemodynamics.
Intrauterine growth restriction
Amniotic fluid index
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \* The pregnant women were divided into three groups:

1. Group A : Patients with mild anemia (Hb concentration: 9.0-10.9 g\\dl).
2. Group B : Patients with moderate anemia (Hb concentration: 7.0-8.9 g\\dl).
3. Group C : Patients with severe anemia (Hb concentration: \>7.0 g\\dl).

Brief summary: This study will be conducted to show the effect of different degrees of maternal iron deficiency anemia on fetal hemodynamics and neonatal outcome and to evaluate the effect of treatment.

Detailed description: Hemoglobin concentration is used to determine the diagnosis and severity of anemia in low resource settings, an indicator that is routinely screened using WHO-defined hemoglobin cutoffs. These thresholds are lower for pregnant women (females ≥ 15 years of age) than non-pregnant women (11.0 g/dl versus 12.0 g/dl). Severity of anemia is determined using additional cutoffs, with severe anemia defined as a hemoglobin level of less than 7.0 g/dl.

Iron deficiency is defined as a condition in which there are no mobilizable iron stores, resulting from a long-term negative iron balance and leading to a compromised supply of iron to the tissues. Finally, the most significant negative consequence of ID is anemia, usually microcytic hypochromic in nature.

IDA has been linked to unfavorable outcomes of pregnancy. It is the most common nutritional disorder in the world affecting two billion people worldwide with pregnant women particularly at risk. According to WHO report, 2001 indicates that IDA is a significant problem throughout the world ranging from 35-75% in developing countries (average 56%) whereas in industrialized countries the average prevalence is 14%.

Distribution of blood flow (between the placental and cerebral regions) is determined with Middle cerebral artery PI/Umbilical artery PI (C/U ratio); this parameter is always \> 1.1 during normal pregnancy, but decreases in the case of hypoxia because of umbilical artery resistance index increase (increase in placental resistance) and cerebral resistance index decrease (cerebral vasodilation).

Perinatal morbidity \& mortality of IUGR infants is 3-20 times greater than normal infants. These cases may be followed with outpatient monitoring and they often deliver at term. However process is not severe enough to stop fetal growth completely or to deteriorate. The umbilical artery and the middle cerebral artery waveforms may be abnormal, without effect is seen on Doppler and growth until 26-32 weeks gestation; Mild utero-placental insufficiency.

Iron deficiency and iron deficiency anemia during pregnancy are risk factors for preterm delivery, prematurity and small for gestational age birth weight. Iron deficiency has a negative effect on intelligence and behavioral development in the infant. It is essential to prevent iron deficiency in the fetus by preventing iron deficiency in the pregnant woman.

Prevention and control is typically achieved through iron fortification of food staples like flour and rice and/or through administration of iron supplements most often in iron tablets. Although iron supplements are widely available and fortified foods constitute a major component of the diet in the developed world, access is limited in the developing world

Eligibility criteria: Inclusion Criteria:

* Pregnant females aged 20- 35 years.
* Gestational age 32 weeks or more.
* Living singleton fetus.

Exclusion Criteria:

* Multifetal pregnancy.
* Patients with chronic illness or medical disorders other than iron deficiency anemia.
* Patients with history of recurrent perinatal deaths or recent blood transfusion or other vitamin deficiency anemia.

Primary outcomes:
measure: Changes in fetal vascular doppler parameters.
timeFrame: 4 months from June 2019 till October 2019
measure: Neonatal birth weight
timeFrame: 4 months June 2019 till October 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasralainy hospital
Study officials:
affiliation: Cairo University
name: Muhamad Ehab, professor
role: STUDY_CHAIR
References:
citation: Breymann C. Iron Deficiency Anemia in Pregnancy. Semin Hematol. 2015 Oct;52(4):339-47. doi: 10.1053/j.seminhematol.2015.07.003. Epub 2015 Jul 10.
citation: Abu-Ouf NM, Jan MM. The impact of maternal iron deficiency and iron deficiency anemia on child's health. Saudi Med J. 2015 Feb;36(2):146-9. doi: 10.15537/smj.2015.2.10289.
citation: Breymann C; Anaemia Working Group. [Current aspects of diagnosis and therapy of iron deficiency anemia in pregnancy]. Praxis (Bern 1994). 2001 Aug 2;90(31-32):1283-91. German.
citation: Lee AI, Okam MM. Anemia in pregnancy. Hematol Oncol Clin North Am. 2011 Apr;25(2):241-59, vii. doi: 10.1016/j.hoc.2011.02.001.
citation: Rasmussen K. Is There a Causal Relationship between Iron Deficiency or Iron-Deficiency Anemia and Weight at Birth, Length of Gestation and Perinatal Mortality? J Nutr. 2001 Feb;131(2S-2):590S-601S; discussion 601S-603S. doi: 10.1093/jn/131.2.590S.