The Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamic and Neonatal Outcome

• Conditions: Fetal Conditions
• Interventions: Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C

• Registration Number: NCT04016922
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2019-06-24
• Status Verified: 2019-07
• Study Start: 2019-07
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-12
• Last Update Submitted: 2019-07-13
• Last Update Posted: 2019-07-16
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C	Patients with moderate anemia (Hb concentration: 7.0-8.9 g\\dl).
Group C	Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C	Patients with severe anemia (Hb concentration: \>7.0 g\\dl).
Group A	Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C	Patients with mild anemia (Hb concentration: 9.0-10.9 g\\dl).

Primary Outcome Measures

Name	Time	Method
Changes in fetal vascular doppler parameters.	4 months from June 2019 till October 2019	Fetal doppler parameters by resistance index and pulsatility index at first visit and 10 days after recieving treatment and at delivery.
Neonatal birth weight	4 months June 2019 till October 2019	Neonatal birth weight in kilograms

Trial Locations

Locations (1)

Kasralainy hospital; 🇪🇬 Giza, Egypt