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Maternal Serum Ferritin and Low Neonatal Birth Weight (LBW)

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ClinicalTrials.gov Identifier: NCT02738463
Recruitment Status : Unknown
Verified April 2016 by Shaimaa Mahmoud salem, Ain Shams Maternity Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Shaimaa Mahmoud salem, Ain Shams Maternity Hospital

Brief Summary:
Intrauterine growth restriction ( IUGR )is defined as fetal growth slower than the normal growth potential of a specific fetus because of genetic or environmental factors. Recently several studies have highlighted the role of many biomolecules as markers for IUGR. Measurement of maternal serum ferritin has also been used as a predictive marker for increased risk of IUGR. Iron deficiency has its known deleterious effect in pregnancy but iron loading may be associated with oxidative damage to cells and tissues. It has been shown in various studies that lower level of transferritin receptor expression in placenta is associated with preeclampsia and IUGR. This can lead to decrease extraction of iron by placenta from maternal serum leading to increase maternal serum ferritin. This fetal iron deficiency leads to increase in fetal corticotropins and fetal cortisol, causing inhibition of fetal growth

Condition or disease
IUGR

Detailed Description:

Intrauterine growth restriction (IUGR) is defined as fetal growth slower than the normal growth potential of a specific fetus because of genetic or environmental factors. IUGR is associated with a high incidence of perinatal morbidity and mortality. IUGR neonates have a greater risk of hypoxic ischemic encephalopathy, intraventricular hemorrhage and necrotizing enterocolitis with longer hospital stay and higher health care costs. Incidence of a fetus developing a small size for gestational age is about 8%. Fetal growth is regulated by the balance between fetal nutrient demand and maternal placental nutrient supply. Intrauterine growth restriction may be caused by maternal, placental, or fetal factors. Nearly one-third of IUGRs are due to genetic causes, and two-thirds are related to the fetal environment. In the developing world, IUGR is likely to be a consequence of poor maternal nutritional status prior to or during pregnancy.

There are two general patterns of growth abnormalities: symmetric and asymmetric. Symmetric growth inhibition arises during the first half of gestation, when fetal growth occurs primarily through cellular division and produces an undersized fetus with fewer cells of normal size. Asymmetric growth inhibition occurs during the second half of gestation and is usually the consequence of an inadequate availability of substrates for fetal metabolism. To prevent the previously mentioned complications of IUGR, it is important to establish markers which can identify pregnancies at risk of IUGR early enough. Recently several studies have highlighted the role of many bio-molecules as markers for IUGR like leptin, adiponectin, endothelin-1, lactate dehydrogenase, s-endoglin, pregnancy associated plasma protein, metastin. Apart from being expensive, laboratories at majority of centers are not equipped with facilities of measurement of these markers. Measurement of maternal serum ferritin has also been used as a predictive marker for increased risk of IUGR in one previous study on a limited number (seventeen) of cases. Ferritin is an intracellular protein consisting of 24 heavy and light sub-units surrounding a core that can store up to 4,500 iron atoms. The two sub-units are highly conserved during evolution, but only the heavy sub-unit has ferroxidase activity. Ferritin is released by infiltrating leukocytes, in response to acute and chronic infection. Ferritin as an acute phase reactant is well known for its intracellular iron sequestration and storage abilities during immune activation. Serum ferritin concentration is positively correlated with the amount of total body iron stores in the absence of inflammation. Serum ferritin is considered a valuable bio-marker for body iron status in healthy subjects.Iron deficiency has its known deleterious effect in pregnancy but iron loading may be associated with oxidative damage to cells and tissues. It has been shown in various studies that lower level of transferritin receptor expression in placenta is associated with preeclampsia and IUGR. This can lead to decrease extraction of iron by placenta from maternal serum leading to increase maternal serum ferritin. This fetal iron deficiency leads to increase in fetal corticotropins and fetal cortisol, causing inhibition of fetal growth.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 64 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Role of Maternal Serum Ferritin in the Prediction of Low Neonatal Birth Weight
Study Start Date : March 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1 case
This group will include 32 pregnant females whose fetuses show intrauterine growth restriction at full term ( the 32 neonates with birth weight less than 10th percentile for corresponding gestational age will be included as small for gestational age and the investigator will thaw their maternal frozen samples for detection of serum ferritin level)
Group 2 control
This group will include at least 32 pregnant females whose fetuses are appropriate for gestational age at full term ( the 32 neonates with birth more than or equal to the 10th percentile for corresponding gestational age will be included as average for gestational age and the investigator will thaw their maternal frozen samples for detection of serum ferritin level)



Primary Outcome Measures :
  1. maternal serum ferritin (microg/L) [ Time Frame: 2 months ]
    Ferritin values will be estimated by immunometric testing for quantitative determination in human serum at Olympus analyzers using the Olympus ferritin reagent. Reference ranges from 10.00 to 30.00 microgram/L

  2. Fetal weight (gm) [ Time Frame: 5 minutes ]
    birth weight less than 10th percentile will be adjusted for small for gestational age


Secondary Outcome Measures :
  1. Maternal hemoglobin (g/L) [ Time Frame: 2 months ]
    estimation will be done from hemolysate of the obtained blood samples with the addition of sodium ferricyanide and sodium cyanide. Cyanmet -hemoglobin formed in the solution will be estimated by spectro photometry at the wave length of 540 nm.

  2. Maternal hematocrit (x10^12/L) [ Time Frame: 2 months ]
    The level will be also estimated by spectro photometry and calculated using the following formula: Hematocrit = blood cells volume/volume of blood sample × 100.

  3. Apgar score [ Time Frame: 5 minutes ]
    will be estimated by cardiac action, respiration of the newborn, muscle tone, skin color and reaction of the newborn will be estimated by 0, 1 or 2 summed up and compared. Apgar score can vary from 0 to 10.

  4. Maternal total leucocytic count (x10^9/L) [ Time Frame: 2 months ]
    will be also estimated also by spectro photometry


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study will include women, who attend the Obstetrics Department, in Ain Shams University Hospital, and fulfill the inclusion criteria, after taking an informed consent
Criteria

Inclusion Criteria:

  • Older than 20 years of age
  • Pregnant with singleton intrauterine pregnancy
  • 30th-32nd weeks of gestation

Exclusion Criteria:

  • Patients with a history of anemia due to any causes.
  • Patients with history of iron supplementation, Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities.
  • History of acid-peptic disorders, esophagitis, or hiatal hernia.
  • Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
  • Antepartum hemorrhage.
  • Allergies to milk proteins / hypersensitivity to iron preparations.
  • Patients with acute infection, positive CRP, raised TLC count.
  • Congenital malformation and fetuses with chromosomal or genetic syndrome.
  • Recent blood transfusion.
  • Refusal to participate in the study.
  • BMI <18.
  • Placental abnormalities like velamentous insertion.
  • Multiple pregnancies.
  • Smoking during pregnancy
  • Preterm births.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738463


Locations
Egypt
Ain Shams Maternity Hospital
Cairo, Egypt, 11566
outpatient clinics in the Obstetrics and Gynecology Department Ain Shams Maternity Hospital
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams Maternity Hospital
Ain Shams University
Investigators
Study Chair: Hassan A Bayoumyi, MD Ain Shams University
Study Director: Sherif A Ashoush, MD Ain Shams University
Study Director: Haitham AM ElSabaa, MD Ain Shams University

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications:
Bindal N, Godha Z, Kohli R, Kadam VK. Role of maternal serum ferritin as a predictive marker in intrauterine growth restriction. Int J Reprod Contracept Obstet Gynecol. 2015 Jun;4(3):804-808
Milman N. Iron Deficiency and Anaemia in Pregnant Women in Malaysia - Still a Significant and Challenging Health Problem. J Preg Child Health 2015, 2:3
Murki S and Sharma D. Intrauterine Growth Retardation - A Review Article. Murki and Sharma, J Neonatal Biol 2014, 3:3
Nandini M D, Shetty HV, Rupakala BV, Usha S M R, Priyadarshini KS, Manjula HS and Victoria Ksh. Study of serum ferritin levels in preterm labor. International Journal of Recent Trends in Science and Technology, ISSN 2277-2812 E-ISSN 2249-8109, Volume 14, Issue 2, 2015 pp 477-480
Višnjevac N, Segedi LM, Ćurčić A, Višnjevac J, Dragan Stajić. Blood ferritin levels in pregnant women and prediction of the development of fetal intrauterine growth restriction. J Med Biochem. 2011;30:m317-22

Responsible Party: Shaimaa Mahmoud salem, principal investigator, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02738463     History of Changes
Other Study ID Numbers: SHMS1985
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Shaimaa Mahmoud salem, Ain Shams Maternity Hospital:
ferritin LBW

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms