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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

Tracking Information
First Submitted Date March 31, 2016
First Posted Date April 14, 2016
Last Update Posted Date April 14, 2016
Study Start Date March 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2016)
  • 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
  • Fetal weight (gm) [ Time Frame: 5 minutes ]
    birth weight less than 10th percentile will be adjusted for small for gestational age
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 11, 2016)
  • 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.
  • 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.
  • 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.
  • Maternal total leucocytic count (x10^9/L) [ Time Frame: 2 months ]
    will be also estimated also by spectro photometry
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Maternal Serum Ferritin and Low Neonatal Birth Weight
Official Title Role of Maternal Serum Ferritin in the Prediction of Low Neonatal Birth Weight
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
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]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 2 Months
Biospecimen Retention:   Samples Without DNA
Description:
serum
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
Condition IUGR
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 11, 2016)
64
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT02738463
Other Study ID Numbers SHMS1985
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Shaimaa Mahmoud salem, Ain Shams Maternity Hospital
Study Sponsor Ain Shams Maternity Hospital
Collaborators 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
PRS Account Ain Shams Maternity Hospital
Verification Date April 2016