Maternal Serum Ferritin and Low Neonatal Birth Weight

NCT02738463 | Unknown DMC

• 1 other identifier: SHMS1985
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 2

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

Conditions

IUGR

Keywords

ferritin LBW

Outcome Measures

Primary Outcomes (2)

• maternal serum ferritin (microg/L)

  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 months

• Fetal weight (gm)

  birth weight less than 10th percentile will be adjusted for small for gestational age

  5 minutes

Secondary Outcomes (4)

• Maternal hemoglobin (g/L)

  2 months

• Maternal hematocrit (x10^12/L)

  2 months

• Apgar score

  5 minutes

• Maternal total leucocytic count (x10^9/L)

  2 months

Study Arms (2)

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)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead
• Ain Shams University: collaborator

Study Sites (2)

Ain Shams Maternity Hospital

Cairo, Cairo Governorate, 11566, Egypt

Location

outpatient clinics in the Obstetrics and Gynecology Department Ain Shams Maternity Hospital

Cairo, Cairo Governorate, 11566, Egypt

Location

Related Publications (10)

• Arosio P, Ingrassia R, Cavadini P. Ferritins: a family of molecules for iron storage, antioxidation and more. Biochim Biophys Acta. 2009 Jul;1790(7):589-99. doi: 10.1016/j.bbagen.2008.09.004. Epub 2008 Sep 26.

  PMID: 18929623 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Moh W, Graham JM Jr, Wadhawan I, Sanchez-Lara PA. Extrinsic factors influencing fetal deformations and intrauterine growth restriction. J Pregnancy. 2012;2012:750485. doi: 10.1155/2012/750485. Epub 2012 Jul 19.

  PMID: 22888434 BACKGROUND

• Murki S and Sharma D. Intrauterine Growth Retardation - A Review Article. Murki and Sharma, J Neonatal Biol 2014, 3:3

  BACKGROUND

• 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

  BACKGROUND

• Muhammad T, Khattak AA, Shafiq-ur-Rehman, Khan MA, Khan A, Khan MA. Maternal factors associated with intrauterine growth restriction. J Ayub Med Coll Abbottabad. 2010 Oct-Dec;22(4):64-9.

  PMID: 22455264 BACKGROUND

• 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

  BACKGROUND

• Wang CN, Chang SD, Peng HH, Lee YS, Chang YL, Cheng PJ, Chao AS, Wang TH, Wang HS. Change in amniotic fluid levels of multiple anti-angiogenic proteins before development of preeclampsia and intrauterine growth restriction. J Clin Endocrinol Metab. 2010 Mar;95(3):1431-41. doi: 10.1210/jc.2009-1954. Epub 2010 Jan 15.

  PMID: 20080845 BACKGROUND

• Zhang S, Regnault TR, Barker PL, Botting KJ, McMillen IC, McMillan CM, Roberts CT, Morrison JL. Placental adaptations in growth restriction. Nutrients. 2015 Jan 8;7(1):360-89. doi: 10.3390/nu7010360.

  PMID: 25580812 BACKGROUND

Related Links

• Ross MG. Fetal growth restriction, 2008

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

• Hassan A Bayoumyi, MD

  Ain Shams University

  STUDY CHAIR

• Sherif A Ashoush, MD

  Ain Shams University

  STUDY DIRECTOR

• Haitham AM ElSabaa, MD

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (2)