IUGRLBWNCT02738463
Maternal Serum Ferritin and Low Neonatal Birth Weight
An observational study of IUGR, run by Ain Shams Maternity Hospital at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUGR
- How many people
- 64 participants
- Where
- 2 sitesEgypt
- Study dates
- Mar 2016to Sep 2016
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Older than 20 years of age
- Pregnant with singleton intrauterine pregnancy
- 30th-32nd weeks of gestation
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain Shams Maternity Hospital
Cairo, Cairo Governorate, 11566
outpatient clinics in the Obstetrics and Gynecology Department Ain Shams Maternity Hospital
Cairo, Cairo Governorate, 11566
About this study
Official title: Role of Maternal Serum Ferritin in the Prediction of Low Neonatal Birth Weight
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
Read the 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.
- Conditions
- IUGR
- Keywords
- ferritin LBW
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Fetal weight (gm)
birth weight less than 10th percentile will be adjusted for small for gestational age
Measured: 5 minutes
Secondary outcomes (4)
Maternal hemoglobin (g/L)
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.
Measured: 2 months
Maternal hematocrit (x10^12/L)
The level will be also estimated by spectro photometry and calculated using the following formula: Hematocrit = blood cells volume/volume of blood sample × 100.
Measured: 2 months
Apgar score
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.
Measured: 5 minutes
Maternal total leucocytic count (x10^9/L)
will be also estimated also by spectro photometry
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for IUGRStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Shaimaa Mahmoud salem, Ain Shams Maternity Hospital
- Investigators
- Hassan A Bayoumyi, MD, Study chair, Ain Shams UniversitySherif A Ashoush, MD, Study director, Ain Shams UniversityHaitham AM ElSabaa, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738463
- Sponsor's protocol ID
- SHMS1985
- Acronym
- LBW
- Status last verified
- Apr 2016
- First submitted
- 31 Mar 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 18929623Bindal 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
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.
PubMed 22888434Murki 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
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.
PubMed 22455264Višnjevac 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
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.
PubMed 20080845Zhang 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.
PubMed 25580812
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Maternal Serum Ferritin in the Prediction of Low Neonatal Birth Weight
- ClinicalTrials.gov ID
- NCT02738463
- Acronym / sponsor ID
- LBW / SHMS1985
- Conditions
- IUGR
- Keywords
- ferritin LBW
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- Older than 20 years of age
- Pregnant with singleton intrauterine pregnancy
- 30th-32nd weeks of gestation
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Maternal hemoglobin (g/L)
Time frame: 2 months
Maternal hematocrit (x10^12/L)
Time frame: 2 months
Apgar score
Time frame: 5 minutes
Maternal total leucocytic count (x10^9/L)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Background: PubMed 18929623Arosio 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.
- BackgroundBindal 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
- BackgroundMilman 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: PubMed 22888434Moh 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.
- BackgroundMurki S and Sharma D. Intrauterine Growth Retardation - A Review Article. Murki and Sharma, J Neonatal Biol 2014, 3:3
- BackgroundNandini 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: PubMed 22455264Muhammad 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.
- BackgroundVišnjevac 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: PubMed 20080845Wang 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.
- Background: PubMed 25580812Zhang 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.
- Ross MG. Fetal growth restriction, 2008Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan A Bayoumyi, MD study chair
Ain Shams University
Sherif A Ashoush, MD study director
Ain Shams University
Haitham AM ElSabaa, MD study director
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IUGR, run by Ain Shams Maternity Hospital at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal serum ferritin (microg/L) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02738463, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.