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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02420743
Other study ID # Beni-Suef 10
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2014
Est. completion date July 2021

Study information

Verified date January 2021
Source Beni-Suef University
Contact Nesreen A Shehata, MD
Phone 00201024150605
Email nesoomar@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pregnant women with iron deficiency anemia during third trimester will be assessed for serum ferritin and peak systolic value for fetal middle cerebral artery to find out their correlation with preterm delivery.


Description:

Preterm delivery, defined as delivery before 37 weeks of completed gestation (259 days), is a major cause of neonatal morbidity and mortality. Despite extensive research, preterm birth still accounts for 5-10% of all deliveries in developed countries and rates are on the increase, including in the UK. While mortality associated with preterm delivery has declined due to use of antenatal steroids and improvements in neonatal intensive care, preterm babies still remain at risk of major complications. These include respiratory distress syndrome, necrotising enterocolitis, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and long-term cognitive and sensory impairment. Two major determinants for the mortality and morbidity of babies born preterm are gestation at delivery and birthweight. Prematurity therefore carries significant cost implications to both healthcare services and society in general. High hemoglobin along with anemia was examined in an observational study. At entry to care, which ranged between 6 and 8.4 wk gestation, women with hemoglobin levels exceeding 130g/L had a greater than twofold increase in risk of preterm delivery and infant low birth weight. Neither risk was statistically significant, however, because of the small numbers with high hemoglobin. Similarly, a concentration of the iron storage protein, ferritin, that is high for the third trimester of pregnancy is also associated with an increased risk for preterm and very preterm delivery. Over the last twenty years, interest has been shown in using ultrasound parameters or Doppler studies of fetal blood to assess fetal anaemia. Middle cerebral artery Doppler has taken over and has replaced amniocentesis as a screening test for fetal anaemia in high risk pregnancies.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Pregnant female from 24 weeks till 37 weeks gestation. - Patients diagnosed as iron deficiency anemia. Exclusion Criteria: - Medical disorders as hypertension or diabetes. - Kidney and liver diseases. - Any other causes of anemia as haemoglobinopathies.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
serum ferritin
serum ferritin will be measured serially at 26, 30 and 34 weeks gestation.
MCA Doppler
MCA peak systolic value will be assessed at 26, 30 and 34 weeks gestation.

Locations

Country Name City State
Egypt Nesreen Abdel Fattah Abdullah Shehata Cairo Fostat

Sponsors (2)

Lead Sponsor Collaborator
Beni-Suef University Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Mari G, Deter RL, Carpenter RL, Rahman F, Zimmerman R, Moise KJ Jr, Dorman KF, Ludomirsky A, Gonzalez R, Gomez R, Oz U, Detti L, Copel JA, Bahado-Singh R, Berry S, Martinez-Poyer J, Blackwell SC. Noninvasive diagnosis by Doppler ultrasonography of fetal anemia due to maternal red-cell alloimmunization. Collaborative Group for Doppler Assessment of the Blood Velocity in Anemic Fetuses. N Engl J Med. 2000 Jan 6;342(1):9-14. — View Citation

Royal college of obstetricians and gynecologists. Antenatal Corticosteroids to Reduce Neonatal Morbidity.Green-top Guideline No. 7. London: RCOG Press; 2010.

Royal college of obstetricians and gynecologists. Preterm Prelabour Rupture of Membranes. Green-top Guideline No. 44. London: RCOG Press; 2010.

Zhou LM, Yang WW, Hua JZ, Deng CQ, Tao X, Stoltzfus RJ. Relation of hemoglobin measured at different times in pregnancy to preterm birth and low birth weight in Shanghai, China. Am J Epidemiol. 1998 Nov 15;148(10):998-1006. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary High serum ferritin concentration The investigators will assess high serum ferritin concentration during third trimester and its effect on pregnancy outcome. at 26 to 34 weeks gestation
Secondary PSV in fetal MCA doppler Peak systolic velocity of fetal MCA will be measured to diagnose fetal anemia and if correlated with preterm delivery. 26 to 34 weeks gestation
Secondary Preterm delivery The investigators will assess pregnancy outcome in the form og preterm delivery with abnormal parameters in the study. From 34 to 37 weeks gestation
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