Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery

Preterm Delivery Clinical Trial

— SFMCA  

Official title:

Third Trimester Serum Ferritin Concentration and Fetal MCA Peak Systolic Velocity as Predictors for Preterm Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02420743
• Other study ID #: Beni-Suef 10
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery

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