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

• Conditions: Preterm Delivery

• Registration Number: NCT02420743
• Lead Sponsor: Beni-Suef University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-04-11
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-30
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High serum ferritin concentration	at 26 to 34 weeks gestation	The investigators will assess high serum ferritin concentration during third trimester and its effect on pregnancy outcome.

Secondary Outcome Measures

Name	Time	Method
PSV in fetal MCA doppler	26 to 34 weeks gestation	Peak systolic velocity of fetal MCA will be measured to diagnose fetal anemia and if correlated with preterm delivery.
Preterm delivery	From 34 to 37 weeks gestation	The investigators will assess pregnancy outcome in the form og preterm delivery with abnormal parameters in the study.

Trial Locations

Locations (1)

Nesreen Abdel Fattah Abdullah Shehata; 🇪🇬 Cairo, Fostat, Egypt