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UnknownNCT02420743

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Beni-Suef University · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREserum ferritinserum ferritin will be measured serially at 26, 30 and 34 weeks gestation.
PROCEDUREMCA DopplerMCA peak systolic value will be assessed at 26, 30 and 34 weeks gestation.

Timeline

Start date
2014-10-01
Primary completion
2021-07-01
Completion
2021-07-01
First posted
2015-04-20
Last updated
2021-02-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02420743. Inclusion in this directory is not an endorsement.