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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02420743
Acronym
SFMCA
Enrollment
100
Registered
2015-04-20
Start date
2014-10-31
Completion date
2021-07-31
Last updated
2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Delivery

Keywords

PTD

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.

Interventions

serum ferritin will be measured serially at 26, 30 and 34 weeks gestation.

PROCEDUREMCA Doppler

MCA peak systolic value will be assessed at 26, 30 and 34 weeks gestation.

Sponsors

Cairo University
CollaboratorOTHER
Beni-Suef University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
High serum ferritin concentrationat 26 to 34 weeks gestationThe investigators will assess high serum ferritin concentration during third trimester and its effect on pregnancy outcome.

Secondary

MeasureTime frameDescription
PSV in fetal MCA doppler26 to 34 weeks gestationPeak systolic velocity of fetal MCA will be measured to diagnose fetal anemia and if correlated with preterm delivery.
Preterm deliveryFrom 34 to 37 weeks gestationThe investigators will assess pregnancy outcome in the form og preterm delivery with abnormal parameters in the study.

Countries

Egypt

Contacts

Primary ContactNesreen A Shehata, MD
nesoomar@yahoo.com00201024150605
Backup ContactAbdelgany M Hassan, MD
abdelgany2@gmail.com00201017801604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026