Clinical trial NCT02420743: Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery
Official title: Third Trimester Serum Ferritin Concentration and Fetal MCA Peak Systolic Velocity as Predictors for Preterm Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Delivery
Keywords: PTD
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2015-04-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant females during third trimester. Women should be diagnosed as having iron deficiency anemia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: High serum ferritin concentration
timeFrame: at 26 to 34 weeks gestation
Secondary outcomes:
measure: PSV in fetal MCA doppler
timeFrame: 26 to 34 weeks gestation
measure: Preterm delivery
timeFrame: From 34 to 37 weeks gestation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nesreen Abdel Fattah Abdullah Shehata
state: Fostat
Study officials:
affiliation: Beni-Suef University
name: Nesreen A Shehata, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1093/oxfordjournals.aje.a009577.
citation: 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. doi: 10.1056/NEJM200001063420102.
citation: Stock SJ, Thomson AJ, Papworth S; Royal College of Obstetricians and Gynaecologists. Antenatal corticosteroids to reduce neonatal morbidity and mortality: Green-top Guideline No. 74. BJOG. 2022 Jul;129(8):e35-e60. doi: 10.1111/1471-0528.17027. Epub 2022 Feb 16. No abstract available.
citation: Royal college of obstetricians and gynecologists. Preterm Prelabour Rupture of Membranes. Green-top Guideline No. 44. London: RCOG Press; 2010.