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

NCT ID: NCT02420743

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2021-07-31

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.

Conditions

Preterm Delivery

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

serum ferritin

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

Intervention Type: PROCEDURE

MCA Doppler

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Nesreen Abdel Fattah Abdullah Shehata

Lecturer of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nesreen A Shehata, MD

Role: STUDY_DIRECTOR

Beni-Suef University

Locations

Nesreen Abdel Fattah Abdullah Shehata

Cairo, Fostat, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nesreen A Shehata, MD

Role: CONTACT

nesoomar@yahoo.com

00201024150605 ext. 02

Abdelgany M Hassan, MD

Role: CONTACT

abdelgany2@gmail.com

00201017801604 ext. 02

Facility Contacts

Nesreen A Shehata, MD

Role: primary

nesoomar@yahoo.com

00201227866337 ext. 02

Abdelgany M Hassan, MD

Role: backup

abdelgany2@gmail.com

00201017801604 ext. 02

References

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.

Reference Type: BACKGROUND

PMID: 9829872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10620643 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35172391 (View on PubMed)

Royal college of obstetricians and gynecologists. Preterm Prelabour Rupture of Membranes. Green-top Guideline No. 44. London: RCOG Press; 2010.

Reference Type: RESULT

Other Identifiers

Beni-Suef 10

Identifier Type: -

Identifier Source: org_study_id