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

January 30, 2021 updated by: Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Fostat
      • Cairo, Fostat, Egypt, 12412
        • Recruiting
        • Nesreen Abdel Fattah Abdullah Shehata
        • Principal Investigator:
          • Nesreen A Shehata, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Abdelgany M Hassan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant females during third trimester. Women should be diagnosed as having iron deficiency anemia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High serum ferritin concentration
Time Frame: at 26 to 34 weeks gestation
The investigators will assess high serum ferritin concentration during third trimester and its effect on pregnancy outcome.
at 26 to 34 weeks gestation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Collaborators

Cairo University

Investigators

  • Study Director: Nesreen A Shehata, MD, Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

April 11, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 30, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beni-Suef 10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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