NCT06871917

Brief Summary

study the relationship between maternal iron deficiency (ID) and/or iron deficiency anemia (IDA) to neonatal hemoglobin concentration and iron stores at birth

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jun 2025Apr 2027

First Submitted

Initial submission to the registry

March 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 8, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

March 7, 2025

Last Update Submit

May 20, 2025

Conditions

Keywords

anemia iron deficiency iron stores

Outcome Measures

Primary Outcomes (1)

  • Evaluation the effect of maternal iron deficiency (ID) and/or iron deficiency anemia (IDA) to fetal haemoglobin concentration and fetal iron stores.

    evaluation the correlation between ID and IDA in maternal and neonatal samples

    2 years

Secondary Outcomes (2)

  • -Prevalence of maternal iron deficiency and/or iron deficiency anemia at birth in our community.

    2 years

  • -Effect of maternal iron deficiency and/or iron deficiency anemia on early neonatal outcome .

    2 years

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study will include all pregnant women meet the inclusion criteria and their infant pairs at the time of delivery.

You may qualify if:

  • All pregnant women and their infant pairs who have given consent to participate.
  • Mothers Age: 21-40 years' old.
  • Term infants (37-42 weeks of gestation) with birth weight ≥2500 g born to mothers who had an uncomplicated normal singleton vaginal delivery or caesarian section delivery was included.

You may not qualify if:

  • Mothers with a history of antepartum hemorrhage, pre-mature labor pain, high-risk pregnancy (eg. history of trauma and severe infection during pregnancy), severe hyperemesis, pre-eclampsia severe anemia requiring blood transfusion, and any chronic medical illnesses as: gestational diabetes, hypertension, hypothyroidism, epilepsy, liver disease, renal disease cardiorespiratory disease, immunodeficiency syndrome, and hematological (other causes of anemia)
  • infants who suspected with congenital and/or chromosomal anomalies and pathological jaundice, also multiple pregnancy was excluded from the study.
  • Mothers withdrew from given a written consent will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naglaa Ali Ali

Asyut, Egypt

Location

Related Publications (7)

  • Krafft A, Huch R, Breymann C. Impact of parturition on iron status in nonanaemic iron deficiency. Eur J Clin Invest. 2003 Oct;33(10):919-23. doi: 10.1046/j.1365-2362.2003.01244.x.

    PMID: 14511365BACKGROUND
  • Bentley DP. Iron metabolism and anaemia in pregnancy. Clin Haematol. 1985 Oct;14(3):613-28.

    PMID: 3907911BACKGROUND
  • Mei Z, Cogswell ME, Looker AC, Pfeiffer CM, Cusick SE, Lacher DA, Grummer-Strawn LM. Assessment of iron status in US pregnant women from the National Health and Nutrition Examination Survey (NHANES), 1999-2006. Am J Clin Nutr. 2011 Jun;93(6):1312-20. doi: 10.3945/ajcn.110.007195. Epub 2011 Mar 23.

    PMID: 21430118BACKGROUND
  • Scholl TO. Iron status during pregnancy: setting the stage for mother and infant. Am J Clin Nutr. 2005 May;81(5):1218S-1222S. doi: 10.1093/ajcn/81.5.1218.

    PMID: 15883455BACKGROUND
  • Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.

    PMID: 18297894BACKGROUND
  • Delaney KM, Guillet R, Fleming RE, Ru Y, Pressman EK, Vermeylen F, Nemeth E, O'Brien KO. Umbilical Cord Serum Ferritin Concentration is Inversely Associated with Umbilical Cord Hemoglobin in Neonates Born to Adolescents Carrying Singletons and Women Carrying Multiples. J Nutr. 2019 Mar 1;149(3):406-415. doi: 10.1093/jn/nxy286.

    PMID: 30770543BACKGROUND
  • Bernhardt GV, Jhancy M, Shivappa P, Bernhardt K, Pinto JRT. Relationship between maternal and cord blood iron status in women and their new born pairs. Vol. 14, Biomedical and Pharmacology Journal. 2021. p. 317-22.

    BACKGROUND

Study Officials

  • Dalia G. Mahran, prof

    prof of public health and community medicine, Faculty of medicine, Assuit university

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer at family medicine department AUH

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 12, 2025

Study Start

June 8, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations