The Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamic and Neonatal Outcome

NCT04016922 | Unknown

• 1 other identifier: Fetal hemodynamics, neonates
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to show the effect of different degrees of maternal iron deficiency anemia on fetal hemodynamics and neonatal outcome and to evaluate the effect of treatment.

Conditions

Fetal Conditions

Keywords

Fetal hemodynamics.; Intrauterine growth restriction; Amniotic fluid index

Outcome Measures

Primary Outcomes (2)

• Changes in fetal vascular doppler parameters.

  Fetal doppler parameters by resistance index and pulsatility index at first visit and 10 days after recieving treatment and at delivery.

  4 months from June 2019 till October 2019

• Neonatal birth weight

  Neonatal birth weight in kilograms

  4 months June 2019 till October 2019

Study Arms (3)

Group A

Patients with mild anemia (Hb concentration: 9.0-10.9 g\\dl).

Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C

Group B

Patients with moderate anemia (Hb concentration: 7.0-8.9 g\\dl).

Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C

Group C

Patients with severe anemia (Hb concentration: \>7.0 g\\dl).

Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C

Interventions

Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C OTHER

Consent, history. US: fetal heart activity, placental site, fetal biometry, AFI, anomalies, Doppler: umbilical artery, MCA, fetal renal artery, C\\U ratio. \* Maternal Hb,US at time of first visit, 10 days later after initiation of treatment, at EDD . * As part of routine medical care of these patients, they are managed as: A: give oral iron in the form of ferrous fumerate with the possible side effects. if Hb returns to normal, continue iron for 3 mon. B: admit to receive IV iron sucrose according to product literature allergic reaction may happen; antiallergic measures. C: give blood transfusion in the form of packed RBC. allergic and pyrogenic reaction and infection may occur. At delivery will be subjected to: examination, investigations, US.

Also known as: routine medical care

Group A; Group B; Group C

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

\* The pregnant women were divided into three groups: 1. Group A : Patients with mild anemia (Hb concentration: 9.0-10.9 g\\dl). 2. Group B : Patients with moderate anemia (Hb concentration: 7.0-8.9 g\\dl). 3. Group C : Patients with severe anemia (Hb concentration: \>7.0 g\\dl).

You may qualify if:

• Pregnant females aged 20- 35 years.
• Gestational age 32 weeks or more.
• Living singleton fetus.

You may not qualify if:

• Multifetal pregnancy.
• Patients with chronic illness or medical disorders other than iron deficiency anemia.
• Patients with history of recurrent perinatal deaths or recent blood transfusion or other vitamin deficiency anemia.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralainy hospital

Giza, Egypt

Location

Related Publications (5)

• Breymann C. Iron Deficiency Anemia in Pregnancy. Semin Hematol. 2015 Oct;52(4):339-47. doi: 10.1053/j.seminhematol.2015.07.003. Epub 2015 Jul 10.

  PMID: 26404445 BACKGROUND

• Abu-Ouf NM, Jan MM. The impact of maternal iron deficiency and iron deficiency anemia on child's health. Saudi Med J. 2015 Feb;36(2):146-9. doi: 10.15537/smj.2015.2.10289.

  PMID: 25719576 BACKGROUND

• Breymann C; Anaemia Working Group. [Current aspects of diagnosis and therapy of iron deficiency anemia in pregnancy]. Praxis (Bern 1994). 2001 Aug 2;90(31-32):1283-91. German.

  PMID: 11519193 BACKGROUND

• Lee AI, Okam MM. Anemia in pregnancy. Hematol Oncol Clin North Am. 2011 Apr;25(2):241-59, vii. doi: 10.1016/j.hoc.2011.02.001.

  PMID: 21444028 BACKGROUND

• Rasmussen K. Is There a Causal Relationship between Iron Deficiency or Iron-Deficiency Anemia and Weight at Birth, Length of Gestation and Perinatal Mortality? J Nutr. 2001 Feb;131(2S-2):590S-601S; discussion 601S-603S. doi: 10.1093/jn/131.2.590S.

  PMID: 11160592 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhamad Ehab, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mai Assistant lecturer

CONTACT

01153304548; maielsayed126@gmail.com

Ahmad Hamdi, lecturer

CONTACT

01001980841; A.hamdi15@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 12, 2019
• Study Start: July 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

EG (1)