Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement

NCT02957643 | Completed Phase 1

• 1 other identifier: HippokratioGH
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment.

Conditions

Prevention of Anemia

Outcome Measures

Primary Outcomes (1)

• Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire

  Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant

  up to 24 months

Secondary Outcomes (1)

• adverse reactions

  up to 24 months

Study Arms (2)

pregnant women

PLACEBO COMPARATOR

iron dosage 1 per day for 3 months

Drug: Iron

pregnant women with anemia

EXPERIMENTAL

iron dosage 1 per day for 6 months

Drug: Iron

Interventions

Iron DRUG

oral treatment

Also known as: oral iron

pregnant women; pregnant women with anemia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age more or equal of 18 years
• Registration consent
• Have complete 12h week of pregnancy
• Hemoglobin levels \<10,5 ptl
• Hematocrit \< 32 %

You may not qualify if:

• Age \<18 years
• Absent registration consent
• Step of pregnancy less than 12 weeks
• Coadministration formulations iron oral or parenterally
• Background of liver kirrosis
• Background of aimosidirosis
• Background acquired or chronic aimatochromatosis
• Aplastic , Hemolytic anemia and chronic diseases
• Chronic pancreatitis
• Subjective renal or/and liver disease
• Hypothyroidism or yperthyreoeidismos

Sponsors & Collaborators

• Hippocration General Hospital: lead

MeSH Terms

Interventions

Iron

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• PANAGIOTIS MATSOUKATIDIS, MD,Msc

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

• CHARALABOS KOLVATZIS, MD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of obstetrics and gynaecology A.U.TH.

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: up to two years upon completion
• Access Criteria: email contact