Brief Summary

Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is one of the most common complications during pregnancy. Anemia in pregnancy is defined as a hemoglobin level \< 110 g/L . Anemia is an important risk factor in pregnancy which leads to both maternal and fetal morbidity and mortality. The pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to cover their increased need. The pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries. Obesity is defined as having an excessive amount of body fat. The body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. There is an increased rate of overweight and obesity among pregnant women. According to the World Health Organization, 46% of adult females in Egypt are obese. Many researches in the literature revealed a strong relationship between high BMI in pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body. Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.

Trial Health

On Track

Trial Health Score

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

Enrollment

230

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

September 22, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed

7 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed

Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

September 22, 2019

Last Update Submit

May 3, 2022

Conditions

Anemia of Pregnancy

Outcome Measures

Primary Outcomes (1)

The number of anemic women at time of delivery
6 months

Secondary Outcomes (4)

The mean level of maternal Hemoglobin at 37-38 weeks .
6 months
The incidence of patients' reported side effect
6 months
The difference in serum ferritin
6 months
The difference in serum hepcidin
6 months

Study Arms (2)

Group I: 27 mg elemental iron

ACTIVE COMPARATOR

will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

Drug: IronDiagnostic Test: Complete blood countDiagnostic Test: Serum ferritinDiagnostic Test: Serum hepcidinDiagnostic Test: Serum IronDiagnostic Test: Serum total iron binding capacity

Group II: 54 mg elemental iron

ACTIVE COMPARATOR

will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks

Drug: IronDiagnostic Test: Complete blood countDiagnostic Test: Serum ferritinDiagnostic Test: Serum hepcidinDiagnostic Test: Serum IronDiagnostic Test: Serum total iron binding capacity