Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT06252103
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Procedures:
All patients will undergo the following:
Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.
1. History taking:
* Personal history: name, age, occupation and address.
* Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration.
* Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin.
2. Medical examination:
* General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill)
* Abdominal examination to assess fundal height.
3. Investigations to perform will include:
Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.
Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.
Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.
All patients will undergo the following:
Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.
1. History taking:
* Personal history: name, age, occupation and address.
* Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration.
* Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin.
2. Medical examination:
* General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill)
* Abdominal examination to assess fundal height.
3. Investigations to perform will include:
Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.
Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.
Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.
Detailed Description:
This study included two groups:
Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.
Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.
Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: