Pregnancy RelatedNCT05477914
Assesment of Knowledge,Attitude and Practice of Pregnant Women Regarding Iron,Folic Acid and Multivitamins at AlMonshah District.
An observational study of Pregnancy Related, run by Sohag University at 1 site in Egypt.
Trial summary
Anaemia is defined as the lack of functioning red blood cells (RBCs) that leads to a decrease in the ability to carry oxygen causing a lot of complications during life time. Iron deficiency anaemia is a main public health problem in all countries. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- questionnaire
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2022to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Adult
Study population: All pregnant women who are resident in Almonshah district, Sohag and attend the mentioned health centers for antenatal care services
Who may be able to join
- All pregnant women who are resident in Almonshah district, Sohag and attend the mentioned health centers for antenatal care services.
Who cannot join
- 1- Women who refuse to participate in the study. 2- Presence of pregnancy complications. 3- Presence of psychiatric or cognitive diseases
Trial locations and contacts
1 site in 1 country.
Fouad M Atia, professor contact
About this study
Anaemia is defined as the lack of functioning red blood cells (RBCs) that leads to a decrease in the ability to carry oxygen causing a lot of complications during life time.
Iron deficiency anaemia is a main public health problem in all countries. Over 30% of the world's population had anaemia; 4.3%-20% and 30%-48% respectively in developed and developing countries are affected by iron deficiency anaemia. Globally, it is estimated that roughly 38% of pregnant females, 29% non-pregnant women, and 29% of all females of reproductive age are diagnosed to have anaemia .
Read more
WHO suggested a standard daily dose of 30 to 60 mg of iron and 400 µg of folic acid supplements to prevent anaemia in pregnancy. This dose of iron and folic acid should be taken ideally before gestation with the earliest possible time and must be continued throughout the gestational period.
During pregnancy it is important to take adequate nutrition which is essential for optimal growth of the foetus and decrease in the incidence of congenital anomalies. adequate dietary intake of proteins and energy is not enough for normal weight of the new-born, decrease in vitamins and minerals can adversely affect the weight of the new- born .
The prevalence of neural tube defects, low-birth weights, small babies for gestational age and maternal anaemia can be reduced by adequate intake of iron and folic acid supplements during pregnancy. A lot of studies show the same positive results for the intake of multivitamins ,but iron and folic acid are the most important .
A lot of studies show the importance of the relationship between iron and folic acid supplement or multivitamins intake and the socio-economic factors as age, level of education, residence, marital status, parity, economic status, prenatal circumstances. There are association between more intake of supplements during pregnancy and a higher socioeconomic levels , level of education and use of prenatal medical services in studies conducted in Finland . The detection of anaemia in pregnancy is based on the examination of haemoglobin (Hb) levels at the first antenatal care visit.
If the haemoglobin level is <11.9%, the pregnant woman is declared anaemic and should be given supplements of 60 mg iron tablets and 0.5 mg folic acid. This supplement is taken regularly 1 tablet per day for 90 consecutive days. If the haemoglobin level is still <11.9%, then the administration of iron tablets is continued. However, in practice, not all pregnant women take tablets regularly. This could be due to inadequate knowledge about the importance of iron tablets for pregnancy.
- Conditions
- Pregnancy Related
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnare about nutritional knowledge of pregnant women
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge,Attitude and Practice of Pregnant Women Regarding Iron,Folic Acid and Multivitamins
using standradized questionnaire
Measured: 1 month after recruitment of the participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somia Saadeldin Abdelhafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477914
- Sponsor's protocol ID
- Soh-Med-22-07-03
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Popa AD, Nita O, Graur Arhire LI, Popescu RM, Botnariu GE, Mihalache L, Graur M. Nutritional knowledge as a determinant of vitamin and mineral supplementation during pregnancy. BMC Public Health. 2013 Dec 1;13:1105. doi: 10.1186/1471-2458-13-1105.
PubMed 24289203Arkkola T, Uusitalo U, Pietikainen M, Metsala J, Kronberg-Kippila C, Erkkola M, Veijola R, Knip M, Virtanen SM, Ovaskainen ML. Dietary intake and use of dietary supplements in relation to demographic variables among pregnant Finnish women. Br J Nutr. 2006 Nov;96(5):913-20. doi: 10.1017/bjn20061929.
PubMed 17092382
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Knowledge,Attitude and Practice of Pregnant Women Regarding Iron,Folic Acid and Multivitamins at AlMonshah District.
- ClinicalTrials.gov ID
- NCT05477914
- Acronym / sponsor ID
- Soh-Med-22-07-03
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anaemia is defined as the lack of functioning red blood cells (RBCs) that leads to a decrease in the ability to carry oxygen causing a lot of complications during life time.
Iron deficiency anaemia is a main public health problem in all countries. Over 30% of the world's population had anaemia; 4.3%-20% and 30%-48% respectively in developed and developing countries are affected by iron deficiency anaemia. Globally, it is estimated that roughly 38% of pregnant females, 29% non-pregnant women, and 29% of all females of reproductive age are diagnosed to have anaemia .
WHO suggested a standard daily dose of 30 to 60 mg of iron and 400 µg of folic acid supplements to prevent anaemia in pregnancy. This dose of iron and folic acid should be taken ideally before gestation with the earliest possible time and must be continued throughout the gestational period.
During pregnancy it is important to take adequate nutrition which is essential for optimal growth of the foetus and decrease in the incidence of congenital anomalies. adequate dietary intake of proteins and energy is not enough for normal weight of the new-born, decrease in vitamins and minerals can adversely affect the weight of the new- born .
The prevalence of neural tube defects, low-birth weights, small babies for gestational age and maternal anaemia can be reduced by adequate intake of iron and folic acid supplements during pregnancy. A lot of studies show the same positive results for the intake of multivitamins ,but iron and folic acid are the most important .
A lot of studies show the importance of the relationship between iron and folic acid supplement or multivitamins intake and the socio-economic factors as age, level of education, residence, marital status, parity, economic status, prenatal circumstances. There are association between more intake of supplements during pregnancy and a higher socioeconomic levels , level of education and use of prenatal medical services in studies conducted in Finland . The detection of anaemia in pregnancy is based on the examination of haemoglobin (Hb) levels at the first antenatal care visit.
If the haemoglobin level is <11.9%, the pregnant woman is declared anaemic and should be given supplements of 60 mg iron tablets and 0.5 mg folic acid. This supplement is taken regularly 1 tablet per day for 90 consecutive days. If the haemoglobin level is still <11.9%, then the administration of iron tablets is continued. However, in practice, not all pregnant women take tablets regularly. This could be due to inadequate knowledge about the importance of iron tablets for pregnancy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All pregnant women who are resident in Almonshah district, Sohag and attend the mentioned health centers for antenatal care services
Key inclusion criteria (1 listed)
- All pregnant women who are resident in Almonshah district, Sohag and attend the mentioned health centers for antenatal care services.
Key exclusion criteria (1 listed)
- 1- Women who refuse to participate in the study. 2- Presence of pregnancy complications. 3- Presence of psychiatric or cognitive diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnare about nutritional knowledge of pregnant women | Other | – |
Primary outcome
Knowledge,Attitude and Practice of Pregnant Women Regarding Iron,Folic Acid and Multivitamins
Time frame: 1 month after recruitment of the participants
using standradized questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 24289203Popa AD, Nita O, Graur Arhire LI, Popescu RM, Botnariu GE, Mihalache L, Graur M. Nutritional knowledge as a determinant of vitamin and mineral supplementation during pregnancy. BMC Public Health. 2013 Dec 1;13:1105. doi: 10.1186/1471-2458-13-1105.
- Background: PubMed 17092382Arkkola T, Uusitalo U, Pietikainen M, Metsala J, Kronberg-Kippila C, Erkkola M, Veijola R, Knip M, Virtanen SM, Ovaskainen ML. Dietary intake and use of dietary supplements in relation to demographic variables among pregnant Finnish women. Br J Nutr. 2006 Nov;96(5):913-20. doi: 10.1017/bjn20061929.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fouad M Atia, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact somaia S khalifa, resident (01062663823, somaia_saadeldien_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge,Attitude and Practice of Pregnant Women Regarding Iron,Folic Acid and Multivitamins (time frame: 1 month after recruitment of the participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477914, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.