Anemia of PregnancyNCT05479799
Prevalence and Determinants of Anemia During the Third Trimester of Pregnancy
An observational study of Anemia of Pregnancy, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This cross-sectional study was conducted on 383 pregnant women who attended the antenatal care clinic during their third trimester at Beni-Suef University Hospital. A proper history was taken from each participant. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia of Pregnancy
- How many people
- 383 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2019to 30 Jun 2019
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study included pregnant women who attended the antenatal care clinic during their third trimester.
Who may be able to join
- pregnant women during their third trimester
Who cannot join
- Women with chronic medical illness
Trial locations and contacts
1 site in 1 country.
About this study
This cross-sectional study was conducted on 383 pregnant women who attended the antenatal care clinic during their third trimester at Beni-Suef University Hospital.
A proper history was taken from each participant. All women were subjected to routine antenatal care, including physical examinations, ultrasound examinations, and routine laboratory tests.
According to WHO criteria, anemia was diagnosed with a hemoglobin level of less than 11.0 g/dl. Anemia was further divided into three degrees; mild with hemoglobin level 10-10.9 g/dl, moderate with hemoglobin level 7-9.9 g/dl, and severe with hemoglobin level < 7.0 g/dl.
Read the detailed description
This cross-sectional study was conducted on 383 pregnant women who attended the antenatal care clinic during their third trimester at Beni-Suef University Hospital.
A proper history was taken from each participant regarding age, educational level, residency (urban or rural), occupation, family income, frequency of antenatal visits, obstetric history, medical history, and surgical history. Nutritional history is taken to detect the frequency intake of meat/month, chicken/week, fish/week, fruits/week, vegetables/week, and tea/day. History of iron supplements intake was taken. All women were subjected to routine antenatal care, including a physical examination (e.g., measuring blood pressure), ultrasound, and umbilical artery Doppler examination. A blood sample was taken from each enrolled woman for standard laboratory tests such as complete blood picture, blood group, RH type, and blood sugar test if there is a risk. A urine sample was taken for urine analysis. Blood from each participant was drawn from the cubital vein into appropriate blood collection tubes using vacuum tube needles (Becton Dickinson Medical Devices Co. Ltd., Franklin Lakes, USA). K2EDTA tubes were used for CBC. Samples were transported and tested within 4 hours after collection. Measured CBC parameters included RBC, HGB, HCT, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), MCH concentration (MCHC), platelet count (PLT), WBC, and WBC differentials, including percentages and absolute counts of neutrophils (NEUT% and NEUT), lymphocytes (LYM% and LYM), monocytes (MONO% and MONO), basophils (BASO% and BASO), and eosinophils (EO% and EO).
According to WHO criteria, anemia was diagnosed with a hemoglobin level of less than 11.0 g/dl. Anemia was further divided into three degrees; mild with hemoglobin level 10-10.9 g/dl, moderate with hemoglobin level 7-9.9 g/dl, and severe with hemoglobin level < 7.0 g/dl.
- Conditions
- Anemia of Pregnancy
- Keywords
- Anemia, Hemoglobin, Third trimester, Pregnancy outcome
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anemia group | anemia was diagnosed with a hemoglobin level of less than 11.0 g/dl | |
| Non-anemia group | Normal hemoglobin was diagnosed with a hemoglobin level of more than 11.0 g/dl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with the prevalence of anemia in the third trimester of pregnancy
Number of participants with the prevalence of anemia in the third trimester of pregnancy in a specific geographical area (Beni-Suef University Hospital as a tertiary referral center)
Measured: through study completion (3-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start4 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of PregnancyStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel-Tawab Mahmoud, MD, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479799
- Sponsor's protocol ID
- anemia in pregnancy: Beni-Suef
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Determinants of Anemia During the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT05479799
- Acronym / sponsor ID
- anemia in pregnancy: Beni-Suef
- Conditions
- Anemia of Pregnancy
- Keywords
- Anemia, Hemoglobin, Third trimester, Pregnancy outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 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.
This cross-sectional study was conducted on 383 pregnant women who attended the antenatal care clinic during their third trimester at Beni-Suef University Hospital.
A proper history was taken from each participant. All women were subjected to routine antenatal care, including physical examinations, ultrasound examinations, and routine laboratory tests.
According to WHO criteria, anemia was diagnosed with a hemoglobin level of less than 11.0 g/dl. Anemia was further divided into three degrees; mild with hemoglobin level 10-10.9 g/dl, moderate with hemoglobin level 7-9.9 g/dl, and severe with hemoglobin level < 7.0 g/dl.
Detailed description
This cross-sectional study was conducted on 383 pregnant women who attended the antenatal care clinic during their third trimester at Beni-Suef University Hospital.
A proper history was taken from each participant regarding age, educational level, residency (urban or rural), occupation, family income, frequency of antenatal visits, obstetric history, medical history, and surgical history. Nutritional history is taken to detect the frequency intake of meat/month, chicken/week, fish/week, fruits/week, vegetables/week, and tea/day. History of iron supplements intake was taken. All women were subjected to routine antenatal care, including a physical examination (e.g., measuring blood pressure), ultrasound, and umbilical artery Doppler examination. A blood sample was taken from each enrolled woman for standard laboratory tests such as complete blood picture, blood group, RH type, and blood sugar test if there is a risk. A urine sample was taken for urine analysis. Blood from each participant was drawn from the cubital vein into appropriate blood collection tubes using vacuum tube needles (Becton Dickinson Medical Devices Co. Ltd., Franklin Lakes, USA). K2EDTA tubes were used for CBC. Samples were transported and tested within 4 hours after collection. Measured CBC parameters included RBC, HGB, HCT, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), MCH concentration (MCHC), platelet count (PLT), WBC, and WBC differentials, including percentages and absolute counts of neutrophils (NEUT% and NEUT), lymphocytes (LYM% and LYM), monocytes (MONO% and MONO), basophils (BASO% and BASO), and eosinophils (EO% and EO).
According to WHO criteria, anemia was diagnosed with a hemoglobin level of less than 11.0 g/dl. Anemia was further divided into three degrees; mild with hemoglobin level 10-10.9 g/dl, moderate with hemoglobin level 7-9.9 g/dl, and severe with hemoglobin level < 7.0 g/dl.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anemia group | – | –anemia was diagnosed with a hemoglobin level of less than 11.0 g/dl |
| Non-anemia group | – | –Normal hemoglobin was diagnosed with a hemoglobin level of more than 11.0 g/dl |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study included pregnant women who attended the antenatal care clinic during their third trimester.
Key inclusion criteria (1 listed)
- pregnant women during their third trimester
Key exclusion criteria (1 listed)
- Women with chronic medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with the prevalence of anemia in the third trimester of pregnancy
Time frame: through study completion (3-6 months)
Number of participants with the prevalence of anemia in the third trimester of pregnancy in a specific geographical area (Beni-Suef University Hospital as a tertiary referral center)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anemia of Pregnancy, run by Beni-Suef 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: finished, as of the sponsor's last update on 29 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with the prevalence of anemia in the third trimester of pregnancy (time frame: through study completion (3-6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2022.