Iron Deficiency Anemia of PregnancyNCT05157828
Iron Deficiency Anaemia in Pregnant Patients Presenting for Antenatal Care
An observational study of Iron Deficiency Anemia of Pregnancy, run by University of Cape Town at 1 site in South Africa.
Trial summary
This is a cross-sectional, prospective study of iron deficiency anaemia among pregnant patients presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, over a one-week period. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- How many people
- 132 participants
- Where
- 1 siteSouth Africa
- Study dates
- 31 Jan 2022to 4 Feb 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will include all consenting patients presenting to the Antenatal Clinic at Mowbray Maternity Hospital, for antenatal care, during the one-week period of recruitment.
Who may be able to join
- All women presenting to the antenatal care services at Mowbray Maternity Hospital over the period of study recruitment.
- ≥ 18 years of age.
- Screen as anaemic (World Health Organisation <11g/dl) on bedside finger-prick haemoglobin.
- Who consent to participate.
Who cannot join
- Patients who refuse to participate, and those under the age of 18 years will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Mowbray maternity hospital
Cape Town, Western Cape, 7700
About this study
Official title: A Cross-sectional Prospective Study of the Prevalence of Iron Deficiency Anaemia in Pregnant Patients Presenting for Antenatal Care at a Secondary Level Institution, Mowbray Maternity Hospital
This is a cross-sectional, prospective study of iron deficiency anaemia among pregnant patients presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, over a one-week period.
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anaemia among all women presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, during a one-week period.
Proportion
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start31 Jan 2022
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christella Alphonsus, University of Cape Town
- Investigators
- Christella Alphonsus, MBChB, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157828
- Sponsor's protocol ID
- UCape Town
- Status last verified
- May 2022
- First submitted
- 29 Nov 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared by PI
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Prospective Study of the Prevalence of Iron Deficiency Anaemia in Pregnant Patients Presenting for Antenatal Care at a Secondary Level Institution, Mowbray Maternity Hospital
- ClinicalTrials.gov ID
- NCT05157828
- Acronym / sponsor ID
- UCape Town
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 15 Dec 2021 (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 is a cross-sectional, prospective study of iron deficiency anaemia among pregnant patients presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, over a one-week period.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include all consenting patients presenting to the Antenatal Clinic at Mowbray Maternity Hospital, for antenatal care, during the one-week period of recruitment.
Key inclusion criteria (4 listed)
- All women presenting to the antenatal care services at Mowbray Maternity Hospital over the period of study recruitment.
- ≥ 18 years of age.
- Screen as anaemic (World Health Organisation <11g/dl) on bedside finger-prick haemoglobin.
- Who consent to participate.
Key exclusion criteria (1 listed)
- Patients who refuse to participate, and those under the age of 18 years will be excluded from the study.
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Prevalence of anaemia among all women presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, during a one-week period.
Time frame: One week
Proportion
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 18 May 2022.
- Individual participant dataSharing planned: Yes. Data will be shared by PI
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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.
Christella Alphonsus, MBChB principal investigator
University of Cape Town
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 Iron Deficiency Anemia of Pregnancy, run by University of Cape Town at 1 site in South Africa.
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 4 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 18 May 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 South Africa. 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?
Prevalence of anaemia among all women presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, during a one-week period. (time frame: One week). 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 18 May 2022.