Iron DeficiencyNCT05262634
Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester
An observational study of Iron Deficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The primary aim of this retrospective, monocentric study with two parallel groups is to investigate pregnancy outcome in women with iron deficiency in the first trimester. It compares the pregnancy outcome between pregnant women with an iron deficiency and those without an iron deficiency in the first trimester. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Data collection (laboratory and obstetric results)
- How many people
- 713 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2021to 31 Jan 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The data comes from the patient files of pregnant women who were treated in the Polyclinic Women's Clinic University Hospital Basel between 2017 and 2019.
Who may be able to join
- Pregnant women with a documented iron deficiency in the first trimester
- Pregnant women with normal hematological parameters and iron status in the first trimester
- Treated at the Women's Clinic, University Hospital in Basel
Who cannot join
- Pregnant women with a documented rejection
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this retrospective, monocentric study with two parallel groups is to investigate pregnancy outcome in women with iron deficiency in the first trimester. It compares the pregnancy outcome between pregnant women with an iron deficiency and those without an iron deficiency in the first trimester. The study group are pregnant women with a diagnosed iron deficiency in the first trimester, a total of 227 pregnant women. The control group consists of 486 pregnant women without first-trimester iron deficiency. Matching criteria include parity and maternal age. Data from patient files of pregnant women who were treated in the Women's Clinic, University Hospital Basel between 2017 and 2019 are analyzed.
- Conditions
- Iron Deficiency
- Being tested
- Data collection (laboratory and obstetric results)
- Keywords
- iron deficiency anemia of pregnancy, pregnancy outcome, perinatal risk, maternal risk
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection (laboratory and obstetric results)Other
Maternal data: age, pregnancy, parity, singleton or multiple pregnancy, BMI, obstetric history data, and ethnicity.
Laboratory chemical results: hemoglobin (Hb), number of erythrocytes, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), number of hypochromic erythrocytes (HRC), erythrocyte distribution width (EBW), ferritin, C reactive protein (CRP).
Maternal pregnancy outcomes and complications: Hb before and after delivery, mode of delivery, placenta abruption, preeclampsia/eclampsia, gestational diabetes, gestational cholestasis, pregnancy-induced hypertension, bacteriuria or urinary tract infections, peripartum and postpartum hemorrhage, puerperal infections, uterine subinvolution.
Perinatal outcomes: gestational age, birth weight, intrauterine growth retardation, preterm birth, macrosomia, premature rupture of membranes, Apgar score, intrauterine fetal death, pH values, admission to neonatology
| Study group | Role | What they receive |
|---|---|---|
| study group: iron deficiency | Pregnant women with a documented iron deficiency in the first trimester Receives: Other: Data collection (laboratory and obstetric results) | |
| control group: normal iron status | Pregnant women with normal hematological parameters and iron status in the first trimester Receives: Other: Data collection (laboratory and obstetric results) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of anemia
Proportion of anemia in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester
Measured: one time assessment at baseline
Proportion of hemorrhage
Proportion of hemorrhage in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester
Measured: one time assessment at baseline
Proportion of growth retardation
Proportion of growth retardation in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Retrospective
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Hoesli, Prof. Dr. med., Study director, Women's Clinic, University Hospital BaselGabriela Amstad Bencaiova, Dr. med., Principal investigator, Women's Clinic, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262634
- Sponsor's protocol ID
- 2020-02033; bb22Hoesli2
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester
- ClinicalTrials.gov ID
- NCT05262634
- Acronym / sponsor ID
- 2020-02033; bb22Hoesli2
- Conditions
- Iron Deficiency
- Keywords
- iron deficiency anemia of pregnancy, pregnancy outcome, perinatal risk, maternal risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 2 Mar 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.
The primary aim of this retrospective, monocentric study with two parallel groups is to investigate pregnancy outcome in women with iron deficiency in the first trimester. It compares the pregnancy outcome between pregnant women with an iron deficiency and those without an iron deficiency in the first trimester. The study group are pregnant women with a diagnosed iron deficiency in the first trimester, a total of 227 pregnant women. The control group consists of 486 pregnant women without first-trimester iron deficiency. Matching criteria include parity and maternal age. Data from patient files of pregnant women who were treated in the Women's Clinic, University Hospital Basel between 2017 and 2019 are analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group: iron deficiency | – | Other: Data collection (laboratory and obstetric results)Pregnant women with a documented iron deficiency in the first trimester |
| control group: normal iron status | – | Other: Data collection (laboratory and obstetric results)Pregnant women with normal hematological parameters and iron status in the first trimester |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The data comes from the patient files of pregnant women who were treated in the Polyclinic Women's Clinic University Hospital Basel between 2017 and 2019.
Key inclusion criteria (3 listed)
- Pregnant women with a documented iron deficiency in the first trimester
- Pregnant women with normal hematological parameters and iron status in the first trimester
- Treated at the Women's Clinic, University Hospital in Basel
Key exclusion criteria (1 listed)
- Pregnant women with a documented rejection
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 |
|---|---|---|
| Data collection (laboratory and obstetric results)Maternal data: age, pregnancy, parity, singleton or multiple pregnancy, BMI, obstetric history data, and ethnicity. Laboratory chemical results: hemoglobin (Hb), number of erythrocytes, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), number of hypochromic erythrocytes (HRC), erythrocyte distribution width (EBW), ferritin, C reactive protein (CRP). Maternal pregnancy outcomes and complications: Hb before and after delivery, mode of delivery, placenta abruption, preeclampsia/eclampsia, gestational diabetes, gestational cholestasis, pregnancy-induced hypertension, bacteriuria or urinary tract infections, peripartum and postpartum hemorrhage, puerperal infections, uterine subinvolution. Perinatal outcomes: gestational age, birth weight, intrauterine growth retardation, preterm birth, macrosomia, premature rupture of membranes, Apgar score, intrauterine fetal death, pH values, admission to neonatology | Other | control group: normal iron status, study group: iron deficiency |
Primary outcome
Proportion of anemia
Time frame: one time assessment at baseline
Proportion of anemia in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester
Proportion of hemorrhage
Time frame: one time assessment at baseline
Proportion of hemorrhage in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester
Proportion of growth retardation
Time frame: one time assessment at baseline
Proportion of growth retardation in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester
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 2 Mar 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.
Irene Hoesli, Prof. Dr. med. study director
Women's Clinic, University Hospital Basel
Gabriela Amstad Bencaiova, Dr. med. principal investigator
Women's Clinic, University Hospital Basel
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, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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 2 Mar 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 Switzerland. 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?
Proportion of anemia (time frame: one time assessment at baseline). The study lists 3 primary outcomes in all. 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 2 Mar 2022.