AnemiaNCT03792464
Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome
An observational study of Anemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to be overexpressed and correlated with low iron status. The increased hepcidin may restrain the iron release from the cells by affecting the expression of ferroportin, which probably associates with the development of diabetes… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Anemia
- How many people
- 188 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2019to 31 Oct 2021
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: 188 singleton pregnancies will be recruited in the first trimester at the University Hospital of Basel, Department of Obstetrics and Antenatal Care.
Who may be able to join
- women with a BMI ≥ 18.5 kg/m2,
- maternal age ≥ 18 years,
- singleton pregnancy,
- gestational age at recruitment: 11-14 of gestational weeks,
- written informed consent.
Who cannot join
- pregnant women with a BMI< 18.5 kg/m2,
- congenital anomaly of fetus,
- severe maternal diseases of heart, liver, kidney, cardiovascular system, gastrointestinal tract, neurologic disorders and psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Serum Hepcidin and Iron Status Parameters in Pregnant Women and the Association With Adverse Maternal and Fetal Outcome
Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to be overexpressed and correlated with low iron status. The increased hepcidin may restrain the iron release from the cells by affecting the expression of ferroportin, which probably associates with the development of diabetes complication. Firstly, investigator examines the difference of serum hepcidin and iron parameters between obese and non-obese pregnant women; secondly, the correlation between serum hepcidin and adverse maternal and neonatal outcomes in pregnant women will be tested.
Read the detailed description
This is a mono-center, observational, controlled study with 2 parallel groups (obese versus non-obese pregnant women). The study will be conducted at the University Hospital of Basel, Department of Obstetrics and Antenatal Care. A total of N=188 healthy pregnant women (expected 40% with BMI ≥ 30 kg/m2) will be recruited in the first trimester in our outpatients' department in order to have a total of 169 evaluable women, considering a drop-out rate of 10%. Serum hepcidin, iron and hematological parameters will be measured at 11-14, 24-28, 32-36 weeks of gestation and at labor. The blood pressure, weight, weight gain, BMI and smoking status will be examined at all visits. Blood samples will be measured in the University Hospital of Basel, Department of Laboratory Medicine. Recruitment will begin in January 2019.
- Conditions
- Anemia
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hepcidin at 11-14 weeks of gestation
serum hepcidin (ng/ml)
Measured: 11-14 weeks of gestation
Secondary outcomes (11)
Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor;
serum hepcidin (ng/ml)
Measured: at 24-28, 32-36 weeks of gestation
serum ferritin (µg/l),
iron status Parameter
Measured: at 24-28, 32-36 weeks of gestation
HRC (%),
blood parameter
Measured: at 11-14, 24-28, 32-36 weeks of gestation
hemoglobin (g/l),
blood parameter
Measured: at 11-14, 24-28, 32-36 weeks of gestation
red blood cells (x1012/l),
blood parameter
Measured: at 11-14, 24-28, 32-36 weeks of gestation
hematocrit (l/l),
blood parameter
Measured: at 11-14, 24-28, 32-36 weeks of gestation
MCV (fl),
blood parameter
Measured: at 11-14, 24-28, 32-36 weeks of gestation
MCH (pg),
blood parameter
Measured: at 11-14, 24-28, 32-36 weeks of gestation
MCHC (g/l),
blood parameter
Measured: at 11-14, 24-28, 32-36 weeks of gestation
red blood cell distribution width (%)
blood parameter
Measured: at 11-14, 24-28, 32-36 weeks of gestation
soluble transferrin receptors (mg/l)
iron status Parameter
Measured: at 24-28, 32-36 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start30 Apr 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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 AnemiaStudies 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
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriela Amstad Bencaiova, Principal investigator, Department of Obsterics, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792464
- Sponsor's protocol ID
- 2017-02322
- Other IDs
- 2017
- Status last verified
- Nov 2021
- First submitted
- 3 Dec 2018
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amstad G, Geiger J, Werlen L, Montavon C, Heinzelmann V. Perioperative management with ferric carboxymaltose and tranexamic acid to reduce transfusion rate in gynaecological carcinoma surgery (TRANAFER-Study): study protocol for a single-blind, monocentre, randomised trial. BMJ Open. 2022 Sep 26;12(9):e057381. doi: 10.1136/bmjopen-2021-057381.
PubMed 36167367Amstad Bencaiova G, Vogt DR, Hoesli I. Serum hepcidin and iron status parameters in pregnant women and the association with adverse maternal and fetal outcomes: a study protocol for a prospective cohort study. BMJ Open. 2019 Nov 6;9(11):e032280. doi: 10.1136/bmjopen-2019-032280.
PubMed 31699745
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Hepcidin and Iron Status Parameters in Pregnant Women and the Association With Adverse Maternal and Fetal Outcome
- ClinicalTrials.gov ID
- NCT03792464
- Acronym / sponsor ID
- 2017-02322
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 3 Jan 2019 (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.
Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to be overexpressed and correlated with low iron status. The increased hepcidin may restrain the iron release from the cells by affecting the expression of ferroportin, which probably associates with the development of diabetes complication. Firstly, investigator examines the difference of serum hepcidin and iron parameters between obese and non-obese pregnant women; secondly, the correlation between serum hepcidin and adverse maternal and neonatal outcomes in pregnant women will be tested.
Detailed description
This is a mono-center, observational, controlled study with 2 parallel groups (obese versus non-obese pregnant women). The study will be conducted at the University Hospital of Basel, Department of Obstetrics and Antenatal Care. A total of N=188 healthy pregnant women (expected 40% with BMI ≥ 30 kg/m2) will be recruited in the first trimester in our outpatients' department in order to have a total of 169 evaluable women, considering a drop-out rate of 10%. Serum hepcidin, iron and hematological parameters will be measured at 11-14, 24-28, 32-36 weeks of gestation and at labor. The blood pressure, weight, weight gain, BMI and smoking status will be examined at all visits. Blood samples will be measured in the University Hospital of Basel, Department of Laboratory Medicine. Recruitment will begin in January 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 188 singleton pregnancies will be recruited in the first trimester at the University Hospital of Basel, Department of Obstetrics and Antenatal Care.
Key inclusion criteria (5 listed)
- women with a BMI ≥ 18.5 kg/m2,
- maternal age ≥ 18 years,
- singleton pregnancy,
- gestational age at recruitment: 11-14 of gestational weeks,
- written informed consent.
Key exclusion criteria (3 listed)
- pregnant women with a BMI< 18.5 kg/m2,
- congenital anomaly of fetus,
- severe maternal diseases of heart, liver, kidney, cardiovascular system, gastrointestinal tract, neurologic disorders and psychiatric disorders.
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
Serum hepcidin at 11-14 weeks of gestation
Time frame: 11-14 weeks of gestation
serum hepcidin (ng/ml)
11 secondary outcomes
Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor;
Time frame: at 24-28, 32-36 weeks of gestation
serum ferritin (µg/l),
Time frame: at 24-28, 32-36 weeks of gestation
HRC (%),
Time frame: at 11-14, 24-28, 32-36 weeks of gestation
hemoglobin (g/l),
Time frame: at 11-14, 24-28, 32-36 weeks of gestation
red blood cells (x1012/l),
Time frame: at 11-14, 24-28, 32-36 weeks of gestation
hematocrit (l/l),
Time frame: at 11-14, 24-28, 32-36 weeks of gestation
MCV (fl),
Time frame: at 11-14, 24-28, 32-36 weeks of gestation
MCH (pg),
Time frame: at 11-14, 24-28, 32-36 weeks of gestation
MCHC (g/l),
Time frame: at 11-14, 24-28, 32-36 weeks of gestation
red blood cell distribution width (%)
Time frame: at 11-14, 24-28, 32-36 weeks of gestation
soluble transferrin receptors (mg/l)
Time frame: at 24-28, 32-36 weeks of gestation
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 11 Nov 2021.
- Derived from this study: PubMed 36167367Amstad G, Geiger J, Werlen L, Montavon C, Heinzelmann V. Perioperative management with ferric carboxymaltose and tranexamic acid to reduce transfusion rate in gynaecological carcinoma surgery (TRANAFER-Study): study protocol for a single-blind, monocentre, randomised trial. BMJ Open. 2022 Sep 26;12(9):e057381. doi: 10.1136/bmjopen-2021-057381.
- Derived from this study: PubMed 31699745Amstad Bencaiova G, Vogt DR, Hoesli I. Serum hepcidin and iron status parameters in pregnant women and the association with adverse maternal and fetal outcomes: a study protocol for a prospective cohort study. BMJ Open. 2019 Nov 6;9(11):e032280. doi: 10.1136/bmjopen-2019-032280.
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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.
Gabriela Amstad Bencaiova principal investigator
Department of Obsterics, University Hospital of 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 Anemia, 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 5 inclusion and 3 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 11 Nov 2021. 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?
Serum hepcidin at 11-14 weeks of gestation (time frame: 11-14 weeks of gestation). 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 NCT03792464, 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 11 Nov 2021.