Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Serum Hepcidin and Iron Status Parameters in Pregnant Women and the Association With Adverse Maternal and Fetal Outcome

Conditions
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Anemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hepcidin at 11-14 weeks of gestation | serum hepcidin (ng/ml) | 11-14 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor; | serum hepcidin (ng/ml) | at 24-28, 32-36 weeks of gestation | 
| serum ferritin (µg/l), | iron status Parameter | at 24-28, 32-36 weeks of gestation | 
| HRC (%), | blood parameter | at 11-14, 24-28, 32-36 weeks of gestation | 
| hemoglobin (g/l), | blood parameter | at 11-14, 24-28, 32-36 weeks of gestation | 
| red blood cells (x1012/l), | blood parameter | at 11-14, 24-28, 32-36 weeks of gestation | 
| hematocrit (l/l), | blood parameter | at 11-14, 24-28, 32-36 weeks of gestation | 
| MCV (fl), | blood parameter | at 11-14, 24-28, 32-36 weeks of gestation | 
| MCH (pg), | blood parameter | at 11-14, 24-28, 32-36 weeks of gestation | 
| MCHC (g/l), | blood parameter | at 11-14, 24-28, 32-36 weeks of gestation | 
| red blood cell distribution width (%) | blood parameter | at 11-14, 24-28, 32-36 weeks of gestation | 
| soluble transferrin receptors (mg/l) | iron status Parameter | at 24-28, 32-36 weeks of gestation |