Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome
Study Details
Study Description
Brief 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 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.
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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
Outcome Measures
Primary Outcome Measures
- Serum hepcidin at 11-14 weeks of gestation [11-14 weeks of gestation]
serum hepcidin (ng/ml)
Secondary Outcome Measures
- Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor; [at 24-28, 32-36 weeks of gestation]
serum hepcidin (ng/ml)
- serum ferritin (µg/l), [at 24-28, 32-36 weeks of gestation]
iron status Parameter
- HRC (%), [at 11-14, 24-28, 32-36 weeks of gestation]
blood parameter
- hemoglobin (g/l), [at 11-14, 24-28, 32-36 weeks of gestation]
blood parameter
- red blood cells (x1012/l), [at 11-14, 24-28, 32-36 weeks of gestation]
blood parameter
- hematocrit (l/l), [at 11-14, 24-28, 32-36 weeks of gestation]
blood parameter
- MCV (fl), [at 11-14, 24-28, 32-36 weeks of gestation]
blood parameter
- MCH (pg), [at 11-14, 24-28, 32-36 weeks of gestation]
blood parameter
- MCHC (g/l), [at 11-14, 24-28, 32-36 weeks of gestation]
blood parameter
- red blood cell distribution width (%) [at 11-14, 24-28, 32-36 weeks of gestation]
blood parameter
- soluble transferrin receptors (mg/l) [at 24-28, 32-36 weeks of gestation]
iron status Parameter
Other Outcome Measures
- preeclampsia (presence: yes/no) [from 11 week of gestation to the 3 days after the birth]
maternal outcome
- pregnancy induced hypertension (presence: yes/no), [from 11 week of gestation to the birth]
maternal outcome
- infection in pregnancy (presence: yes/no), [from 11 week of gestation to the 5 days after the birth]
maternal outcome
- anemia (presence: yes/no) [from 11 week of gestation to 3 days after the birth]
maternal outcome
- iron deficiency (presence: yes/no), [from 11 week of gestation to the birth]
maternal outcome
- cholestasis in pregnancy (presence:yes/no), [from 11 week of gestation to the birth]
maternal outcome
- gestational diabetes mellitus (presence: yes/no), [from 11 week of gestation to the birth]
maternal outcome
- abnormal placentation (presence: yes/no), [from 11 week of gestation to the birth]
maternal outcome
- blood loss during birth (ml) [at the birth]
maternal outcome
- transfusion requirement (presence: yes/no) [at the birth]
maternal outcome
- gestational age at birth (gestational week and day) [at the birth]
neonatal outcome
- birth weight (g) [at the birth]
neonatal outcome
- preterm delivery (presence: yes/no) [at the birth]
neonatal outcome
- preterm premature rupture of fetal membrane (presence: yes/no) [at the birth]
neonatal outcome
- intrauterine growth restriction (yes/no) [from 11 week of gestation to the birth]
neonatal outcome
- intrauterine fetal death [from 11 week of gestation to the birth]
neonatal outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
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women with a BMI ≥ 18.5 kg/m2,
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maternal age ≥ 18 years,
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singleton pregnancy,
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gestational age at recruitment: 11-14 of gestational weeks,
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written informed consent.
Exclusion Criteria:
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pregnant women with a BMI< 18.5 kg/m2,
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congenital anomaly of fetus,
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severe maternal diseases of heart, liver, kidney, cardiovascular system, gastrointestinal tract, neurologic disorders and psychiatric disorders.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Basel | Basel | Basel Stadt | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Gabriela Amstad Bencaiova, Department of Obsterics, University Hospital of Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-02322