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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Serum hepcidin at 11-14 weeks of gestation | serum hepcidin (ng/ml) | 11-14 weeks of gestation |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| preeclampsia (presence: yes/no) | maternal outcome | from 11 week of gestation to the 3 days after the birth |
| pregnancy induced hypertension (presence: yes/no), | maternal outcome |
Inclusion Criteria:
Exclusion Criteria:
pregnant women
188 singleton pregnancies will be recruited in the first trimester at the University Hospital of Basel, Department of Obstetrics and Antenatal Care.
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| Name | Affiliation | Role |
|---|---|---|
| Gabriela Amstad Bencaiova | Department of Obsterics, University Hospital of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36167367 | Derived | 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. | |
| 31699745 |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Hematological and serum iron parameters will be determined using routine laboratory methodology. Blood samples are collected by venipuncture. All blood measurements will be conducted at the University Hospital of Basel, Department of Laboratory Medicine.
Hb, RBC, HCT, MCV, MCHC, MRC, HRC and CHr are measured using a hematology analyzer. Mean corpuscular hemoglobin is automatically calculated from Hb and RBC. Ferritin is assessed by chemiluminescence immunoassay and CRP is assessed by immunoturbidimetry. Soluble transferrin receptors and serum hepcidin are measured with an ELISA.
| 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 |
| from 11 week of gestation to the birth |
| infection in pregnancy (presence: yes/no), | maternal outcome | from 11 week of gestation to the 5 days after the birth |
| anemia (presence: yes/no) | maternal outcome | from 11 week of gestation to 3 days after the birth |
| iron deficiency (presence: yes/no), | maternal outcome | from 11 week of gestation to the birth |
| cholestasis in pregnancy (presence:yes/no), | maternal outcome | from 11 week of gestation to the birth |
| gestational diabetes mellitus (presence: yes/no), | maternal outcome | from 11 week of gestation to the birth |
| abnormal placentation (presence: yes/no), | maternal outcome | from 11 week of gestation to the birth |
| blood loss during birth (ml) | maternal outcome | at the birth |
| transfusion requirement (presence: yes/no) | maternal outcome | at the birth |
| gestational age at birth (gestational week and day) | neonatal outcome | at the birth |
| birth weight (g) | neonatal outcome | at the birth |
| preterm delivery (presence: yes/no) | neonatal outcome | at the birth |
| preterm premature rupture of fetal membrane (presence: yes/no) | neonatal outcome | at the birth |
| intrauterine growth restriction (yes/no) | neonatal outcome | from 11 week of gestation to the birth |
| intrauterine fetal death | neonatal outcome | from 11 week of gestation to the birth |
| Amstad 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. |