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Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome

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ClinicalTrials.gov Identifier: NCT03792464
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease
Anemia

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.

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Study Type : Observational
Estimated Enrollment : 188 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Hepcidin and Iron Status Parameters in Pregnant Women and the Association With Adverse Maternal and Fetal Outcome
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron




Primary Outcome Measures :
  1. Serum hepcidin at 11-14 weeks of gestation [ Time Frame: 11-14 weeks of gestation ]
    serum hepcidin (ng/ml)


Secondary Outcome Measures :
  1. Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor; [ Time Frame: at 24-28, 32-36 weeks of gestation ]
    serum hepcidin (ng/ml)

  2. serum ferritin (µg/l), [ Time Frame: at 24-28, 32-36 weeks of gestation ]
    iron status Parameter

  3. HRC (%), [ Time Frame: at 11-14, 24-28, 32-36 weeks of gestation ]
    blood parameter

  4. hemoglobin (g/l), [ Time Frame: at 11-14, 24-28, 32-36 weeks of gestation ]
    blood parameter

  5. red blood cells (x1012/l), [ Time Frame: at 11-14, 24-28, 32-36 weeks of gestation ]
    blood parameter

  6. hematocrit (l/l), [ Time Frame: at 11-14, 24-28, 32-36 weeks of gestation ]
    blood parameter

  7. MCV (fl), [ Time Frame: at 11-14, 24-28, 32-36 weeks of gestation ]
    blood parameter

  8. MCH (pg), [ Time Frame: at 11-14, 24-28, 32-36 weeks of gestation ]
    blood parameter

  9. MCHC (g/l), [ Time Frame: at 11-14, 24-28, 32-36 weeks of gestation ]
    blood parameter

  10. red blood cell distribution width (%) [ Time Frame: at 11-14, 24-28, 32-36 weeks of gestation ]
    blood parameter

  11. soluble transferrin receptors (mg/l) [ Time Frame: at 24-28, 32-36 weeks of gestation ]
    iron status Parameter


Other Outcome Measures:
  1. preeclampsia (presence: yes/no) [ Time Frame: from 11 week of gestation to the 3 days after the birth ]
    maternal outcome

  2. pregnancy induced hypertension (presence: yes/no), [ Time Frame: from 11 week of gestation to the birth ]
    maternal outcome

  3. infection in pregnancy (presence: yes/no), [ Time Frame: from 11 week of gestation to the 5 days after the birth ]
    maternal outcome

  4. anemia (presence: yes/no) [ Time Frame: from 11 week of gestation to 3 days after the birth ]
    maternal outcome

  5. iron deficiency (presence: yes/no), [ Time Frame: from 11 week of gestation to the birth ]
    maternal outcome

  6. cholestasis in pregnancy (presence:yes/no), [ Time Frame: from 11 week of gestation to the birth ]
    maternal outcome

  7. gestational diabetes mellitus (presence: yes/no), [ Time Frame: from 11 week of gestation to the birth ]
    maternal outcome

  8. abnormal placentation (presence: yes/no), [ Time Frame: from 11 week of gestation to the birth ]
    maternal outcome

  9. blood loss during birth (ml) [ Time Frame: at the birth ]
    maternal outcome

  10. transfusion requirement (presence: yes/no) [ Time Frame: at the birth ]
    maternal outcome

  11. gestational age at birth (gestational week and day) [ Time Frame: at the birth ]
    neonatal outcome

  12. birth weight (g) [ Time Frame: at the birth ]
    neonatal outcome

  13. preterm delivery (presence: yes/no) [ Time Frame: at the birth ]
    neonatal outcome

  14. preterm premature rupture of fetal membrane (presence: yes/no) [ Time Frame: at the birth ]
    neonatal outcome

  15. intrauterine growth restriction (yes/no) [ Time Frame: from 11 week of gestation to the birth ]
    neonatal outcome

  16. intrauterine fetal death [ Time Frame: from 11 week of gestation to the birth ]
    neonatal outcome


Biospecimen Retention:   Samples Without DNA

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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
188 singleton pregnancies will be recruited in the first trimester at the University Hospital of Basel, Department of Obstetrics and Antenatal Care.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792464


Contacts
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Contact: Gabriela Amstad Bencaiova, MD +41 61 556 5922 gabriela.amstad@usb.ch

Locations
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Switzerland
University Hospital Basel Recruiting
Basel, Basel Stadt, Switzerland, 4031
Contact: Gabriela Amstad Bencaiova, MD, Dr.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Gabriela Amstad Bencaiova Department of Obsterics, University Hospital of Basel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03792464    
Other Study ID Numbers: 2017-02322
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No