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Completed

NCT Number: NCT03792464

Serum Hepcidin in Pregnant Women and the Association With Pregnancy 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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Serum hepcidin at 11-14 weeks of gestation

    Time frame: 11-14 weeks of gestation

    serum hepcidin (ng/ml)

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 3, 2019
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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