Clinical trial NCT03792464: Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome
Official title: Serum Hepcidin and Iron Status Parameters in Pregnant Women and the Association With Adverse Maternal and Fetal Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Serum hepcidin at 11-14 weeks of gestation
timeFrame: 11-14 weeks of gestation
Secondary outcomes:
measure: Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor;
timeFrame: at 24-28, 32-36 weeks of gestation
measure: serum ferritin (µg/l),
timeFrame: at 24-28, 32-36 weeks of gestation
measure: HRC (%),
timeFrame: at 11-14, 24-28, 32-36 weeks of gestation
measure: hemoglobin (g/l),
timeFrame: at 11-14, 24-28, 32-36 weeks of gestation
measure: red blood cells (x1012/l),
timeFrame: at 11-14, 24-28, 32-36 weeks of gestation
measure: hematocrit (l/l),
timeFrame: at 11-14, 24-28, 32-36 weeks of gestation
measure: MCV (fl),
timeFrame: at 11-14, 24-28, 32-36 weeks of gestation
measure: MCH (pg),
timeFrame: at 11-14, 24-28, 32-36 weeks of gestation
measure: MCHC (g/l),
timeFrame: at 11-14, 24-28, 32-36 weeks of gestation
measure: red blood cell distribution width (%)
timeFrame: at 11-14, 24-28, 32-36 weeks of gestation
measure: soluble transferrin receptors (mg/l)
timeFrame: at 24-28, 32-36 weeks of gestation
Other outcomes:
measure: preeclampsia (presence: yes/no)
timeFrame: from 11 week of gestation to the 3 days after the birth
measure: pregnancy induced hypertension (presence: yes/no),
timeFrame: from 11 week of gestation to the birth
measure: infection in pregnancy (presence: yes/no),
timeFrame: from 11 week of gestation to the 5 days after the birth
measure: anemia (presence: yes/no)
timeFrame: from 11 week of gestation to 3 days after the birth
measure: iron deficiency (presence: yes/no),
timeFrame: from 11 week of gestation to the birth
measure: cholestasis in pregnancy (presence:yes/no),
timeFrame: from 11 week of gestation to the birth
measure: gestational diabetes mellitus (presence: yes/no),
timeFrame: from 11 week of gestation to the birth
measure: abnormal placentation (presence: yes/no),
timeFrame: from 11 week of gestation to the birth
measure: blood loss during birth (ml)
timeFrame: at the birth
measure: transfusion requirement (presence: yes/no)
timeFrame: at the birth
measure: gestational age at birth (gestational week and day)
timeFrame: at the birth
measure: birth weight (g)
timeFrame: at the birth
measure: preterm delivery (presence: yes/no)
timeFrame: at the birth
measure: preterm premature rupture of fetal membrane (presence: yes/no)
timeFrame: at the birth
measure: intrauterine growth restriction (yes/no)
timeFrame: from 11 week of gestation to the birth
measure: intrauterine fetal death
timeFrame: from 11 week of gestation to the birth
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
affiliation: Department of Obsterics, University Hospital of Basel
name: Gabriela Amstad Bencaiova
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.