Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome

Completed

• Conditions: Anemia

• Registration Number: NCT03792464
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-30
• Study First Posted: 2019-01-03
• Study Start: 2019-04-30
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 188

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum hepcidin at 11-14 weeks of gestation	11-14 weeks of gestation	serum hepcidin (ng/ml)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel Stadt, Switzerland