Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792464
• Other study ID #: 2017-02322
• Status: Completed
• Start date: April 30, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	preeclampsia (presence: yes/no)	maternal outcome	from 11 week of gestation to the 3 days after the birth
Other	pregnancy induced hypertension (presence: yes/no),	maternal outcome	from 11 week of gestation to the birth
Other	infection in pregnancy (presence: yes/no),	maternal outcome	from 11 week of gestation to the 5 days after the birth
Other	anemia (presence: yes/no)	maternal outcome	from 11 week of gestation to 3 days after the birth
Other	iron deficiency (presence: yes/no),	maternal outcome	from 11 week of gestation to the birth
Other	cholestasis in pregnancy (presence:yes/no),	maternal outcome	from 11 week of gestation to the birth
Other	gestational diabetes mellitus (presence: yes/no),	maternal outcome	from 11 week of gestation to the birth
Other	abnormal placentation (presence: yes/no),	maternal outcome	from 11 week of gestation to the birth
Other	blood loss during birth (ml)	maternal outcome	at the birth
Other	transfusion requirement (presence: yes/no)	maternal outcome	at the birth
Other	gestational age at birth (gestational week and day)	neonatal outcome	at the birth
Other	birth weight (g)	neonatal outcome	at the birth
Other	preterm delivery (presence: yes/no)	neonatal outcome	at the birth
Other	preterm premature rupture of fetal membrane (presence: yes/no)	neonatal outcome	at the birth
Other	intrauterine growth restriction (yes/no)	neonatal outcome	from 11 week of gestation to the birth
Other	intrauterine fetal death	neonatal outcome	from 11 week of gestation to the birth
Primary	Serum hepcidin at 11-14 weeks of gestation	serum hepcidin (ng/ml)	11-14 weeks of gestation
Secondary	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
Secondary	serum ferritin (µg/l),	iron status Parameter	at 24-28, 32-36 weeks of gestation
Secondary	HRC (%),	blood parameter	at 11-14, 24-28, 32-36 weeks of gestation
Secondary	hemoglobin (g/l),	blood parameter	at 11-14, 24-28, 32-36 weeks of gestation
Secondary	red blood cells (x1012/l),	blood parameter	at 11-14, 24-28, 32-36 weeks of gestation
Secondary	hematocrit (l/l),	blood parameter	at 11-14, 24-28, 32-36 weeks of gestation
Secondary	MCV (fl),	blood parameter	at 11-14, 24-28, 32-36 weeks of gestation
Secondary	MCH (pg),	blood parameter	at 11-14, 24-28, 32-36 weeks of gestation
Secondary	MCHC (g/l),	blood parameter	at 11-14, 24-28, 32-36 weeks of gestation
Secondary	red blood cell distribution width (%)	blood parameter	at 11-14, 24-28, 32-36 weeks of gestation
Secondary	soluble transferrin receptors (mg/l)	iron status Parameter	at 24-28, 32-36 weeks of gestation